01 1Bayer AG
02 1Bristol Myers Squibb
03 1Calyx Chemicals & Pharmaceuticals Limited
04 1SIGMA TAU
05 1Yangzhou Pharmaceutical
06 1Yuki Gosei Kogyo
07 1Blank
01 2ISONIAZID
02 1ISONIAZID (NEOTEBEN)
03 1ISONIAZID BULK FORM
04 1ISONIAZID USP23
05 1ISONICOTINIC ACID HYDRAZIDE
06 1NYDRAZID
01 1China
02 1Germany
03 1India
04 1Japan
05 2U.S.A
06 1Blank
01 3Active
02 4Inactive
01 2Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5890
Submission : 1985-06-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 89
Submission : 1979-04-04
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-14
Pay. Date : 2015-09-30
DMF Number : 21322
Submission : 2008-02-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7689
Submission : 1988-09-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16235
Submission : 2002-11-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-17
Pay. Date : 2014-06-04
DMF Number : 4772
Submission : 1982-12-07
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14662
Submission : 2000-01-10
Status : Inactive
Type : II
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Corporate PDF
A Isoniazid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoniazid, including repackagers and relabelers. The FDA regulates Isoniazid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoniazid 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 Isoniazid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isoniazid supplier is an individual or a company that provides Isoniazid active pharmaceutical ingredient (API) or Isoniazid finished formulations upon request. The Isoniazid suppliers may include Isoniazid API manufacturers, exporters, distributors and traders.
click here to find a list of Isoniazid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isoniazid DMF (Drug Master File) is a document detailing the whole manufacturing process of Isoniazid active pharmaceutical ingredient (API) in detail. Different forms of Isoniazid DMFs exist exist since differing nations have different regulations, such as Isoniazid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isoniazid DMF submitted to regulatory agencies in the US is known as a USDMF. Isoniazid USDMF includes data on Isoniazid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isoniazid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isoniazid suppliers with USDMF on PharmaCompass.
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