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
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A Chlor-trimeton 12 hour manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlor-trimeton 12 hour, including repackagers and relabelers. The FDA regulates Chlor-trimeton 12 hour manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlor-trimeton 12 hour 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 Chlor-trimeton 12 hour supplier is an individual or a company that provides Chlor-trimeton 12 hour active pharmaceutical ingredient (API) or Chlor-trimeton 12 hour finished formulations upon request. The Chlor-trimeton 12 hour suppliers may include Chlor-trimeton 12 hour API manufacturers, exporters, distributors and traders.
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A Chlor-trimeton 12 hour DMF (Drug Master File) is a document detailing the whole manufacturing process of Chlor-trimeton 12 hour active pharmaceutical ingredient (API) in detail. Different forms of Chlor-trimeton 12 hour DMFs exist exist since differing nations have different regulations, such as Chlor-trimeton 12 hour USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chlor-trimeton 12 hour DMF submitted to regulatory agencies in the US is known as a USDMF. Chlor-trimeton 12 hour USDMF includes data on Chlor-trimeton 12 hour's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chlor-trimeton 12 hour USDMF is kept confidential to protect the manufacturer’s intellectual property.
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