Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
01 1Malladi Drugs & Pharmaceuticals Limited
02 1Ami Lifesciences Private Limited
03 1ALP Pharm
04 1Asahi Kasei Finechem
05 1CMIC CMO CO
06 1Daiichi Sankyo
07 1Hunan Dongting Pharmaceutical Co., Ltd.
08 1Kyowa Pharma Chemical Co Ltd
09 2Pfizer Inc
10 2Shilpa Medicare
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 : 37130
Submission : 2022-07-29
Status :
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-13
Pay. Date : 2023-11-01
DMF Number : 36336
Submission : 2021-10-07
Status :
Type : II
A Exacyl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Exacyl, including repackagers and relabelers. The FDA regulates Exacyl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Exacyl 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 Exacyl supplier is an individual or a company that provides Exacyl active pharmaceutical ingredient (API) or Exacyl finished formulations upon request. The Exacyl suppliers may include Exacyl API manufacturers, exporters, distributors and traders.
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A Exacyl DMF (Drug Master File) is a document detailing the whole manufacturing process of Exacyl active pharmaceutical ingredient (API) in detail. Different forms of Exacyl DMFs exist exist since differing nations have different regulations, such as Exacyl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Exacyl DMF submitted to regulatory agencies in the US is known as a USDMF. Exacyl USDMF includes data on Exacyl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Exacyl USDMF is kept confidential to protect the manufacturer’s intellectual property.
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