01 1Emnar Pharma
01 1(S)-(+)-2-AMINOBUTYRAMIDE HYDROCHLORIDE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34120
Submission : 2019-12-11
Status : Active
Type : II
A S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE, including repackagers and relabelers. The FDA regulates S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE 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 S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE supplier is an individual or a company that provides S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE active pharmaceutical ingredient (API) or S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE finished formulations upon request. The S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE suppliers may include S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE API manufacturers, exporters, distributors and traders.
click here to find a list of S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE DMF (Drug Master File) is a document detailing the whole manufacturing process of S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE active pharmaceutical ingredient (API) in detail. Different forms of S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE DMFs exist exist since differing nations have different regulations, such as S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE DMF submitted to regulatory agencies in the US is known as a USDMF. S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE USDMF includes data on S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of S(+)-2-AMINOBUTANAMIDE HYDROCHLORIDE suppliers with USDMF on PharmaCompass.
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