Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Apicore LLC
03 1IRIX Manufacturing Inc.
04 1Raks Pharma
05 1Suven Life Sciences Limited
01 4METYROSINE USP
02 1METYROSINE, USP
01 4India
02 1U.S.A
01 4Active
02 1Inactive
01 3Complete
02 2Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-13
Pay. Date : 2017-12-22
DMF Number : 32336
Submission : 2017-12-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37364
Submission : 2022-09-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16099
Submission : 2002-08-15
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-09
Pay. Date : 2019-05-14
DMF Number : 33862
Submission : 2019-06-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-08
Pay. Date : 2020-03-19
DMF Number : 34329
Submission : 2020-02-04
Status : Active
Type : II
A METYROSINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of METYROSINE, including repackagers and relabelers. The FDA regulates METYROSINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. METYROSINE 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 METYROSINE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A METYROSINE supplier is an individual or a company that provides METYROSINE active pharmaceutical ingredient (API) or METYROSINE finished formulations upon request. The METYROSINE suppliers may include METYROSINE API manufacturers, exporters, distributors and traders.
click here to find a list of METYROSINE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A METYROSINE DMF (Drug Master File) is a document detailing the whole manufacturing process of METYROSINE active pharmaceutical ingredient (API) in detail. Different forms of METYROSINE DMFs exist exist since differing nations have different regulations, such as METYROSINE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A METYROSINE DMF submitted to regulatory agencies in the US is known as a USDMF. METYROSINE USDMF includes data on METYROSINE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The METYROSINE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of METYROSINE suppliers with USDMF on PharmaCompass.
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