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 CAS-1197-18-8 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-1197-18-8, including repackagers and relabelers. The FDA regulates CAS-1197-18-8 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-1197-18-8 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 CAS-1197-18-8 supplier is an individual or a company that provides CAS-1197-18-8 active pharmaceutical ingredient (API) or CAS-1197-18-8 finished formulations upon request. The CAS-1197-18-8 suppliers may include CAS-1197-18-8 API manufacturers, exporters, distributors and traders.
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A CAS-1197-18-8 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-1197-18-8 active pharmaceutical ingredient (API) in detail. Different forms of CAS-1197-18-8 DMFs exist exist since differing nations have different regulations, such as CAS-1197-18-8 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CAS-1197-18-8 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-1197-18-8 USDMF includes data on CAS-1197-18-8's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-1197-18-8 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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