01 1Chemische Fabrik Berg
02 1Malladi Drugs & Pharmaceuticals Limited
03 1Cambrex Corporation
04 1Cody Laboratories, Inc.
05 1Gyma Laboratories of America
06 1Olon S.p.A
07 1Pisgah Labs
08 1Siegfried AG
09 1Symed Labs
10 1Zydus Lifesciences
11 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-27
Pay. Date : 2014-08-20
DMF Number : 15442
Submission : 2001-05-14
Status :
Type : II
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2025-03-05
Pay. Date : 2025-02-06
DMF Number : 38657
Submission : 2023-11-08
Status :
Type : II
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A Benzeneethanamine, alpha,alpha-dimethyl, hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzeneethanamine, alpha,alpha-dimethyl, hydrochloride, including repackagers and relabelers. The FDA regulates Benzeneethanamine, alpha,alpha-dimethyl, hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzeneethanamine, alpha,alpha-dimethyl, 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.
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A Benzeneethanamine, alpha,alpha-dimethyl, hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzeneethanamine, alpha,alpha-dimethyl, hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Benzeneethanamine, alpha,alpha-dimethyl, hydrochloride DMFs exist exist since differing nations have different regulations, such as Benzeneethanamine, alpha,alpha-dimethyl, hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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