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Food & Drugs Administration (Maharashtra State)

Letter No: MH/AZ2/FSC/6099533


Food & Drugs Administration, AURANGABAD Division
Office of the Joint Commissioner,
2nd floor, Nath Super Market, Aurangpura
Aurangabad

FREE SALE CERTIFICATE CERTIFICATE No : 6099533


Dt : 17/05/2021

This is to certify that M/s. 710530- IPCA LABORATORIES LIMITED, H-4,MIDC,, WALUJ,,
AURANGABAD - 431136, Dist: AURANGABAD ZONE 2, is holding drug/cosmetic manufacturing
Licence in Form No.25 bearing No.
25-AD/070 (Iss Dt: 16/12/2005, Ren Dt: 01/04/2019, Val Dt: 31/03/2024)

, issued by this Administration under the provisions of the Drugs & Cosmetics Act, 1940 and Rules thereunder.
Under the said Licence, the manufacturer is permitted to manufacture following products as mentioned below.

Prod Name of Drugs


1. Aceclofenac (Acelofenacum) Ph.Eur Domestic (Ph. Eur.)
472964 - -- (- )
2. Aceclofenac BP Domestic (BP)
472962 - -- (- )
3. Aceclofenac IP Domestic (IP)
472960 - -- (- )
4. Allopurinol (Allopurinolum) Ph.Eur. Export (Ph. Eur.)
472829 - -- (- )
5. Allopurinol (Allopurinolum) Ph.Eur. Domestic (Ph. Eur.)
472966 - -- (- )
6. Allopurinol BP Export (BP)
472830 - (- )
7. Allopurinol BP Domestic (BP)
472967 - -- (- )
8. Allopurinol IP Domestic (IP)
472965 - -- (- )
9. Allopurinol USP Export (USP)
472834 - -- (- )
10. Atenolol (Atenololum) Ph.Eur. Export (Ph. Eur.)
472835 - -- (- )
11. Atenolol (Atenololum) Ph.Eur. Domestic (Ph. Eur.)
472973 - -- (- )
12. Atenolol BP Export (BP)
472836 - -- (- )
13. Atenolol BP Domestic (BP)
472974 - -- (- )
14. Atenolol IP Domestic (IP)
472972 - -- (- )
15. Atenolol USP Export (USP)
472839 - (- )
16. Atenolol USP Domestic (USP)
472977 - -- (- )
17. Chlortalidone BP Export (BP)
472869 - -- (- )
18. Chlortalidone BP Domestic (BP)
473010 - -- (- )
19. Chlortalidone IP Domestic (IP)
473016 - -- (- )
20. Chlortalidone JPC Export
472875 - -- (- )
21. Chlortalidone JPC Domestic
473015 - -- (- )
22. Chlortalidone Ph.Eur. Export (Ph. Eur.)
472871 - -- (- )
23. Chlortalidone Ph.Eur. Domestic (Ph. Eur.)
473011 - -- (- )
24. Chlortalidone USP Export (USP)

Fee Payment(s) : DB-Id: 390268 - 07/05/2021 (Amt: 2000) (Free Sale Certification application) Balance : 11250
This License/Certificate is eSIGNED. Physical Signature is NOT Required
Division MFG File No Type:Free Sale Certificate CERTIFICATE No Issue Dt / Validity Dt
AURANGABAD (AZ2) 710530 FSC-171373-07/05/2021 6099533 17/05/2021 - 16/05/2022
For online Third Party Approval Verification;Go to fdamfg.maharashtra.gov.in & Click TPAV Pg: 1 / 3 (17/05/21) N I C
button.
472872 - -- (- )
25. Chlortalidone USP Domestic (USP)
473012 - -- (- )
26. Flumequine (Flumequinum) Export (Ph. Eur.)
472897 - -- (- )
27. Flumequine (Flumequinum) Domestic (Ph. Eur.)
473035 - -- (- )
28. Flumequine BP Export (BP)
472895 - -- (- )
29. Flumequine BP Domestic (BP)
473034 - -- (- )
30. Lumefantrine CP Export (CP)
472858 - -- (- )
31. Lumefantrine PhI Export (PhI)
472859 - -- (- )
32. Lumefantrine PhI Domestic (PhI)
473000 - -- (- )
33. Metformin Hydrochloride BP Export (BP)
472876 - -- (- )
34. Metformin Hydrochloride BP Domestic (BP)
473017 - -- (- )
35. Metformin Hydrochloride IP Domestic (IP)
473023 - -- (- )
36. Metformin Hydrochloride Ph.Eur. Export (Ph. Eur.)
472877 - -- (- )
37. Metformin Hydrochloride Ph.Eur. Domestic (Ph. Eur.)
473018 - -- (- )
38. Metformin Hydrochloride USP Export (USP)
472878 - -- (- )
39. Metformin Hydrochloride USP Domestic (USP)
473019 - -- (- )
40. -/ OXANTEL PAMOATE /- Export (IHS(In House))
737882 -:
41. OXANTEL PAMOATE /- Domestic (IHS(In House))
737884 -:
42. Piperaquine Phosphate Export
472887 - -- (- )
43. PIPERAQUINE PHOSPHATE /- Domestic (IHS(In House))
737977 -:
44. Propranolol Hydrochloride (Propranololi Hydrochloridum) Ph.Eur. Domestic (Ph. Eur.)
472985 - -- (- )
45. Propranolol Hydrochloride BP Domestic (BP)
472986 - (- )
46. Propranolol Hydrochloride IP Domestic (IP)
472984 - -- (- )
47. Pyrantel Embonate BP Export (BP)
472899 - -- (- )
48. Pyrantel Embonate BP Domestic (BP)
473036 - -- (- )
49. Pyrantel Embonate Ph.Eur. Export (Ph. Eur.)
472901 - -- (- )
50. Pyrantel Embonate Ph.Eur. Domestic (Ph. Eur.)
473037 - -- (- )
51. Pyrantel Embonate PhI Export (PhI)
472906 - -- (- )
52. Pyrantel Embonate PhI Domestic (PhI)
473041 - -- (- )
53. Pyrantel Pamoate IP Domestic (IP)
473040 - -- (- )
54. Pyrantel Pamoate USP Export (USP)
472905 - -- (- )
55. Pyrantel Pamoate USP Domestic (USP)
473039 - -- (- )

The Above Products are Freely Sold in India, Similar Products are also Freely Sold in India, This Certificate is issued for Export
Registration
This Certificate is Valid for a period : 17/05/2021 - 16/05/2022
Additional Para: Free sale certificate for CEP, Korean and Taiwan customers
Department Para: CEP/Ph. Eur./Korean and Vietnam customers.

Fee Payment(s) : DB-Id: 390268 - 07/05/2021 (Amt: 2000) (Free Sale Certification application) Balance : 11250
This License/Certificate is eSIGNED. Physical Signature is NOT Required
Division MFG File No Type:Free Sale Certificate CERTIFICATE No Issue Dt / Validity Dt
AURANGABAD (AZ2) 710530 FSC-171373-07/05/2021 6099533 17/05/2021 - 16/05/2022
For online Third Party Approval Verification;Go to fdamfg.maharashtra.gov.in & Click TPAV Pg: 2 / 3 (17/05/21) N I C
button.
SANJAY SHANKAR KALE S. S. KALE
e-Signed on 17-05-2021 05:59 Licensing Authority
Food & Drugs Administration
TPAV # P11U212NE3 AURANGABAD Division, Maharashtra State

Submission at: Phu Thai Material Company Ltd. , District, Hanoi City, Vietnam., Phu Thai Material Company Ltd. Add : No.16,
Vietnam - Russia Tropical Centre Dormitory, Co nhue 1 Ward, Bac Tu Liem District, Hanoi City, Vietnam.(CEP /Ph. Eur. for
Export customers. Europe and Korean customers.)

Fee Payment(s) : DB-Id: 390268 - 07/05/2021 (Amt: 2000) (Free Sale Certification application) Balance : 11250
This License/Certificate is eSIGNED. Physical Signature is NOT Required
Division MFG File No Type:Free Sale Certificate CERTIFICATE No Issue Dt / Validity Dt
AURANGABAD (AZ2) 710530 FSC-171373-07/05/2021 6099533 17/05/2021 - 16/05/2022
For online Third Party Approval Verification;Go to fdamfg.maharashtra.gov.in & Click TPAV Pg: 3 / 3 (17/05/21) N I C
button.

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