Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Capital Farma
03 1Bayer AG
04 1Grupo Juste
05 1JRC
06 2Vasudha Pharma Chem
07 1Xian Libang Pharmaceutical Co.,Ltd
01 1China
02 1Germany
03 4India
04 2Spain
01 2Active
02 2Inactive
03 4Blank
01 2Valid
02 6Blank
01 8Blank
01 1WC-0183A3-4
02 1WC-0183nA2
03 6Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Certificate Number : CEP 2017-186 - Rev 01
Issue Date : 2024-08-05
Type : Chemical
Substance Number : 873
Status : Valid
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32735
Submission : 2018-07-23
Status : Active
Type : II
Date of Issue : 2022-06-15
Valid Till : 2025-07-14
Written Confirmation Number : WC-0183nA2
Address of the Firm :
NDC Package Code : 66577-030
Start Marketing Date : 2018-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-28
Pay. Date : 2013-11-25
DMF Number : 4973
Submission : 1983-04-07
Status : Active
Type : II
Certificate Number : R1-CEP 1999-181 - Rev 03
Issue Date : 2018-02-28
Type : Chemical
Substance Number : 873
Status : Valid
NDC Package Code : 52134-0500
Start Marketing Date : 2009-08-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1015
Submission : 1966-12-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18325
Submission : 2005-04-15
Status : Inactive
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0183A3-4
Address of the Firm :
NDC Package Code : 66577-030
Start Marketing Date : 2018-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Diatrizoic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diatrizoic Acid, including repackagers and relabelers. The FDA regulates Diatrizoic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diatrizoic Acid 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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