Proposed Planning for R & D at

Requirements and Capabilities

1
 R&D Centre: Scope of Work

 Formulation development of Dosage forms targeting , Nepal

Market, WHO Market, US Market, Europe Market and ROW
Market.
 Implementing advance technologies using cost effective
methods
 Identifying critical life saving drugs and developing a generic
version which can be afforded by all
 R & D to become an individual organization with the ability
to generate its own revenue (Monetized) by preparing
Dossiers for US and Europe market and Selling them to
organizations who outsource their development work or buy
approved dossiers from other organization.
 R & D will do development for in-house projects as well as
work as CRO for other organizations.
Dosage forms to be developed at R & D
 R & D to execute complete Product life cycle support from formulation
development to scale- up and commercialization for the following
dosage forms.
 Oral Dosage Form
 Immediate-release dosage form
 Delayed release dosage forms
 Sustained/extended/controlled/prolonged release dosage forms
 Powder dosage form
 Multi-unit particulate dosage forms
 Osmotic Dosage form
 Chrono-modulated dosage form
 Soft Gelatin capsules
 Solution dosage form
 Suspension dosage form
 Sustained release suspension dosage form
 Film Dosage form
 Parenteral Dosage forms
 DPI & MDIs
 Drugs requiring NTI acceptance criteria for Bio studies.
 Formulation development of drugs requiring in vitro characterizations
and in vitro bio studies.
3
 General Information

 Funding will be first required for Oral and Parenteral projects

which can start immediately (Details of funding utilization in
subsequent slides)
 Funding for MDIs projects will be required after 8 to 10 months
(Details of funding utilization in subsequent slides)
 Return of investment will come from exporting the projects in
ROW market for DJPL and also by selling dossiers to other
organizations (CRO)
 For CROs any project developed in R & D will require
approximately 50000 USD up to the pilot bio stage.
 The price for dossier for critical projects in Eu is 100000 USD
and 180000 USD for US projects.
 The same dossier can be sold in multiple markets as well.
 The same dossier can be filed as DJPL product in multiple
markets and it will keep on generating revenues.
 R & D can develop 15 projects for Eu and US market upto pilot
bio stage per year with the propsed infrastructure in this PPT
 For the MDIs The Global industry was valued as 16.3 billion in
2021, it is projected to reach more than 22.1 billion by 2031.
 We will have to give a rough market estimate for MDIs in Nepal
here
 List of Equipment Required for Solid product development
S.
N Name of Equipment for Formulation Quantity Price in USD
o
1 Weighing balance (4 digit) 1 250
2 Weighing balance (3 digit) 1 250
3 Weighing balance (2 digit) 3 1000
4 Moisture analyser 1 1700
5 Bin Cone Blender (With Changeable Bowl 5L ,10 L & 15 L) 1 25000
6 RMG (with 3L, 5L,10 L bowl) 2 50,000
7 Top spray Granulator 1 2500
8 FBD (with change parts of 5 KG & 15 KG bowl) 2 50,000
9 Wurster Coater (GPCG 1.1 for pellet coating) 2 187,500
10 Multi-mill (With 4 different screen) 2 16875
11 Compression machine single layered 3 375000
12 Compression machine bilayer 1 18750
13 Compression machine tablet in Tablet 1 28750
14 Compression machine for MUPS 1 28750
15 Coating Pan with interchangeable bowls 2 25000
16 Friability tester 1 700
17 Hardness tester 1 2615
18 Disintegration apparatus 1 1300
19 Screw gauge 1 100
20 Vernier calliper 1 100
21 Capsule filling machine with different change plate 1 75000
22 aluminium Pouch sealing machine 1 100
23 LDPE bag sealing machine 1 500
24 Induction sealing machine 1 1000
25 Air compressor 1 1000
26 Stability chamber 4 37500
27 Photostability chamber 1 5000
28 Crimping machine 1 5000
Total price 94120
 List of Equipment's for injectable project development

S.
N Name of Equipment for Formulation Quantity Price in USD
o
1 Pressure Vessel 3L & 5 L (2 no) 2 5000
2 Over Head Stirrer 2 1000
3 Hot Plate Magnetic Stirrer 2 1000
4 Recirculating Cooler 1 500
5 Peristaltic pump (Masterflex) 1 500
6 Oxybaby 2 7000
7 WiFi Temprature Probe 2 250
8 Micro Log Pro II (Data Logger) 2 500
9 Orion VERSA STAR Meter 1 5000
10 Autoclave 1 1000
11 Integrity tester 1 13000
12 Viscometer 1 7000
13 Stirrer 1 (2 no) 2 500
14 pH Meter 1 1000
15 Refrigerator 1 1000
16 Dry heat sterilizer 1 1300
17 Electronic balance 1 250
18 Milli Q 1 33000
19 Laminar Air flow 1 5000
Total 83800
 List of Instruments for Analysis of Oral and Parenteral projects

S.
N Name of instruments required for analysis Quantity Price in USD
o
1 HPLC with UV detector 4 125000
2 HPLC with PDA detector 2 75000
3 HPLC with UV detector & RI detector 2 85000
4 5-digit Analytical balance with printer 1 500
5 5-digit Analytical balancer 1 400
6 pH meter 1 1000
7 Dissolution - Auto Sample 4 8000
8 Gas chromatography 1 500000
9 Sonicator 1 500
10 Wrist action shaker 1 500
11 Dissolution apparatus (Manual) 2 2000
12 Dissolution apparatus (Manual) 2 2000
13 UV spectrphotometer 1 7000
14 Hot Air Oven 1 1000
15 Glasswares 1 5000
16 Cloumns for HPLC 1 10000
Total 372900

7
 List Of Equipment & Instruments for Development of MDIs

S.
N Name of instruments required for analysis Quantity Price in USD
o
1 Blendor 2 24000
2 Blister filling machine 1 1250000
3 HPLC (H class) 2 85000
4 Polarimeter 1 3750
5 Gas chromatography 1 500000
6 Malvern particle size analyser 1 90000
7 Karl fischer equipment 1 15000
8 Dynamic vapour sorption 1 17000
9 UV spectrphotometer 1 7000
10 Mikron device assembly machine 1 125000
DPI Flow Test Fixture Assembly 1
11 12500
12 CMM vision system 1 3000
13 Drop indicator 1 1000
14 Optical comparator 1 12000
15 Sound level meter 1 1000
Mecmesin Torque tester 1
16 22000
IEC 60068-2-64 Vibration and shock instrument 1
17 1000
18 LC MS 1 30000
19 Dosage Unit sampling apparatus 1 10000
20 Critical flow controller 1 1000
Next Generation Impactor (NGI) 1
21 7000
22 Anderson Cascade Impactor (ACI) 1 9000
 List Of Equipment & Instruments for Development of MDIs

S.
N Name of instruments required for analysis Quantity Price in USD
o
Light Microscope with 10X eye piece and 20X Objective 1
23 2500
24 FTIR 1 17000
25 DUSA shaker 1 1000
26 Micromeritics (Model Tristar 3000) 1 800
Total 2247550
 Total funding required for all Machinery's and instruments

S.
N Name of instruments required for analysis Quantity Price in USD
o
Machinery’s for solid ORals 1 94120
1
Machinery’s for Parentrals 1 83800
2
Instruments for Analytical 1 372900
3
Machinery’s and instruments for DPIs & MDIs 1 2247550
4
Total 2798370

Note: The above cost is required for infrastructure for R &D, Apart from
this there will be Over head costs, Manpower costs & RM and PM costs
which will vary from project to project.