Minakem is manufacturing small molecules APIs including corticosteroids
01 1Minakem (formerly Delmar Chemicals)
02 1Sanofi
03 1Bracco
04 1Calyx Chemicals & Pharmaceuticals Limited
05 1Macleods Pharmaceuticals Limited
06 1Viatris
07 1Blank
01 5PYRAZINAMIDE
02 2PYRAZINAMIDE USP
01 1Canada
02 1France
03 2India
04 1Italy
05 1U.S.A
06 1Blank
01 4Active
02 3Inactive
01 2Complete
02 5Blank
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15325
Submission : 2001-02-28
Status : Active
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14623
Submission : 1999-12-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5909
Submission : 1985-06-27
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-30
Pay. Date : 2015-10-15
DMF Number : 15553
Submission : 2001-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-21
Pay. Date : 2016-08-24
DMF Number : 30448
Submission : 2016-05-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34229
Submission : 2019-11-01
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8604
Submission : 1990-06-20
Status : Inactive
Type : II
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A Pyrazinamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pyrazinamide, including repackagers and relabelers. The FDA regulates Pyrazinamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pyrazinamide 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 Pyrazinamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pyrazinamide supplier is an individual or a company that provides Pyrazinamide active pharmaceutical ingredient (API) or Pyrazinamide finished formulations upon request. The Pyrazinamide suppliers may include Pyrazinamide API manufacturers, exporters, distributors and traders.
click here to find a list of Pyrazinamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pyrazinamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Pyrazinamide active pharmaceutical ingredient (API) in detail. Different forms of Pyrazinamide DMFs exist exist since differing nations have different regulations, such as Pyrazinamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pyrazinamide DMF submitted to regulatory agencies in the US is known as a USDMF. Pyrazinamide USDMF includes data on Pyrazinamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pyrazinamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pyrazinamide suppliers with USDMF on PharmaCompass.
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