Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Lusochimica
03 1Midas Pharma
04 1Shouyuan Chemical
05 1Sionc Pharmaceuticals
06 1Tianish Laboratories
07 1Viatris
01 1China
02 1Germany
03 3India
04 1Italy
05 1U.S.A
01 1Inactive
02 6Blank
01 7Blank
01 7Blank
01 1WC-0117
02 1WC-0273
03 5Blank
01 1269-1-ND
02 6Blank
01 7Blank
01 7Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22032
Submission : 2008-09-25
Status : Inactive
Type : II
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
Date of Issue : 2023-11-15
Valid Till : 2026-05-11
Written Confirmation Number : WC-0273
Address of the Firm :
Registrant Name : Menarini Korea Co., Ltd.
Registration Date : 2004-05-03
Registration Number : 269-1-ND
Manufacturer Name : Lusochimica SpA_x000D_ _x000D_
Manufacturer Address : La Vettola Pisa (PI) - via Livornese 897
19
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A Zoprace (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zoprace (TN), including repackagers and relabelers. The FDA regulates Zoprace (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zoprace (TN) API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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