AMI Lifesciences is Driven by Chemistry. Powered by People.
01 1Ami Lifesciences Private Limited
02 1Apothecon Pharmaceuticals
03 1Aurobindo Pharma Limited
04 2CHEMO IBERICA SA
05 1CTX Lifesciences
06 3Emcure Pharmaceuticals
07 2Formosa Laboratories
08 2Hetero Drugs
09 1Lupin Ltd
10 1Shandong Xinhua Pharmaceutical
11 1Solara Active Pharma Sciences
12 1Sun Pharmaceutical Industries Limited
13 1Viatris
14 1Waterstone Pharmaceuticals Inc.
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37981
Submission : 2023-01-25
Status :
Type : II
A Sevelamer Carbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sevelamer Carbonate, including repackagers and relabelers. The FDA regulates Sevelamer Carbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sevelamer Carbonate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Sevelamer Carbonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sevelamer Carbonate supplier is an individual or a company that provides Sevelamer Carbonate active pharmaceutical ingredient (API) or Sevelamer Carbonate finished formulations upon request. The Sevelamer Carbonate suppliers may include Sevelamer Carbonate API manufacturers, exporters, distributors and traders.
click here to find a list of Sevelamer Carbonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sevelamer Carbonate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sevelamer Carbonate active pharmaceutical ingredient (API) in detail. Different forms of Sevelamer Carbonate DMFs exist exist since differing nations have different regulations, such as Sevelamer Carbonate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sevelamer Carbonate DMF submitted to regulatory agencies in the US is known as a USDMF. Sevelamer Carbonate USDMF includes data on Sevelamer Carbonate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sevelamer Carbonate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sevelamer Carbonate suppliers with USDMF on PharmaCompass.
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