Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
01 1Malladi Drugs & Pharmaceuticals Limited
02 1Supriya Lifescience
03 2F. Hoffmann-La Roche
04 1FUKUZYU PHARMACEUTICAL CO LTD
05 2GSK
06 1Keshava Organics
07 1Kongo Chemical Co., Ltd.
08 1Merck & Co
09 2Sandoz B2B
10 1Tris Pharma Inc
11 1Blank
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 : 33944
Submission : 2019-08-14
Status :
Type : II
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-18
Pay. Date : 2015-05-08
DMF Number : 22210
Submission : 2008-11-13
Status :
Type : II
A Chlorpheniramine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlorpheniramine Maleate, including repackagers and relabelers. The FDA regulates Chlorpheniramine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlorpheniramine Maleate 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 Chlorpheniramine Maleate supplier is an individual or a company that provides Chlorpheniramine Maleate active pharmaceutical ingredient (API) or Chlorpheniramine Maleate finished formulations upon request. The Chlorpheniramine Maleate suppliers may include Chlorpheniramine Maleate API manufacturers, exporters, distributors and traders.
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A Chlorpheniramine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Chlorpheniramine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Chlorpheniramine Maleate DMFs exist exist since differing nations have different regulations, such as Chlorpheniramine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chlorpheniramine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Chlorpheniramine Maleate USDMF includes data on Chlorpheniramine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chlorpheniramine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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