01 2Bristol Myers Squibb
01 1HETACILLIN
02 1HETACILLIN ACID
01 2U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13427
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13422
Submission : 1998-09-01
Status : Inactive
Type : II
A Hetacillin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hetacillin, including repackagers and relabelers. The FDA regulates Hetacillin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hetacillin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Hetacillin supplier is an individual or a company that provides Hetacillin active pharmaceutical ingredient (API) or Hetacillin finished formulations upon request. The Hetacillin suppliers may include Hetacillin API manufacturers, exporters, distributors and traders.
click here to find a list of Hetacillin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hetacillin DMF (Drug Master File) is a document detailing the whole manufacturing process of Hetacillin active pharmaceutical ingredient (API) in detail. Different forms of Hetacillin DMFs exist exist since differing nations have different regulations, such as Hetacillin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hetacillin DMF submitted to regulatory agencies in the US is known as a USDMF. Hetacillin USDMF includes data on Hetacillin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hetacillin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hetacillin suppliers with USDMF on PharmaCompass.
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