Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
01 2Malladi Drugs & Pharmaceuticals Limited
02 1Avon Organics Limited
03 1Catalytica
04 1Cheng Fong Chemical Co., Ltd
05 1Chifeng Arker Pharmaceutical Technology Co. Ltd.
06 3EURAND
07 1Embio Limited
08 4F. Hoffmann-La Roche
09 2Krebs Biochemicals & Industries Ltd
10 2Lycored
11 1Mallinckrodt Pharmaceuticals
12 1Xinjiang Heshuo Ephedrine Product Co., Ltd
13 5Blank
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2516
Submission : 1975-08-28
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 : 2014-03-25
Pay. Date : 2014-03-14
DMF Number : 10320
Submission : 1993-06-24
Status :
Type : II
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A Pseudoephedrine, (+)- manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pseudoephedrine, (+)-, including repackagers and relabelers. The FDA regulates Pseudoephedrine, (+)- manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pseudoephedrine, (+)- 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 Pseudoephedrine, (+)- supplier is an individual or a company that provides Pseudoephedrine, (+)- active pharmaceutical ingredient (API) or Pseudoephedrine, (+)- finished formulations upon request. The Pseudoephedrine, (+)- suppliers may include Pseudoephedrine, (+)- API manufacturers, exporters, distributors and traders.
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A Pseudoephedrine, (+)- DMF (Drug Master File) is a document detailing the whole manufacturing process of Pseudoephedrine, (+)- active pharmaceutical ingredient (API) in detail. Different forms of Pseudoephedrine, (+)- DMFs exist exist since differing nations have different regulations, such as Pseudoephedrine, (+)- USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pseudoephedrine, (+)- DMF submitted to regulatory agencies in the US is known as a USDMF. Pseudoephedrine, (+)- USDMF includes data on Pseudoephedrine, (+)-'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pseudoephedrine, (+)- USDMF is kept confidential to protect the manufacturer’s intellectual property.
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