Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Asymchem Laboratories
03 1Dipharma
04 1Dipharma SA
05 1HONOUR LAB LTD
06 1Innopharmax
07 1Shiratori Pharmaceutical
08 1Solara Active Pharma Sciences
01 1SAPROPTERIN
02 5SAPROPTERIN DIHYDROCHLORIDE
03 1SAPROPTERIN DIHYDROCHLORIDE (NEW PROCESS)
04 1SAPROPTERIN HYDROCHLORIDE DRUG SUBSTANCE
01 1China
02 3India
03 1Italy
04 1Japan
05 1Switzerland
06 1Taiwan
01 7Active
02 1Inactive
01 6Complete
02 2Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-18
Pay. Date : 2021-09-28
DMF Number : 36147
Submission : 2021-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28416
Submission : 2014-06-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-04
Pay. Date : 2013-09-23
DMF Number : 26682
Submission : 2012-12-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-26
Pay. Date : 2020-06-15
DMF Number : 34926
Submission : 2020-06-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-20
Pay. Date : 2019-07-26
DMF Number : 33928
Submission : 2019-08-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-06-23
Pay. Date : 2019-03-22
DMF Number : 33553
Submission : 2019-02-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17569
Submission : 2004-07-20
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-03-13
Pay. Date : 2019-12-13
DMF Number : 34185
Submission : 2019-10-03
Status : Active
Type : II
A Sapropterin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sapropterin, including repackagers and relabelers. The FDA regulates Sapropterin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sapropterin 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 Sapropterin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sapropterin supplier is an individual or a company that provides Sapropterin active pharmaceutical ingredient (API) or Sapropterin finished formulations upon request. The Sapropterin suppliers may include Sapropterin API manufacturers, exporters, distributors and traders.
click here to find a list of Sapropterin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sapropterin DMF (Drug Master File) is a document detailing the whole manufacturing process of Sapropterin active pharmaceutical ingredient (API) in detail. Different forms of Sapropterin DMFs exist exist since differing nations have different regulations, such as Sapropterin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sapropterin DMF submitted to regulatory agencies in the US is known as a USDMF. Sapropterin USDMF includes data on Sapropterin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sapropterin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sapropterin suppliers with USDMF on PharmaCompass.
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