Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Alembic Pharmaceuticals Limited
03 1Unipex
01 1France
02 2India
01 2Active
02 1Blank
01 3Blank
01 3Blank
01 1WC-0082
02 2Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37010
Submission : 2022-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35367
Submission : 2020-11-30
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
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A Tegaserod manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tegaserod, including repackagers and relabelers. The FDA regulates Tegaserod manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tegaserod 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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