EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
02 1Ami Lifesciences Private Limited
03 1Apothecon Pharmaceuticals
04 1Aurobindo Pharma Limited
05 1CHEMO IBERICA SA
06 1CTX Lifesciences
07 1Derivados Quimicos SAU
08 2Emcure Pharmaceuticals
09 1Formosa Laboratories
10 1Hetero Drugs
11 1Lupin Ltd
12 1Solara Active Pharma Sciences
13 1Sun Pharmaceutical Industries Limited
14 1The Dow Chemical Company
15 1Viatris
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-20
Pay. Date : 2023-09-18
DMF Number : 38198
Submission : 2023-06-27
Status :
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38016
Submission : 2023-03-01
Status :
Type : II
A Sevelamer Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sevelamer Hydrochloride, including repackagers and relabelers. The FDA regulates Sevelamer Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sevelamer Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sevelamer Hydrochloride supplier is an individual or a company that provides Sevelamer Hydrochloride active pharmaceutical ingredient (API) or Sevelamer Hydrochloride finished formulations upon request. The Sevelamer Hydrochloride suppliers may include Sevelamer Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sevelamer Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sevelamer Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sevelamer Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Sevelamer Hydrochloride DMFs exist exist since differing nations have different regulations, such as Sevelamer Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sevelamer Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Sevelamer Hydrochloride USDMF includes data on Sevelamer Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sevelamer Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sevelamer Hydrochloride suppliers with USDMF on PharmaCompass.
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