01 1Boehringer Ingelheim GmbH
01 1LEVO-ALPHA-ACETYL-METHADOL (LAAM) HYDROCHLORIDE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15038
Submission : 2000-09-14
Status : Inactive
Type : II
A Methadol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methadol Hydrochloride, including repackagers and relabelers. The FDA regulates Methadol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methadol 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 Methadol Hydrochloride supplier is an individual or a company that provides Methadol Hydrochloride active pharmaceutical ingredient (API) or Methadol Hydrochloride finished formulations upon request. The Methadol Hydrochloride suppliers may include Methadol Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Methadol Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methadol Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Methadol Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Methadol Hydrochloride DMFs exist exist since differing nations have different regulations, such as Methadol Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methadol Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Methadol Hydrochloride USDMF includes data on Methadol Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methadol Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methadol Hydrochloride suppliers with USDMF on PharmaCompass.
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