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