Popular Pharmaceuticals Ltd.

Product Development Department

Development Status of Top Priority New Products

Dosage Form
SL. Product Name Or Proposal
(With Shape, PD Material Status
No. Generic Name with Strength received
Size & Color)

Amitriptyline 12.5 mg and

1 Tablet Sep’17 Available
Chlordiazepoxide 5 mg tablet

2 Astaxanthin 2 mg Capsule Capsule Oct’18 Available. RM Analysis Running

3 Astaxanthin 4 mg Capsule Capsule Oct’18 Available. RM Analysis Running

Betahistine Dihydrochloride 16 mg
4 Tablet July' 18 Available
Tablet
Betahistine Dihydrochloride 8 mg
5 Tablet July' 18 Available
Tablet
6 Calcium Dobesilate 500 mg Capsule Capsule Jun'18 Available

7 Cholecalciferol 50,000 IU Tablet Tablet 43807 Cholecalciferol 50,000 IU (BNF)

Cholecalciferol BP 200,000 IU Waiting for new API from DSM
8 Injection Jul/18
Injection Mail sent on Nov'19
9 Dantrolene Sodium 25 mg Capsule Capsule Oct’17 Available

10 Dantrolene Sodium 50 mg Capsule Capsule Oct’17 Available

Doxylamine Succinate USP 20 mg +

Doxylamine Succinate received
11 Pyridoxine Hydrochloride BP 20 mg ER Tablet Jun/18
27.11.19
Tablet

12 Duloxetine; 20 mg, 30 mg Tablet Dec'19 No QC sample received

13 Ferric Pyrophosphate Citrate 5 ml Injection Available

Glucosamine 750 mg
14 Tablet Nov'19 N/A
Condroitin 600 mg Tablet

Hydroquinone USP 4% +
15 Fluocinolone BP 0.01% + Tretinoin Cream Aug'08 Available
BP 0.05% Cream
Jakloc 11 XR (Tofacitinib Citrate INN
16 XR Tablet Nov'17 Available
11 mg) Tablet
17 Levetiracetam 500 mg Tablet Oct'18 PD Sample Received 21.09.19
18 Levetiracetam 500 mg/ 5 ml Oral Solution Oct'18 PD Sample Received 21.09.19
Levodopa + Carbidopa; PD sample received Levodopa:
19 Tablet Dec'19
250 mg + 25 mg 03.08.19 & Carbodopa: 06.08.020

Levodopa + Carbidopa; PD sample received Levodopa:

20 Tablet Dec'19
100 mg + 10 mg 03.08.19 & Carbodopa: 06.08.019
21 Mirtazapine 15 mg Tablet Tablet Dec'20 No QC sample received
22 Mirtazapine 7.5 mg Tablet Tablet Dec'19 No QC sample received
QC sample approved. Waiting for
23 Mupirocin 2% Ointment Ointment Sep/16
PD sample.
Prucalopride Succinate INN 1mg
24 Tablet Mar'19 Available
Tablet
Prucalopride Succinate INN 2mg
25 Tablet Mar'19 Available
Tablet
Two QC sample received
(10.11.18 & 10.01.19). Test
26 Quetiapine Fumarate FC 100 mg Tablet Oct'18
result found satisfactory & wating
for document.
Two QC sample received
(10.11.18 & 10.01.19). Test
27 Quetiapine Fumarate FC 200 mg XR Tablet Oct'18
result found satisfactory & wating
for document.
Two QC sample received
(10.11.18 & 10.01.19). Test
28 Quetiapine Fumarate FC 25 mg Tablet Oct'18
result found satisfactory & wating
for document.
Two QC sample received
(10.11.18 & 10.01.19). Test
29 Quetiapine Fumarate FC 50 mg XR Tablet Oct'18
result found satisfactory & wating
for document.
30 Rivastigmine Tartrate 1.5 Capsule Capsule Jun’18 Available
31 Rivastigmine Tartrate 3 Capsule Capsule Jun’18 Available
32 Safinamide 100 mg Tablet Tablet Jul’18 Available

33 Safinamide 50 mg Tablet Tablet Jul’18 Available

One QC sample rec. Waiting for
34 Sevelamer Carbonate 800 mg Tablet Tablet 43766
more sample.
35 Silodosin 4 mg capsule (#4) Capsule Jun'19 Available
36 Silodosin INN 8mg Capsule (#4) Capsule Jun'18 Available

37 Tamsulosin HCl USP 0.4mg Capsule ER Capsule Jul'18 Development sample available
Tamsulosin Hydrochloride USP
0.4mg mg + Dutasteride USP 0.5 mg Capsule
38 Sep'18 Development sample received:
IR Capsule (SR+IR)

39 Tolvaptan INN 15 mg Tablet Tablet Jul'18 Source approved

Triamcinolone 0.1% + Econazole 1% QC sample approved. Waiting for

40 Cream 42639
(Acetonide) Cream PD sample.
 Effervescent
41 Acetylcysteine 600 mg Dec’19 No QC sample received
tablet
42 Brivaracetam 25 mg Tablet Oct/18 PD Sample Received 30.11.19
43 Brivaracetam 50 mg Tablet Oct/18 PD Sample Received 30.11.19

Clindamycin Phosphate USP 1% + Gel in

44 Benzoyl Peroxide USP 5% Gel, laminated Available
25gm tube.

Ferric Carboxymaltose INN

45 100mg/2ml (500mg/10ml, Injection Oct'17 Available
750mg/15ml, 1000mg/20ml vial)
Furosemide 40 mg + Spironolactone
46 Tablet Jun/18 Existing
50 mg
Levodopa USP 100 + Carbidopa
47 USP 20 + Entacapone USP 200mg Tablet Jul'18 Available
Tablet
Levodopa USP 50 + Carbidopa USP
48 12.5 + Entacapone USP 200mg Tablet Jul'18 Available
Tablet
Lidocaine Hydrochloride; 20 mg/ml Subcutaneous
49 Injection
Dec’19 Available
solution (50 ml)
Innovator product is required for
setting dissolution specification.
Memantine HCl INN + Donepezil Hcl Requisition raised on 12.10.2019
50 INN ER Capsule Jul'18 for innovator. Although
manufacturer has been provided
us dissolution profile with
innovator’s product.
Development sample received
51 Memantine Hydrochloride 10 mg Tablet Jul'18
07.12.19. Test Not Done
Development sample received
52 Memantine Hydrochloride 5 mg Tablet Jul'18
07.12.19. Test Not Done
Injectable 1 QC sample sent to PD. Waiting
53 Menbutone 100mg/ml Apr'19
Solution for another source.
54 Nitrofurantoin USP 100 mg SR Capsule Jun'18 No QC sample received
55 Sodium Valporate 200mg CR Tablet
56 Sodium Valporate 200mg/ 5 ml Syrup Oct'18 PD Sample Received 11.07.19
57 Sodium Valporate 300mg CR Tablet
58 Sodium Valporate 500mg CR Tablet
59 Tolvaptan INN 30 mg Tablet Tablet Jul'18 Source approved
60 Trihexyphenidyl 5 mg Tablet Dec'19 No QC sample received
61 Trihexyphenidyl 2 mg Tablet Dec'19 No QC sample received
Sourcing ongoing. QC sample will
62 Valbenazine INN 40mg Capsule Capsule Jul'18 be available soonest from Hetero
Drugs Ltd.
Sourcing ongoing. QC sample will
63 Valbenazine INN 80mg Capsule Capsule Jul'18 be available soonest from Hetero
Drugs Ltd.
64 Cranberry Extract 400 mg Capsule Jun/18 Waiting for test reagent
 PMD informed via Email, they are
Pentosan Polysulfate Sodium 100 not interested to buy innovator's
65 Capsule Jun'18
mg product (1st time in BD), due to
high price. Test not done.

Two QC sample received

(18.12.18 & 25.02.19) from same
66 Perampanel 2 mg Tablet Oct'18
manufacturer, Waiting for another
sample.
Two QC sample received
(18.12.18 & 25.02.19) from same
67 Perampanel 4 mg Tablet Oct'18
manufacturer, Waiting for another
sample.
QC sample received (14.02.19 &
68 Pimavanserin Tartrate 17 mg Tablet Jul'18 28.09.19). Waiting for source
approval & document.
QC sample from Bloomage Freda
Biopharma Co. Ltd. China has
Pre-filled
Sodium Hyaluronate USP 20mg/ 2ml been received on 23.09.2019
69 Syringe Feb'18
intra-articular Injection which does not meet our
(Injection)
purchase specification in respect
of intrinsic viscosity.
QC sample received 10.03.19.
70 Tetrabenazine 12.5 mg Tablet Jul'18 QC sample approved, waiting for
PD sample.
QC sample received 10.03.19.
71 Tetrabenazine 25 mg Tablet Jul'18 QC sample approved, waiting for
PD sample.
Vitamin B complex + Vitamin C; 10
lyophilized IV
72 ml vial with 100 ml 5% dextrose Nov' 19
infusion
solution
Vitamin B complex + Vitamin C; 10 lyophilized IV
73 Nov' 19
ml vial with 100 ml normal saline infusion
74 Levetiracetam 250 mg Tablet Oct'18 PD Sample Received 21.09.19
75 Levetiracetam ER 750 mg ER Tablet Oct'18 PD Sample Received 21.09.19
Levodopa USP 150 + Carbidopa
76 USP 37.5 + Entacapone USP Tablet Jul'18 Available
200mg Tablet
Levodopa USP 200 + Carbidopa
77 USP 50 + Entacapone USP 200mg Tablet Jul'18 Available
Tablet

Amlodipine 5 mg + Telmisertan 40
1 Tablet Dec’18 Available
mg Tablet
Amlodipine 5 mg + Telmisertan 80
2 Tablet Dec’18 Available
mg Tablet
3 Telmisertan 40 mg Tablet Tablet Dec’18 Available
Metformin HCL BP 1000 mg+
4 ER Tablet 11/22/2017 Available
Linagliptin INN 2.5 mg tablet
Metformin HCL BP 1000 mg+
5 ER Tablet 11/22/2017 Available
Linagliptin INN 5mg tablet
 Metformin HCL BP XR 1000mg
6 XR Tablet Jul'17 Available
tablet
7 Metformin HCL BP XR 500mg tablet XR Tablet Jul'17 Available

8 Prazosin 2.5 mg Tablet ER Tablet May’18 Available

9 Prazosin 5 mg Tablet ER Tablet May’18 Available
10 Gliclazide 30 mg MR Tablet MR Tablet Apr’18 Available
11 Gliclazide 60 mg MR Tablet MR Tablet Apr’18 Available

Metformin HCL BP 500mg +

12 SR Tablet Feb'16 Available
Glimepride USP 1 mg tablet

Metformin HCL BP 500mg +

13 SR Tablet Feb'16 Available
Glimepride USP 2 mg tablet

14 Ranolazine 1000 mg ER Tablet Jun/18 PD sample received. 04.08.19

15 Ranolazine 500 mg ER Tablet Jun/18 PD sample received. 04.08.19

Coenzyme Q10 (Ubidecarenone API Available. EHGC Shell # 0

1 Capsule Not Available
USP) 100 mg Capsule Selected
2 Desogestrel 0.075 mg Tablet Tablet May’19 Available
QC sample approved. Waiting for
3 Dienogest 2mg Tablet Tablet Apr’19
PD sample
4 Elagolix Sodium 150mg Tablet Tablet Aug'18 N/A

5 FSH 150 IU Injection Lyo Injection Aug'17

6 HCG 10,000 IU Injection Lyo Injection Nov’19 Available

7 HCG 2,500 IU Injection Lyo Injection Nov’19 Available

8 HMG 150 IU Injection Lyo Injection

Development Status of Ophthalmic Products

Dosage Form
SL. Product Name Or Proposal
(With Shape, PD Material Status
No. Generic Name with Strength received
Size & Color)

Hyprogel Eye Ointment

(Hypromellose (Hydroxypropyl
1 Methylcellulose) Sterile USP Eye Ointment Feb'17
0.300gm/100gm)
10gm Laminated tube
 Lotenol Eye Ointment (Loteprednol
Etabonate (Micronized & Sterile) INN
2 Eye Ointment Ju'15
0.500gm/100gm),
3gm Alu Tube

3 Netarsudil INN 0.02% Eye Drops Eye Drops May/18 No QC sample received
Travoprost USP 0.004% Ophthalmic
4 Eye Drops Jun/18 No QC sample received
Solution
Visin Plus Eye Drops (Glycerin
USP0.2%, Hypromellose USP
5 0.36%, PEG 400 USP Eye Drops RM Available
1%,TetrahydrozolineHCl USP
0.05%, Zinc Sulphate USP 0.25%)
Netarsudil 0.02% + Latanoprost
6 Eye Drops May/19
0.005% Ophthalmic Solution
Sodium Hyaluronate USP 1.4% No QC sample for eye drop grade
7 Eye Drops Apr'12
Ophthalmic Solution is not received.
Source approved. Waiting for
8 Lifitegrast INN 5% Eye Drops Sep'16
Development sample.
Moxifloxacin HCL 0.5% (5 gram in
9 Eye Ointment May'17
lami tube)

Fluorometholone + Tetrahydrozoline
10 Eye Drops Dec'18
(0.1% + 0.025%)

Dosage Form
SL. Product Name Or Proposal
(With Shape, PD Material Status
No. Generic Name with Strength received
Size & Color)

Bromhexine HCl PD sample

Bromhexine HCl BP 20mg + Menthol
1 Oral Solution Jan/19 approved. Menthol- QC sample
BP 44mg/ml Oral Solution
not received

Ceftiofur HCl BP 50mg/ml Powder for QC sample approved and waiting

2 Jan/19
Suspension (Cephalosporin) Suspension for PD sample

Source approved. PD sample

Flunixine Meglumine USP 50mg/ml
3 Injection Jan/19 received on 02.01.2020. Test will
Injection
be completed within 15.01.2020

Levofloxacin BP 100mg/ml Vet Oral

4 Oral Solution May/19 Available
Solution 100 ml & 500 ml

800 gm PD sample received on

5 Meloxicam 100 mg Vet Bolus Bolus 02.01.20. Analysis will be
completed within 19.01.2020
800 gm PD sample received on
6 Meloxicam BP 50 mg/10ml Injection Injection 02.01.20. Analysis will be
completed within 19.01.2020
 Simethicone- Test result
satisfactory and document
Simethicone USP 10mg + Dill Oil BP pending. Dill Oil - Analysis will be
7 Suspension 43481
0.005ml/ml Suspension completed after getting
glassware. Requisition arised on
july, 2019
6.0 Kg PD sample received on
8 Tilmicosin Phosphate 250mg/ml Oral Solution Apr'19 19.12.2019. Analysis will be
completed within 19.01.2020
Vitamin A, D3, B1, B2, B6, B12, B5,
B3, Inositol, Methionin Choline
Injection
9 Citrate, Mg Hypophosphate, Cobalt 43788
(Ready)
Chloride, Copper Sulphate, Zinc
Sulphate, Mangan Sulphate

Bacillus Subtilis, Bacillus

licheniformis, Bacillus mesentericus,
Bacillus coagulans, Lactobacillus
10 plantarum, Lactobacillus acidophilus, Oral Powder Nov'19
pedilococcus faecalis, Enterococcus
faecium, Saccharomyces, Beta-
glucan,Mannan oligosaccharides

Mastilok
(Tri-Sodium citrate 25 gm, Vitamin A
- 10000 IU, Vitamin D3- 2000 IU,
Vitamin E- 800 mg, Vitamin H- 20
mg, Vitamin K- 20 mg, Selenium- 4
mg, Potassium Iodide 4 mg, Copper
As per manufacturer method
Sulphate 960 mg, Cobalt Sulphate
11 Oral Powder sample does not meet with
40 mg, Zn Sulphate 825 mg,
specification.
Manganese Sulphate 3000 mg,
Lactic acid Bacillus 2000 M CFU,
Live Yeast 50000 M CFU,
Serratopeptidase 32 mg, Bromelain
320 mg, Methionine 1500 mg, L-
Lysine 3000 mg)/60gm Sachet

Propylene glycol, Yest extract, Citric

acid, orthophosphoric acid, Lactic
acid, Vitamin C, Vitamin E, DL-
12 Oral Liquid Nov' 19 No QC sample available
Methionine, Megnesium sulphate,
Betamine, Mannitol, D-Sorbitol,
Carrier.

Development Status of Priority DCC Products

Dosage Form
SL. Product Name Or Proposal
(With Shape, PD Material Status
No. Generic Name with Strength received
Size & Color)

1 Bilastin 2.5mg/ml Syrup Syrup Sep’17 Available

2 Calcoral DX with Vitamin K2 Capsule Oct’18 Available

 Cefixime 100 mg & Clavulanic Acid
3 Tablet Nov’13 Available
62.5 mg per Tablet
Cefixime 200 mg & Clavulanic Acid
4 Tablet Nov’13 Available
125 mg per Tablet
Cefixime 50 mg & Clavulanic Acid
5 PFS Jul’18 Available
31.25 mg/5 ml PFS

6 Cefixime 500 mg/5ml PFS PFS Jun'17 Available

Frovatriptan Succinate INN 2.5 mg
7 Tablet Jul'19 Source approved
(USFDA)
8 Itopride Hydrochoride 50 Tablet Tablet Jan’18 Available
QC sample OK. Waiting for
9 Lornoxicam 4 mg (EMA) Tablet May’19
Source Approval Document
10 Lornoxicam 8 mg (EMA) Tablet May’19
11 Lornoxicam 8 mg/2ml (EMA) Lyo Injection May’19

12 Pegalin INN 165mg Tablet ER Tablet Feb'17 Available

13 Pegalin INN 82.5mg Tablet, ER Tablet Feb'17 Available

Phenylephrine Injection 0.5 mg/ 5 ml

14 Injection Oct’19 Available
Ampoule
Sodium Chloride 600 mg tablet (Alu
15 Tablet Mar'19 Available
Alu Blister)
16 Tenapanor INN 50 mg (USFDA) Tablet Oct’19 No QC sample received
17 Upadacitinib INN 15 (USFDA) mg ER Tablet Aug’19 No QC sample received
Fospropofol Disodium 35mg/ml (30
18 Injection
ml) (USFDA)

Aspirin BP 81mg + Omeprazole BP

19 Tablet Mar'17 Available
40 mg delayed release tablet

Two QC sample received.

20 Ferric Maltol 30mg Capsule Nov/19 Analysis will be completed within
15.01.2020
Glucosamine 1,500 mg Powder for
21 Dec’19 N/A
Condroitin 1,200 mg (Sachet) Solution
22 Ilaprazole 5 Tablet Tablet Jun’17 Available

23 Ilaprazole INN 10 mg Tablet Tablet Jun'17 Available

24 Ilaprazole INN 20 mg Tablet Tablet Jun'17 Available

25 Itopride Hydrochoride 150 Tablet SR Tablet Jan’18 Available

 QC sample received (13.10.19 &
26 Memantine Hydrochloride 14 mg ER Capsule Jul'18
23.09.19) test running.
QC sample received
27 Memantine Hydrochloride 7 mg ER Capsule Jul'18 (13.10.19 & 23.09.19)
Test running.
Sugammadex (as Sugammadex
28 IV Injection Dec’19
Sodium); 200 mg/2 ml
29 Vonoprazon 10 mg Tablet Tablet May'18 Available
30 Vonoprazon 20 mg Tablet Tablet May'18 Available
Cefiderocol, 1 gm powder
31 PFI Dec’19 No QC sample received
(Cephalosporin)

32 Pegalin INN 330mg Tablet ER Tablet Feb'17 Available

Ebastine BP 10mg + Montelukast

33 Tablet Available
BP 10mg

34 Rabigut PFI PFI (Lyo) Oct’17 Available

Empagliflozin INN 10 mg +
1 Tablet Dec’ 18 Available
Linagliptin 5 mg (USFDA)

Empagliflozin INN 5 mg + Metformin

2 ER Tablet Nov’ 18 Available
HCl BP 1000 mg (USFDA)

Empagliflozin INN 5 mg + Metformin

3 Tablet Nov’ 18 Available
HCl BP 500 mg (USFDA)

Gliclazide BP 80 mg + Metformin BP
4 Tablet Jan'16 Available
500 mg tablet

5 Benidipine HCL INN 2 mg tablet Tablet Apr’18 Available

6 Benidipine HCL INN 4 mg tablet Tablet Apr’18 Available

7 Benidipine HCL INN 8mg Tablet Tablet Apr'18 Available

8 Bisoprolol 5 + Amlodipine 5 Tablet Tablet Oct’11 Available

QC sample Ok. Document
9 Omarigliptin 12.5 mg Tablet Tablet Jul’18
Pending.
10 Omarigliptin 25 mg Tablet Tablet Jul’18
11 Semaglutide 14mgTablet Tablet Sep/19 No QC Sample available
12 Semaglutide 3mg Tablet Tablet Sep/19 No QC Sample available
13 Semaglutide 7mg Tablet Tablet 43735 No QC Sample available
14 Sotagliflozin 200 mg Tbalet Tablet Nov/19 No QC Sample available

Hydroxyprogesterone Caproate
1 Injection Nov’19 Available
(HPC) Injection 500mg/2 ml
 Natural Micronized Progesterone
2 SR Tablet May/19 Available
INN 200 mg Tablet
Natural Micronized Progesterone
3 SR Tablet Jan/18 Available
INN 300 mg Tablet
Corifollitropin alfa, 100 Micrograms
Injection
4 of Corifollitropin alfa in 0.5 ml Oct' 18 Sourcing running
(Liquid)
solution
Corifollitropin alfa, 150 Micrograms
Injection
5 of Corifollitropin alfa in 0.5 ml Oct' 18 Sourcing running
(Liquid)
solution
FSH (Follitropin alfa) (Recombinant)
6 Lyo Injection Aug'17 Source needed
INN 100 IU
L-carnitine INN 340 mg
+Ubidecarenone BP 50 mg +
Elemental Zinc INN 5 mg +
7 FC Tablet Dec’19 No QC Sample available
Lycopene USP 2.5 mg + Astaxanthin
INN 8 mg tablet (Fertility
Supplement)

Naphazoline 0.03% and

1 Hypromellose 0.5% Ophthalmic Eye Drops Jun'17 Available
Suspension
Carboxymethylcellulose Sodium +
2 Eye Drops Sep'18
Glycerin (0.5% + 0.9%)

New Proposal Received on 2019 - 2020

Dosage Form
SL. Product Name Or Proposal
(With Shape, PD Material Status
No. Generic Name with Strength received
Size & Color)

1 Sevelamer Carbonate 400 mg Tablet Tablet 43766

QC sample approved. Waiting for
2 Isotretinoin 0.05% Gel Gel Sep/16
PD sample.
3 Lasmiditan 50 mg Tablet Tablet Nov/19
4 Lasmiditan 100 mg Tablet Tablet Nov/19
Lefamulin (as Lefamulin Acetate)
5 Tablet 43751
600 mg Tablet
Lefamulin (as Lefamulin Acetate)
6 Injection 43751
150 mg Injection
Patiromer (as Patiromer Sorbitex
7 PFS 43766
Calcium) 8.4 gm PFS in Sachet
Patiromer (as Patiromer Sorbitex
8 PFS Oct/19
Calcium) 16.8 gm PFS in Sachet
Patiromer (as Patiromer Sorbitex
9 PFS Oct/19
Calcium) 25.2 gm PFS in Sachet
Granules for
Fosfomycin Trometamol 3 gm
10 Oral Solution Sep/18
Granules for Oral Solution
(Sachet)
11 Obeticholic Acid 25 mg Tablet Tablet Dec/19
 Paediatric
12 Domperidone 5mg/ml (15ml) 43843
Drops
13 Famotidine 20 mg Tablet 43837
14 Famotidine 40 mg Tablet 43837
Famotidine 10 mg + Calcium
Chewable
15 Carbonate 800 mg + Magnesium Jan/20
Tablet
Hydroxide 165 mg
16 Rivaroxaban 2.5 mg Tablet 43843
17 Rivaroxaban 10 mg Tablet 43843
18 Ticagrelor 90 mg Tablet Jan/20
Sulfadiazine + Neomycin Sulphate Oral
19 Jul/20
(150 mg + 25 mg per ml) Suspension
20 Marbofloxacin 50 mg Tablet Jul/20
21 Marbofloxacin 100 mg Injection Jul/20
22 Colecalciferol 1000 IU per 5 ml Syrup Jul/20
Fusidic acid + Hydrocortisone
23 Cream Mar/20
acetate (2% + 1%)
24 Esketamine HCL 25 mg per ml Injection Aug/20
25 Voriconazole 200 mg Tablet Apr/20
26 Nabumetone 500 mg Tablet Jan/20
27 Nabumetone 750 mg Tablet Jan/20
maceuticals Ltd.
pment Department

Top Priority New Products

Product Updated Priority

PD Status Regulatory Status
Group
Priority Proposed LY
(11.10.2020)

Annexure done
Product OK. Narcotic approval not (16.10.19)
GT 1 1 2020
done. Narcotic Product
Price Not Done
Lab Batch Analysis will be completed
by Jan'20. Stability will be started by
GT 1 2 2021
Feb'20. Recipe will send by
May'2020
Lab Batch Analysis will be completed
by Jan'20. Stability will be started by
GT 1 2 2021
Feb'20. Recipe will send by
May'2020
6 M: Jan'20 (Recipe send by 1st
GT 1 1 2020
week Feb'20
6 M: Jan'20 (Recipe send by 1st
GT 1 1 2020
week Feb'20)
6 M: May'20 (Recipe send by Mar'20) GT 1 1 2020

GT 1 2021
Recipe sent. Recipe sent to HO:
GT 1 1 2020
Pilot Batch to be done 11.11.19
2nd lab batch manufacturing to be
GT 1 1 2021
done within jan, 2020
2nd lab batch manufacturing to be
GT 1 2 2022
done within jan, 2020

6M: Jul'20.Recipe will be sent by

GT 1 1 2021
April'20

GT 1 1 2021
Decision
6 M: Mar'20 GT 1 2020
Required

GT 1 2 2021

Reformulation
6M: Apr’ 2020 GT 1 2 2021
required

Lab batch done. TRS needed. GT 1 1 2020

Lab batch will be started soon GT 1 1 2021

Lab batch will be started soon GT 1 1 2021

Lab batch will be started soon GT 2 2 2022

Lab batch will be started soon GT 1 1 2021

GT 1 1 2021
GT 1 1 2021
GT 1 1 2021
6 M: May’20.Recipe wil send by Recipe will sent to HO:
GT 1 1 2020
Feb'20 25.02.20
6 M: May’20.Recipe wil send by Recipe will sent to HO:
GT 1 1 2020
Feb'20 25.02.20

Development sample needed. Mail

GT 1 2 2021
sent 3rd Dec'19

Development sample needed. Mail

GT 2 3 2022
sent 3rd Dec'19

Development sample needed. Mail

GT 1 2 2021
sent 3rd Dec'19

Development sample needed. Mail

GT 2 3 2022
sent 3rd Dec'19

3M: Apr'20 6M: Jul'19 (Shell # 4) GT 1 1 2020

3M: Apr'20 6M: Jul'19 (Shell # 4) GT 1 1 2020
6M: Jul'20. Recipe will send by
GT 2 2 2021
May'2020.
6M: Jul'20. Recipe will send by
GT 1 2 2021
May'2020.
CCT 1 2 2021

6 M: Feb'20 GT 1 1 2020
6 M: Feb'20 GT 1 1 2020
6 M: Jul'20. Recipe will be sent on
GT 1 1 ### 2021
April, 2020

Development sample rec. on

GT 1 1 ### 2021
01.01.2020. Test not done.

Development work done. Now

waiting for raw material (API) (Mail
GT 1 1 2020
Sent on 5th Sep’19). 0.300 Kg API
Rec. on 21.01.20.
Lab Batchok. Concurrence will be
GT 1 1 2021
sent soon.
 GT 2 2 2021
GT 2 2 2022
GT 2 2 2022

Development sample of Clindamycin

phosphate is available. Retest date of
GT 2 2 2022
Benzoyl Proxide is Dec'19. Lab Batch
Not Done.

Pilot Batch will be done soon. GT 2 1 2021

Lab Batch oK.Concurrence sent. GT 2 2 2022

Lab batch manufacturing will be

GT 2 2 2022
done soon.

Lab batch manufacturing will be

GT 2 2 2022
done soon.

Lab batch manufacturing will be

GT 2 2 2021
done soon.

Development sample not available GT 2 2 2022

GT 2 2 2022

GT 2 2 2022
Sourcing ongoing for
AG 1 1 2021
another sample.
GT 2 2 2021
Preformulation study ongoing GT 3 3 2022
Preformulation study ongoing GT 2 2 2021
Preformulation study ongoing GT 2 2 2021
GT 3 3 2022
Development with commercial
GT 2 3 2022
material
GT 2 2 2022
GT 2 2 2022

GT 2 2 2022

GT 2 2 2022

GT 3 3 2022
 GT 3 3 2022

GT 3 3 2023

GT 3 3 2023

GT 3 3 2023

GT 3 3 2022

GT 3 3 2023

GT 3 3 2023

Line Extension. PMS Done. Stability

GT 1 1 2020
for Diluent will be start soon

Line Extension. PMS Done. Stability

GT 1 1 2020
for Diluent will be start soon
GT 3 3 2023
GT 3 3 2023
Lab batch manufacturing will be
GT 3 3 2023
done soon.

Lab batch manufacturing will be

GT 3 3 2023
done soon.

Lab Batch Done. Waiting for TRS. CC 1 1 2021

CC 1 1 2021
6 Month : July, 2020; Recipe: May,
CC 1 1 2021
2020
Lab Batch Done.Innovator Sample
CC 1 1 ### 2021
needed to set Dissolution profile.
Lab Batch Done.Innovator Sample
CC 1 1 ### 2021
needed to set Dissolution profile.
 6 Month : July, 2020; Recipe: Mar,
Not done CC 1 1 2020
2020
6 Month : July, 2020; Recipe: Mar,
CC 1 1 2020
2020
Lab batch done & waiting for TRS CC 1 1 ### 2021
Lab batch Not done CC 1 1 ### 2021
Lab batch done & waiting for TRS CC 2 2 2022
Lab batch done & waiting for TRS CC 2 2 2022
Lab Batch Done. Analysis of
Innovator product will be started CC 2 1 2021
25.01.2020
Lab Batch Done. Analysis of
Innovator product will be started CC 2 1 2021
25.01.2020
Lab Batch will be Done soon
.Innovator Sample needed to set CC 2 2 2021
Dissolution profile.
CC 2 2 2021

6 Month : June, 2020; Recipe: March, Recipe will sent to HO:

H 1 1 2020
2020 30.03.20
Lab Batch ok. Concurrence will be
H 2 2 2021
sent soon.
Req. sent on Sep'19 H 2 2 2021
Req. sent on Sep'19 H 1 1 2021

3M: 02-07-18
6M: 30-09-18
As per test result of Bioneeds, assay
result of two pilot batches (PBP/LM-
H 2 2 2021
010, PBP/LM-011) found satisfactory,
another pilot batch (PBP/LM-012)
result is out of specification. New
Pilot Batch Mfg. done on 26.12.19.

Pilot batch will be done soon H 2 2 2021

Annexure to be renewed. Pilot batch
H 2 2 2021
will be done soon
Pilot batch will be done soon H 2 2 2021

of Ophthalmic Products

Product
PD Status Regulatory Status
Group
Priority Updated Priority Proposed LY

Annexure done &

price done. Waiting for
6M: Ok (Toll Mfg.). Tube Shipment final packing for MA
OP 1 1 2020
done. Feb'20 Launching certificate.
Shade Card sent to
PD.
 Recipe approved DTL
sample submitted to
DGDA. pH related
6M: Ok (Toll Mfg.) document required OP 1 1 2020
from general pharma.
Inclusion is under
process.

Sent requisition OP 1 2 2022

req. sent on Aug, 2019. OP 1 1 ### 2021

Lab Batch sample given for analysis.

OP 1 2 2022
Waiting for correct Innovator sample

GMP source not found

req. sent on Aug, 2019. OP 2 2 2022
yet
New sample sent to
OP 2 1 2021
PD.
CS initiated and held
req. sent on Aug, 2019. OP 1 2 2021
up due to high price.
OP 1 1 2021

OP 2 2 2022

Product
PD Status Regulatory Status
Group
Priority Updated Priority Proposed LY

Requisition Sent on 23.09.19. COA

AG 1 1 ### 2021
rec. for Crystal on 15.01.20

Recipe will sent to HO:

AG 1 2 2021
29.02.20

1.0 kg PD sample received on

AG 1 1 ### 2021
02.01.20. lab Batch will be start soon.

100 ml Pk.- 6M:Apr’20. Recipe will be

sent within Feb, 2020 AG 1 1 2021
500 ml Pk.-6M:May’20

Lab batch to be done soon AG 1 1 ### 2021

Lab batch to be done soon AG 1 1 ### 2021

 - AG 1 2 2021

PD sample shipped on
Lab batch to be done soon AG 1 1 ### 2021
9th Dec’19.

AG 1 1 2021

AG 1 1 2021

NOC is under process. AG 1 1 2020

AG 1 1 2021

f Priority DCC Products

Product
PD Status Regulatory Status
Group
Priority Updated Priority Proposed LY

6M: Jun'20. Recipe send by march'20 GT 1 1 2021

Lab batch done & waiting for TRS GT 1 2 2022

6M: Jul''20. Recipe send by Apr'20 GT 1 1 2021

6M: Jul''20. Recipe send by Apr'20 GT 1 1 2021

Lab Batch trial continued for bitter
taste masking. New Exicipent GT 1 1 2021
required.
Recipe submitted-
Product OK GT 1 1 2021
(21.07.19)
6 M: May'20 Recipe send by 'May20 GT 1 1 2021
Recipe submitted-
Product OK GT 3 3 2023
(21.07.19)
Req. sent on Sep'19 GT 1 1 2021
Req. sent on Sep'19 GT 1 1 2021
Req. sent on Sep'19 GT 1 1 2021
4 months and 6 months analysis
done on due time. Only dissolution
PD will send recipe
of one batch sample from 40°C ± GT 3 3 2021
within 7th Feb'2020
75% RH condition done and result
found satisfactory on 30.05.2019
3 months and 6 months analysis
done on due time. Only dissolution
PD will send recipe
of one batch sample from 40°C ± GT 3 3 2021
within 4th Feb'2020
75% RH condition done and result
found satisfactory on 30.05.2019

Lab batch done & waiting for TRS GT 1 1 2021

6 M: Feb'20 GT 1 1 2020
GT 1 1 2022
GT 1 1 2022

GT 1 1 2021
PMD will launch
New Lab to be done. This product is Aspirin 81mg +
GT 2 3 2021
not urgently needed by PMD Omeprazole 40mg
Tablet.

GT 2 2 2021

New Proposal. GT 2 2 2022

Lab Batch ok. Concurrence OK. Pilot
GT 2 2 2023
Batch Mfg. running.

Lab batch manufacturing to be done Development needed

GT 2 2 2023
after finalization of Ilaprazole 5 tablet. urgently.

Lab batch manufacturing to be done

GT 2 2 2023
after finalization of Ilaprazole 5 tablet.
New Lab Batch To be done GT 2 2 2023
 GT 2 3 2023

GT 2 3 2023

GT 2 2 2021

6 M: Mar'20 GT 2 3 2023
6 M: Mar'20 GT 2 3 2023

New Proposal. GT 3 3 2023

5 months and 6 months analysis

done on due time. Only dissolution
Held up. Will not
of one batch sample from 40°C ± GT 3 3 2021
launch right now.
75% RH condition done and result
found satisfactory on 30.05.2019
Recipe rejected on
Product OK GT 3 3 2022
DCC-249

Recipe will be
Product OK submitted - DCC252 GT 3 3 ### 2023
(Rejected at DCC250)

6 M: May'20 Recipe send by 'May20 CC 1 1 2021

Lab Batch Done.Innovator Sample

CC 1 1 2021
needed to set Dissolution profile.

Lab batch sample given for Analysis CC 1 1 2021

Recipe rejected on
Product OK CC 1 2 2021
DCC-249

API Needed(Mail sent on 31st Oct’19) CC 2 2 2022

API Needed(Mail sent on 31st Oct’19) CC 2 2 2022

API Needed(Mail sent on 31st Oct’19) CC 2 2 2022

CTD Document to be done. Innovator

CC 2 2 2022
product needed.
CC 2 2 2022

CC 2 2 2022
CC 3 3 2022
CC 3 3 2022
CC 2 2 2022
CC 3 3 2022

6 M: Jun'20. Recipe will send by

H 1 1 2021
May'20
 Lab batch done on 21.01.2020 and
H 1 1 2021
TRS needed
6 M: December, 2019. H 3 3 2022

H 3 3 2022

H 3 3 2022

H 3 3 2022

H 3 3 2022

Recipe submitted-
Product OK OP 2 2 2022
(21.07.19)

OP 1 1 2021

on 2019 - 2020

Product
PD Status Regulatory Status
Group
Priority Updated Priority Proposed LY

CC 3 3 2023

GT 2 2 2022

GT 3 3 2023
GT 3 3 2023

GT 2 2 2022

GT 2 2 2022

GT 2 2 2022

GT 3 3 2023

GT 3 3 2023

GT 3 3 2023

GT 3 3 2023
GT 1 1 2021
GT 3 3 2023
GT 3 3 2023

GT 2 2 2022

CC 2 2 2021
CC 2 2 2021
CC 2 2 2022

AG 1 2021

AG 1 2021
AG 1 2021
GT 1 2021

GT 1 2021

GT 1 2021
GT 1 2021
GT 1 2021
GT 1 2021
 Remarks

Subjected to Narcotic approval

50000 IU Capsule will not be launched

50 mg will be launched after market feedback of 25 mg

capsule

Shape ok, New colored sample needed for concurrence

20 kg API received 6th Dec'18, Mfg. date 1st June 2018
& Exp. Date. 31st May'21
New Appratus (Turbid metric) needed around (33 lakh
taka), PD also evaluating another method with adding a
coloumn with potentiometer

Stability Problem

Levetiracetam 500 mg ER tablet will not be launched

This product will be launhed after the launching of
Levodopa + Carbidopa

Will be launched with Tamsulosin + Dutasteride

combination
Stability Problem
Will be launched with Amlodipine + Telmisertan
combination
Remarks
Remarks
 Finished product

Finished product

Finished product

Remarks
 Subjected to DCC approval

Subjected to DCC approval

Subjected to DCC approval

If any company received DCC approval, then it will be

1st priority product

If any company received DCC approval, then it will be

1st priority product

If any company received DCC approval, then it will be

1st priority product
Remarks
 New Product Status
SL. No. Product Name Or Dosage Form Proposal received QC Sample Status PD Material Status
Generic Name with Strength (With Shape, Size &
Color)

1 Amitriptyline 12.5 mg and Tablet Sep’17 Source approved. PD sample given

Chlordiazepoxide 5 mg tablet
2 Astaxanthin 2 mg Capsule Capsule Oct’18 Source approved. PD sample given
3 Astaxanthin 4 mg Capsule Capsule Oct’18 Source approved. PD sample given
4 Betahistine Dihydrochloride 16 mg Tablet Tablet July' 18 Source approved. PD sample given

5 Betahistine Dihydrochloride 8 mg Tablet Tablet July' 18 Source approved. PD sample given

6 Calcium Dobesilate 500 mg Capsule Capsule Jun'18 Source approved. PD sample given
7 Cholecalciferol 50,000 IU Tablet Tablet 43807 Source approved. PD sample given
8 Cholecalciferol BP 200,000 IU Injection Injection Jul/18 Source approved. PD sample given
9 Dantrolene Sodium 25 mg Capsule Capsule Oct’17 Source approved. PD sample given
10 Dantrolene Sodium 50 mg Capsule Capsule Oct’17 Source approved. PD sample given
11 Doxylamine Succinate USP 20 mg + ER Tablet Jun/18 Source approved. PD sample given
Pyridoxine Hydrochloride BP 20 mg
Tablet
12 Duloxetine; 20 mg, 30 mg Tablet Dec'19 Source approved. PD sample given
13 Ferric Pyrophosphate Citrate 5 ml Injection Source approved. PD sample given
14 Glucosamine 750 mg Tablet Nov'19 QC sample givem. N/A
Condroitin 600 mg Tablet Waiting for test
report.
15 Hydroquinone USP 4% + Fluocinolone Cream Aug'08 Source approved. PD sample given
BP 0.01% + Tretinoin BP 0.05% Cream

16 Jakloc 11 XR (Tofacitinib Citrate INN 11 XR Tablet Nov'17 Source approved. PD sample given
mg) Tablet
17 Levetiracetam 500 mg Tablet Oct'18 Source approved. PD sample given
18 Levetiracetam 500 mg/ 5 ml Oral Solution Oct'18 Source approved. PD sample given
19 Levodopa + Carbidopa; 250 Tablet Dec'19 Source approved. PD sample given
mg + 25 mg
20 Levodopa + Carbidopa; 100 Tablet Dec'19 Source approved. PD sample given
mg + 10 mg
21 Mirtazapine 15 mg Tablet Tablet Dec'20 Source approved. PD sample given
22 Mirtazapine 7.5 mg Tablet Tablet Dec'19 Source approved. PD sample given
23 Mupirocin 2% Ointment Ointment Sep/16 Source approved. PD sample given
24 Prucalopride Succinate INN 1mg Tablet Tablet Mar'19 Source approved. PD sample given

25 Prucalopride Succinate INN 2mg Tablet Tablet Mar'19 Source approved. PD sample given

26 Quetiapine Fumarate FC 100 mg Tablet Oct'18 Source approved. PD sample given

27 Quetiapine Fumarate FC 200 mg XR Tablet Oct'18 Source approved. PD sample given
28 Quetiapine Fumarate FC 25 mg Tablet Oct'18 Source approved. PD sample given
SL. No. Product Name Or Dosage Form Proposal received QC Sample Status PD Material Status
Generic Name with Strength (With Shape, Size &
Color)

29 Quetiapine Fumarate FC 50 mg XR Tablet Oct'18 Source approved. PD sample given

30 Rivastigmine Tartrate 1.5 Capsule Capsule Jun’18 Source approved. PD sample given
31 Rivastigmine Tartrate 3 Capsule Capsule Jun’18 Source approved. PD sample given
32 Safinamide 100 mg Tablet Tablet Jul’18 Source approved. PD sample given
33 Safinamide 50 mg Tablet Tablet Jul’18 Source approved. PD sample given
34 Sevelamer Carbonate 800 mg Tablet Tablet 43766 QC sample givem. One QC sample
Waiting for test rec. Waiting for
report. more sample.
35 Silodosin 4 mg capsule (#4) Capsule Jun'19 Source approved. PD sample given
36 Silodosin INN 8mg Capsule (#4) Capsule Jun'18 Source approved. PD sample given
37 Tamsulosin HCl USP 0.4mg Capsule ER Capsule Jul'18 Source approved. PD sample given
38 Tamsulosin Hydrochloride USP 0.4mg Capsule (SR+IR) Sep'18 Source approved. Development
mg + Dutasteride USP 0.5 mg IR sample received:
Capsule
39 Tolvaptan INN 15 mg Tablet Tablet Jul'18 Source approved. PD sample given
40 Triamcinolone 0.1% + Econazole 1% Cream 42639 Source approved. PD sample given
(Acetonide) Cream
41 Acetylcysteine 600 mg Effervescent tablet Dec’19 QC sample given.
Waiting for test
report.
42 Brivaracetam 25 mg Tablet Oct/18 Source approved. PD sample given
43 Brivaracetam 50 mg Tablet Oct/18 Source approved. PD sample given
44 Clindamycin Phosphate USP 1% + Gel in laminated Source approved. PD sample given
Benzoyl Peroxide USP 5% Gel, 25gm tube.
45 Ferric Carboxymaltose INN 100mg/2ml Injection Oct'17 Source approved. PD sample given
(500mg/10ml, 750mg/15ml,
1000mg/20ml vial)
46 Furosemide 40 mg + Spironolactone 50 Tablet Jun/18 Existing RM Existing RM
mg
47 Levodopa USP 100 + Carbidopa USP 20 Tablet Jul'18 Source approved. PD sample given
+ Entacapone USP 200mg Tablet
48 Levodopa USP 50 + Carbidopa USP Tablet Jul'18 Source approved. PD sample given
12.5 + Entacapone USP 200mg Tablet
49 Lidocaine Hydrochloride; 20 mg/ml Subcutaneous Dec’19 Existing RM Existing RM
solution (50 ml) Injection
50 Memantine HCl INN + Donepezil Hcl INN ER Capsule Jul'18 Source approved. Innovator product
is required for
setting dissolution
specification.
Requisition raised
on 12.10.2019 for
innovator.
Although
manufacturer has
been provided us
dissolution profile
with innovator’s
product.
SL. No. Product Name Or Dosage Form Proposal received QC Sample Status PD Material Status
Generic Name with Strength (With Shape, Size &
Color)

51 Memantine Hydrochloride 10 mg Tablet Jul'18 Source approved. PD sample given

52 Memantine Hydrochloride 5 mg Tablet Jul'18 Source approved. PD sample given
53 Menbutone 100mg/ml Injectable Solution Apr'19 1 QC sample given. 1 QC sample sent
Waiting for test to PD. Waiting for
report. another source.
54 Nitrofurantoin USP 100 mg SR Capsule Jun'18 QC sample givem.
Waiting for test
report.
55 Sodium Valporate 200mg CR Tablet Source approved. PD sample given
56 Sodium Valporate 200mg/ 5 ml Syrup Oct'18 Source approved. PD sample given
57 Sodium Valporate 300mg CR Tablet Source approved. PD sample given
58 Sodium Valporate 500mg CR Tablet Source approved. PD sample given
59 Tolvaptan INN 30 mg Tablet Tablet Jul'18 Source approved. PD sample given
60 Trihexyphenidyl 5 mg Tablet Dec'19 Source approved. PD sample given
61 Trihexyphenidyl 2 mg Tablet Dec'19 Source approved. PD sample given
62 Valbenazine INN 40mg Capsule Capsule Jul'18 1 QC sample given.
Waiting for test
report.
63 Valbenazine INN 80mg Capsule Capsule Jul'18 1 QC sample given.
Waiting for test
report.
64 Cranberry Extract 400 mg Capsule Jun/18 QC sample givem. Waiting for test
Waiting for test reagent
report.
65 Pentosan Polysulfate Sodium 100 mg Capsule Jun'18 QC sample givem. PMD informed via
Waiting for test Email, they are not
report. interested to buy
innovator's product
(1st time in BD),
due to high price.
Test not done.

66 Perampanel 2 mg Tablet Oct'18 QC sample givem. Two QC sample

Waiting for test received (18.12.18
report. & 25.02.19) from
same
manufacturer,
Waiting for another
sample.

67 Perampanel 4 mg Tablet Oct'18 QC sample givem. Two QC sample

Waiting for test received (18.12.18
report. & 25.02.19) from
same
manufacturer,
Waiting for another
sample.
SL. No. Product Name Or Dosage Form Proposal received QC Sample Status PD Material Status
Generic Name with Strength (With Shape, Size &
Color)

68 Pimavanserin Tartrate 17 mg Tablet Jul'18 QC sample givem. QC sample

Waiting for test received (14.02.19
report. & 28.09.19).
Waiting for source
approval &
document.

70 Tetrabenazine 12.5 mg Tablet Jul'18 Source approved.

Purchase held up
due to high price.
71 Tetrabenazine 25 mg Tablet Jul'18 Source approved.
Purchase held up
due to high price.
72 Vitamin B complex + Vitamin C; 10 ml lyophilized IV Nov' 19 Existing RM
vial with 100 ml 5% dextrose solution infusion
73 Vitamin B complex + Vitamin C; 10 ml lyophilized IV Nov' 19 Existing RM
vial with 100 ml normal saline infusion
74 Levetiracetam 250 mg Tablet Oct'18 Source approved. PD sample given.
75 Levetiracetam ER 750 mg ER Tablet Oct'18 Source approved. PD sample given
76 Levodopa USP 150 + Carbidopa USP Tablet Jul'18 Source approved. PD sample given
37.5 + Entacapone USP 200mg Tablet
77 Levodopa USP 200 + Carbidopa USP 50 Tablet Jul'18 Source approved. PD sample given
+ Entacapone USP 200mg Tablet

1 Amlodipine 5 mg + Telmisertan 40 mg Tablet Dec’18 Source approved PD sample given

Tablet
2 Amlodipine 5 mg + Telmisertan 80 mg Tablet Dec’18 Source approved PD sample given
Tablet
3 Telmisertan 40 mg Tablet Tablet Dec’18 Source approved Available
4 Metformin HCL BP 1000 mg+ Linagliptin ER Tablet 11/22/2017 Existing RM Available
INN 2.5 mg tablet
5 Metformin HCL BP 1000 mg+ Linagliptin ER Tablet 11/22/2017 Existing RM Available
INN 5mg tablet
6 Metformin HCL BP XR 1000mg tablet XR Tablet Jul'17 Existing RM Available
7 Metformin HCL BP XR 500mg tablet XR Tablet Jul'17 Existing RM Available
8 Prazosin 2.5 mg Tablet ER Tablet May’18 Source approved PD sample given
9 Prazosin 5 mg Tablet ER Tablet May’18 Source approved PD sample given
10 Gliclazide 30 mg MR Tablet MR Tablet Apr’18 Source approved PD sample given
11 Gliclazide 60 mg MR Tablet MR Tablet Apr’18 Source approved PD sample given
12 Metformin HCL BP 500mg + Glimepride SR Tablet Feb'16 Source approved PD sample given
USP 1 mg tablet
13 Metformin HCL BP 500mg + Glimepride SR Tablet Feb'16 Source approved PD sample given
USP 2 mg tablet
14 Ranolazine 1000 mg ER Tablet Jun/18 Source approved PD sample given
15 Ranolazine 500 mg ER Tablet Jun/18 Source approved PD sample given
SL. No. Product Name Or Dosage Form Proposal received QC Sample Status PD Material Status
Generic Name with Strength (With Shape, Size &
Color)

1 Coenzyme Q10 (Ubidecarenone USP) Capsule Not Available Source approved API Available.
100 mg Capsule EHGC Shell # 0
Selected
2 Desogestrel 0.075 mg Tablet Tablet May’19 Source approved PD sample given
3 Dienogest 2mg Tablet Tablet Apr’19 Source approved PD sample given
4 Elagolix Sodium 150mg Tablet Tablet Aug'18 Source approved PD sample given
5 FSH 150 IU Injection Lyo Injection Aug'17 Existing RM
6 HCG 10,000 IU Injection Lyo Injection Nov’19 Existing RM Available
7 HCG 2,500 IU Injection Lyo Injection Nov’19 Existing RM Available
8 HMG 150 IU Injection Lyo Injection Existing RM Available

Development Status of Ophthalmic Products

SL. No. Product Name Or Dosage Form Proposal received PD Material Status
Generic Name with Strength (With Shape, Size &
Color)

1 Hyprogel Eye Ointment (Hypromellose Eye Ointment Feb'17 Existing RM

(Hydroxypropyl Methylcellulose) Sterile
USP 0.300gm/100gm)
10gm Laminated tube
2 Lotenol Eye Ointment (Loteprednol Eye Ointment Ju'15 Existing RM
Etabonate (Micronized & Sterile) INN
0.500gm/100gm),
3gm Alu Tube
3 Netarsudil INN 0.02% Eye Drops Eye Drops May/18 Purchase held up
due to high price.
4 Travoprost USP 0.004% Ophthalmic Eye Drops Jun/18 Source approved PD sample given
Solution
5 Visin Plus Eye Drops (Glycerin Eye Drops Source approved PD sample given
USP0.2%, Hypromellose USP 0.36%,
PEG 400 USP 1%,TetrahydrozolineHCl
USP 0.05%, Zinc Sulphate USP 0.25%)

6 Netarsudil 0.02% + Latanoprost 0.005% Eye Drops May/19 Purchase held up

Ophthalmic Solution due to high price.
8 Lifitegrast INN 5% Eye Drops Sep'16 Purchase held up Source approved.
due to high price. Waiting for
Development
sample.

9 Moxifloxacin HCL 0.5% (5 gram in lami Eye Ointment May'17 Existing RM Available
tube)
10 Fluorometholone + Tetrahydrozoline Eye Drops Dec'18 Existing RM Available
(0.1% + 0.025%)
SL. No. Product Name Or Dosage Form Proposal received QC Sample Status PD Material Status
Generic Name with Strength (With Shape, Size &
Color)

SL. No. Product Name Or Dosage Form Proposal received PD Material Status
Generic Name with Strength (With Shape, Size &
Color)

1 Bromhexine HCl BP 20mg + Menthol BP Oral Solution Jan/19 Source approved PD sample given
44mg/ml Oral Solution
2 Ceftiofur HCl BP 50mg/ml Suspension Powder for Jan/19 Source approved PD sample given
(Cephalosporin) Suspension
3 Flunixine Meglumine USP 50mg/ml Injection Jan/19 Source approved PD sample given
Injection
4 Levofloxacin BP 100mg/ml Vet Oral Oral Solution May/19 Existing RM Available
Solution 100 ml & 500 ml
5 Meloxicam 100 mg Vet Bolus Bolus Source approved PD sample given
6 Meloxicam BP 50 mg/10ml Injection Injection Source approved PD sample given
7 Simethicone USP 10mg + Dill Oil BP Suspension 43481 Source approved PD sample given
0.005ml/ml Suspension
8 Tilmicosin Phosphate 250mg/ml Oral Solution Apr'19 Source approved PD sample given
9 Vitamin A, D3, B1, B2, B6, B12, B5, B3, Injection (Ready) 43788 Ready finished
Inositol, Methionin Choline Citrate, Mg product
Hypophosphate, Cobalt Chloride, Copper
Sulphate, Zinc Sulphate, Mangan
Sulphate
10 Bacillus Subtilis, Bacillus licheniformis, Oral Powder Nov'19 Ready finished
Bacillus mesentericus, Bacillus product
coagulans, Lactobacillus plantarum,
Lactobacillus acidophilus, pedilococcus
faecalis, Enterococcus faecium,
Saccharomyces, Beta-glucan,Mannan
oligosaccharides

11 Mastilok Oral Powder Ready finished As per

(Tri-Sodium citrate 25 gm, Vitamin A - product manufacturer
10000 IU, Vitamin D3- 2000 IU, Vitamin method sample
E- 800 mg, Vitamin H- 20 mg, Vitamin K- does not meet with
20 mg, Selenium- 4 mg, Potassium specification.
Iodide 4 mg, Copper Sulphate 960 mg,
Cobalt Sulphate 40 mg, Zn Sulphate 825
mg, Manganese Sulphate 3000 mg,
Lactic acid Bacillus 2000 M CFU, Live
Yeast 50000 M CFU, Serratopeptidase
32 mg, Bromelain 320 mg, Methionine
1500 mg, L-Lysine 3000 mg)/60gm
Sachet

12 Propylene glycol, Yest extract, Citric acid, Oral Liquid Nov' 19 Facility not available No QC sample
orthophosphoric acid, Lactic acid, available
Vitamin C, Vitamin E, DL-Methionine,
Megnesium sulphate, Betamine,
Mannitol, D-Sorbitol, Carrier.
SL. No. Product Name Or Dosage Form Proposal received QC Sample Status PD Material Status
Generic Name with Strength (With Shape, Size &
Color)

Development Status of Priority DCC Products

SL. No. Product Name Or Dosage Form Proposal received PD Material Status
Generic Name with Strength (With Shape, Size &
Color)

1 Bilastin 2.5mg/ml Syrup Syrup Sep’17 Source approved PD sample given

2 Calcoral DX with Vitamin K2 Capsule Oct’18 Source approved PD sample given
3 Cefixime 100 mg & Clavulanic Acid 62.5 Tablet Nov’13 Existing RM Available
mg per Tablet
4 Cefixime 200 mg & Clavulanic Acid 125 Tablet Nov’13 Existing RM Available
mg per Tablet
5 Cefixime 50 mg & Clavulanic Acid 31.25 PFS Jul’18 Existing RM Available
mg/5 ml PFS
6 Cefixime 500 mg/5ml PFS PFS Jun'17 Existing RM Available
7 Frovatriptan Succinate INN 2.5 mg Tablet Jul'19 Source approved PD sample given
(USFDA)
8 Itopride Hydrochoride 50 Tablet Tablet Jan’18 Source approved PD sample given
9 Lornoxicam 4 mg (EMA) Tablet May’19 Source approved PD sample given
10 Lornoxicam 8 mg (EMA) Tablet May’19 Source approved PD sample given
11 Lornoxicam 8 mg/2ml (EMA) Lyo Injection May’19 Source approved PD sample given
12 Pegalin INN 165mg Tablet ER Tablet Feb'17 Existing RM Available
13 Pegalin INN 82.5mg Tablet, ER Tablet Feb'17 Existing RM Available
14 Phenylephrine Injection 0.5 mg/ 5 ml Injection Oct’19 Existing RM Available
Ampoule
15 Sodium Chloride 600 mg tablet (Alu Alu Tablet Mar'19 Existing RM Available
Blister)
16 Tenapanor INN 50 mg (USFDA) Tablet Oct’19 Sourcing ongoing.
GMP compliance
source isnt
available.
17 Upadacitinib INN 15 (USFDA) mg ER Tablet Aug’19 Purchase held up
due to high price.
18 Fospropofol Disodium 35mg/ml (30 ml) Injection Sourcing ongoing.
(USFDA) GMP compliance
source isnt
available.
19 Aspirin BP 81mg + Omeprazole BP 40 Tablet Mar'17 Source approved PD sample given
mg delayed release tablet
20 Ferric Maltol 30mg Capsule Nov/19 QC sample given.
Waiting for test
report.
21 Glucosamine 1,500 mg Powder for Solution Dec’19 QC sample given.
Condroitin 1,200 mg (Sachet) Waiting for test
report.
22 Ilaprazole 5 Tablet Tablet Jun’17 Source approved PD sample given
23 Ilaprazole INN 10 mg Tablet Tablet Jun'17 Source approved PD sample given
SL. No. Product Name Or Dosage Form Proposal received QC Sample Status PD Material Status
Generic Name with Strength (With Shape, Size &
Color)

24 Ilaprazole INN 20 mg Tablet Tablet Jun'17 Source approved PD sample given

25 Itopride Hydrochoride 150 Tablet SR Tablet Jan’18 Source approved PD sample given
26 Memantine Hydrochloride 14 mg ER Capsule Jul'18 Source approved QC sample
received (13.10.19
& 23.09.19) test
running.

27 Memantine Hydrochloride 7 mg ER Capsule Jul'18 Source approved QC sample

received
(13.10.19 &
23.09.19)
Test running.
28 Sugammadex (as Sugammadex IV Injection Dec’19 QC sample given.
Sodium); 200 mg/2 ml Waiting for test
report.
29 Vonoprazon 10 mg Tablet Tablet May'18 Source approved PD sample given
30 Vonoprazon 20 mg Tablet Tablet May'18 Source approved PD sample given
31 Cefiderocol, 1 gm powder PFI Dec’19 Sourcing ongoing.
(Cephalosporin) GMP compliance
source isnt
available.
32 Pegalin INN 330mg Tablet ER Tablet Feb'17 Existing RM Available
33 Ebastine BP 10mg + Montelukast BP Tablet Existing RM Available
10mg
34 Rabigut PFI PFI (Lyo) Oct’17 Existing RM Available

1 Empagliflozin INN 10 mg + Linagliptin 5 Tablet Dec’ 18 Source approved PD sample given

mg (USFDA)
2 Empagliflozin INN 5 mg + Metformin HCl ER Tablet Nov’ 18 Source approved PD sample given
BP 1000 mg (USFDA)
3 Empagliflozin INN 5 mg + Metformin HCl Tablet Nov’ 18 Source approved PD sample given
BP 500 mg (USFDA)
4 Gliclazide BP 80 mg + Metformin BP 500 Tablet Jan'16 Source approved Available
mg tablet
5 Benidipine HCL INN 2 mg tablet Tablet Apr’18 Source approved PD sample given
6 Benidipine HCL INN 4 mg tablet Tablet Apr’18 Source approved PD sample given
7 Benidipine HCL INN 8mg Tablet Tablet Apr'18 Source approved PD sample given
8 Bisoprolol 5 + Amlodipine 5 Tablet Tablet Oct’11 Existing RM Available
9 Omarigliptin 12.5 mg Tablet Tablet Jul’18 Source approved.
Purchase held up
due to high price.

10 Omarigliptin 25 mg Tablet Tablet Jul’18

11 Semaglutide 14mgTablet Tablet Sep/19 Purchase held up
12 Semaglutide 3mg Tablet Tablet Sep/19 due to high price.
13 Semaglutide 7mg Tablet Tablet 43735
SL. No. Product Name Or Dosage Form Proposal received QC Sample Status PD Material Status
Generic Name with Strength (With Shape, Size &
Color)

14 Sotagliflozin 200 mg Tbalet Tablet Nov/19 QC sample given.

Waiting for test
report.

1 Hydroxyprogesterone Caproate (HPC) Injection Nov’19 Existing RM Available

Injection 500mg/2 ml
2 Natural Micronized Progesterone INN SR Tablet May/19 Source approved PD sample given
200 mg Tablet
3 Natural Micronized Progesterone INN SR Tablet Jan/18 Source approved PD sample given
300 mg Tablet
4 Corifollitropin alfa, 100 Micrograms of Injection (Liquid) Oct' 18 Sourcing running
Corifollitropin alfa in 0.5 ml solution
5 Corifollitropin alfa, 150 Micrograms of Injection (Liquid) Oct' 18 Sourcing running
Corifollitropin alfa in 0.5 ml solution
6 FSH (Follitropin alfa) (Recombinant) INN Lyo Injection Aug'17 Source approved
100 IU
7 L-carnitine INN 340 mg +Ubidecarenone FC Tablet Dec’19 Existing RM
BP 50 mg + Elemental Zinc INN 5 mg +
Lycopene USP 2.5 mg + Astaxanthin INN
8 mg tablet (Fertility Supplement)

1 Naphazoline 0.03% and Hypromellose Eye Drops Jun'17 Source approved PD sample given
0.5% Ophthalmic Suspension
2 Carboxymethylcellulose Sodium + Eye Drops Sep'18 Existing RM Available
Glycerin (0.5% + 0.9%)

New Proposal Received on 2019 - 2020

SL. No. Product Name Or Dosage Form Proposal received PD Material Status
Generic Name with Strength (With Shape, Size &
Color)

1 Sevelamer Carbonate 400 mg Tablet Tablet 43766 QC sample given.

Waiting for test
report.
2 Isotretinoin 0.05% Gel Gel Sep/16 Source approved PD sample given
3 Lasmiditan 50 mg Tablet Tablet Nov/19 QC sample given.
Waiting for test
report.
4 Lasmiditan 100 mg Tablet Tablet Nov/19
5 Lefamulin (as Lefamulin Acetate) 600 mg Tablet 43751 Purchase held up
Tablet due to high price.
6 Lefamulin (as Lefamulin Acetate) 150 mg Injection 43751
Injection
7 Patiromer (as Patiromer Sorbitex PFS 43766 QC sample given.
Calcium) 8.4 gm PFS in Sachet Waiting for test
report.
SL. No. Product Name Or Dosage Form Proposal received QC Sample Status PD Material Status
Generic Name with Strength (With Shape, Size &
Color) QC sample given.
Waiting for test
8 Patiromer (as Patiromer Sorbitex PFS Oct/19 report.
Calcium) 16.8 gm PFS in Sachet
9 Patiromer (as Patiromer Sorbitex PFS Oct/19
Calcium) 25.2 gm PFS in Sachet
10 Fosfomycin Trometamol 3 gm Granules Granules for Oral Sep/18 QC sample given.
for Oral Solution Solution (Sachet) Waiting for test
11 Obeticholic Acid 25 mg Tablet Tablet Dec/19 report.
12 Domperidone 5mg/ml (15ml) Paediatric Drops 43843 Source approved
13 Famotidine 20 mg Tablet 43837 Source approved PD sample given
14 Famotidine 40 mg Tablet 43837 Source approved PD sample given
15 Famotidine 10 mg + Calcium Carbonate Chewable Tablet Jan/20 Source approved PD sample given
800 mg + Magnesium Hydroxide 165 mg

16 Rivaroxaban 2.5 mg Tablet 43843 QC sample given.

Waiting for test
report.
17 Rivaroxaban 10 mg Tablet 43843 QC sample given.
Waiting for test
report.
18 Ticagrelor 90 mg Tablet Jan/20 QC sample given.
Waiting for test
report.
19 Sulfadiazine + Neomycin Sulphate (150 Oral Suspension Jul/20 QC sample given.
mg + 25 mg per ml) Waiting for test
report.
20 Marbofloxacin 50 mg Tablet Jul/20 QC sample given.
Waiting for test
report.
21 Marbofloxacin 100 mg Injection Jul/20 QC sample given.
Waiting for test
report.
22 Colecalciferol 1000 IU per 5 ml Syrup Jul/20 Source approved PD sample given
23 Fusidic acid + Hydrocortisone acetate Cream Mar/20 Source approved PD sample given
(2% + 1%)
24 Esketamine HCL 25 mg per ml Injection Aug/20 Source approved
25 Voriconazole 200 mg Tablet Apr/20 Source approved PD sample given
26 Nabumetone 500 mg Tablet Jan/20 Source approved PD sample given
27 Nabumetone 750 mg Tablet Jan/20 Source approved PD sample given