Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Bachem AG
03 1Rochem International Inc
04 1Azico Biophore India Pvt. Ltd
05 1MSN Laboratories
06 1Shenzhen JYMed Technology
07 1Viatris
01 1China
02 3India
03 1Switzerland
04 2U.S.A
01 4Active
02 3Blank
01 7Blank
01 7Blank
01 1WC-0404A3
02 6Blank
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 : 34202
Submission : 2019-12-17
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15165
Submission : 2000-11-27
Status : Active
Type : II
NDC Package Code : 55463-0004
Start Marketing Date : 1999-10-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32302
Submission : 2018-01-07
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-09
Pay. Date : 2022-10-25
DMF Number : 36429
Submission : 2021-10-30
Status : Active
Type : II
NDC Package Code : 69766-102
Start Marketing Date : 2021-10-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2021-02-26
Valid Till : 2023-06-22
Written Confirmation Number : WC-0404A3
Address of the Firm :
NDC Package Code : 69575-4029
Start Marketing Date : 2018-12-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1000g/1000g)
Marketing Category : BULK INGREDIENT
A Sincalide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sincalide, including repackagers and relabelers. The FDA regulates Sincalide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sincalide 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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A Sincalide supplier is an individual or a company that provides Sincalide active pharmaceutical ingredient (API) or Sincalide finished formulations upon request. The Sincalide suppliers may include Sincalide API manufacturers, exporters, distributors and traders.
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