1 Name and address of M/s Wenovo Pharmaceuticals Plot #31,32 Punjab

manufacturer/Applicant small Industrial estate, Taxila , Pakistan

Brand Name+ Dosage form + strength
Composition
Diary No. Date of R & I & fee
Empaglflozin 10 mg Tablet
Each Film Coated Tablet Contains:
Empagliflozin……….10 mg(Wenovo Specs)
Dy. No._______ dated _______ , Fee Rs:
_________dated _______vide deposit slip
No.________.

Pharmacological Group Antidiabetic (sodium-glucose co-transporter 2

(SGLT2) inhibitors)
Type of Form Form 5D
Finished Product Specification Wenovo Specifications
Pack Size and Demanded Price 2×7s
Approval status of Product in Reference Empagliflozin 10 mg film coated tablets(USFDA
Regulator Authorities Approved)
Me too Status Empaa 10 mg Tablet manufactured by Horizon
Pharmaceuticals, Lahore
GMP Status GMP certificate issued based upon inspection
conducted in 14-06-2022
Remark of the Evaluator
STABILTY STUDY DATA
Manufacturer Of API (Empagliflozin) M/s Huainan Shunlong
Pharmaceuticals co .,Ltd No. 9th Yongxing Road,
Huainan Economic and Technological Development
zone, Huainan city, China.
API Lot No. 20190325
Description of Pack Alu-Alu blister packed in unit carton
(Container Closure System)
Stability Storage Condition Real Time: 30°C ± 2°C /65% ± 5 RH
Accelerated: 40°C ± 2°C /75% ± 5 RH
Time Period Real Time: 24 months
Accelerated: 6 months
Frequency Real Time: 0,3,6,9,12,18,24 (months)
Accelerated: 0,3,6 (months)
Batch No. T-004 T-005 T-006
Batch Size 2000 Tablets 2000 Tablets 2000 Tablets
Manufacturing date 07-2020 07-2020 07-2020
Date of Initiation 22-07-2020 22-07-2020 22-07-2020
No. of Batches 03
Date of Submission
DOCUMENTS/DATA PROVIDED BY THE APPLICANT
Sr. No Documents to be provided Status
1 Reference of previous approval of The firm has referred to previous inspection for
applications with stability studies data of authenticity of stability data of their products
the firm. conducted by the panel, on the basis of which
Registration Board in its 297th meeting dated 12-15

2 Certificate of Analysis of API from both
API manufacturer and finished product
manufacturer.
3. Method used for Analysis of API from
both API manufacturer and finished
product manufacturer
4. Stability study data of API from API
manufacturer
5. Approval of API/ DML/GMP Certificate of
API manufacturer issued by concerned
regulatory authority of country of origin
6. Documents for the procurement of API
with approval from DRAP(in case of
import)
7. Protocols followed for conduction of
stability study
8. Method used for analysis of FPP
9. Drug-Excipients compatibility studies
(where applicable)
january,2021, decided to approve registration of
A Tablets 10mg.
Inspection date: 14-10-2018.
The report shows that:
Finished Pharmaceutical Product stability testing
was conducted on was conducted on HPLC R&D
19 for A tablet which were 21 CFR 21 compliant
for initial 6 months.
Adequate monitoring and control were available
for stability chamber.
1. Copy of COA (Batch# 20190325) of API
(Empagliflozin) from M/s Huainan Shunlong
Pharmaceuticals co .,Ltd No. 9th Yongxing Road,
Huainan Economic and Technological Development
zone, Huainan city, China. are submitted.
Methods used for analysis of API from both API
Manufacturers and Finished Product Manufacturer
are provided by the firm.
Empagliflozin: Firm has submitted stability study
data of API as per zone IV-A. Stability study is
conducted at Real time conditions; 30 °C ± 2 °C /
65% ± 5%RH for 24 months and at Accelerated
conditions; 40 °C±2°C/75%±5%RH for 6 months at
intervals 0, 3, 6, 9, 12, 18, 24 & 0, 1, 2, 3 ,4 & 6
months respectively. Batches:() 10 days stress
stability study at conditions60 °C ± 2 °C, Photolysis
4500 ±500LXand92.5%± 5%RH at 0, 5 th & 10 th
days intervals also provided
Firm has submitted copy of GMP certificate dated
24-08-2020 in the name of M/s Huainan Shunlong
Pharmaceuticals co .,Ltd No. 9th Yongxing Road,
Huainan Economic and Technological Development
zone, Huainan city, China . Valid till 23-08-2023.
The firm has submitted copy of invoice No. HN200-
Hdated03-06-2018 from exporter M/s Beijing Sino
Hanson Import & Export Col, Ltd. No.3, Zhonghe
road, Fengtai District, Beijing China, for import of
1kgs of Empagliflozin(Batch No. L-E-2029-D01-E06-
01) in name of M/sABC Pharmaceuticals Private
Ltd. Lahore attested by AD (I&E) DRAP
Lahoredated18-06-2018
Submitted
Submitted
Drug excipients compatibility study performed
10. Complete Batch manufacturing Record The firm has submitted Batch Manufacturing
of three stability batches record of following03Batches:
Batch No. Batch Size Mfg. Date
T-004 2000 Tablets 07-2020
T-005 2000 Tablets 07-2020
T-006 2000 Tablets 07-2020

11. Record of Comparative dissolution Provided Comparative dissolution was performed

data(where applicable) against Empaa 10 mg tablet BatchNo.641 in HCl
buffer (pH 1.2), Acetate buffer(pH 4.5) &
Phosphate buffer (pH6.8)
12. Data of 03 Batches will be supported by Submitted
attested respective documents like
chromatograms, Raw data sheets, COA,
Summary Data Sheets Etc
13. Compliance Record of HPLC software 21 Submitted
CFR & audit trail reports on product
testing
14. Record of digital data logger for Submitted
temperature and humidity monitoring of
stability chamber(Real Time and
Accelerated)
REMARKS OF EVALUATOR

Decision: