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 1MSN Laboratories
04 1Viatris
01 3SINCALIDE
02 1Sincalide
01 2India
02 1Switzerland
03 1U.S.A
01 4Active
01 1Complete
02 3Blank
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
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-09
Pay. Date : 2022-10-25
DMF Number : 36429
Submission : 2021-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32302
Submission : 2018-01-07
Status : Active
Type : II
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.
click here to find a list of Sincalide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
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.
click here to find a list of Sincalide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sincalide DMF (Drug Master File) is a document detailing the whole manufacturing process of Sincalide active pharmaceutical ingredient (API) in detail. Different forms of Sincalide DMFs exist exist since differing nations have different regulations, such as Sincalide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sincalide DMF submitted to regulatory agencies in the US is known as a USDMF. Sincalide USDMF includes data on Sincalide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sincalide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sincalide suppliers with USDMF on PharmaCompass.
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