01 1Orpharma
02 1Blank
01 1LEVO-ALPHA-ACETYLMETHADOL (LAAM)-PRODUCED FOR NAT'L INST. DRUG ABUSE
02 1LEVOMETHADYL ACETATE HYDROCHLORIDE (LAAM HCL)
01 1Australia
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12741
Submission : 1997-10-10
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3760
Submission : 1980-04-03
Status : Inactive
Type : II
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A Laam Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Laam Hydrochloride, including repackagers and relabelers. The FDA regulates Laam Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Laam 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 Laam Hydrochloride supplier is an individual or a company that provides Laam Hydrochloride active pharmaceutical ingredient (API) or Laam Hydrochloride finished formulations upon request. The Laam Hydrochloride suppliers may include Laam Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Laam Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Laam Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Laam Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Laam Hydrochloride DMFs exist exist since differing nations have different regulations, such as Laam Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Laam Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Laam Hydrochloride USDMF includes data on Laam Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Laam Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Laam Hydrochloride suppliers with USDMF on PharmaCompass.
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