Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Transo-Pharm Handels GmbH
03 1ACIC Fine Chemicals
04 2Cambrex Corporation
05 1Hetero Drugs
06 1Lupin Ltd
07 1Maithri Drugs
08 1Recordati
09 1Blank
01 1Germany
02 4India
03 1Italy
04 3U.S.A
05 1Blank
01 7Active
02 1Inactive
03 2Blank
01 10Blank
01 1225MF10146
02 1305MF10033
03 8Blank
01 10Blank
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 : 37094
Submission : 2022-06-01
Status : Active
Type : II
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9619
Submission : 1992-09-30
Status : Active
Type : II
Registration Number : 225MF10146
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2013-07-25
Latest Date of Registration : --
NDC Package Code : 12828-0068
Start Marketing Date : 1993-02-22
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 : 27574
Submission : 2013-07-25
Status : Active
Type : II
NDC Package Code : 12828-0068
Start Marketing Date : 1993-02-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-05-26
Pay. Date : 2013-09-06
DMF Number : 26816
Submission : 2013-09-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-23
Pay. Date : 2019-09-12
DMF Number : 32668
Submission : 2018-04-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38209
Submission : 2023-04-17
Status : Active
Type : II
Registration Number : 305MF10033
Registrant's Address : VIA M. Civitali, 1-20148 MILANO, ITALY
Initial Date of Registration : 2023-03-15
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35758
Submission : 2021-03-29
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7405
Submission : 1988-03-26
Status : Inactive
Type : II
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A Cysteamine Bitartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cysteamine Bitartrate, including repackagers and relabelers. The FDA regulates Cysteamine Bitartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cysteamine Bitartrate 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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