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