Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Mehta API
03 1Mehta Pharmaceutical Industries
04 1Trifarma
01 3India
02 1Italy
01 2Active
02 2Blank
01 4Blank
01 4Blank
01 1WC-0214
02 3Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-22
Pay. Date : 2017-06-05
DMF Number : 31496
Submission : 2017-05-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19890
Submission : 2006-06-02
Status : Active
Type : II
NDC Package Code : 46204-0007
Start Marketing Date : 2012-05-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2020-02-14
Valid Till : 2022-07-02
Written Confirmation Number : WC-0214
Address of the Firm :
A Stemetil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Stemetil, including repackagers and relabelers. The FDA regulates Stemetil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Stemetil 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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