USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
01 1USV Private Limited
02 1Auro Peptides Limited
03 1MSN Laboratories
01 3ETELCALCETIDE HYDROCHLORIDE
01 3India
01 3Active
01 3Complete
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-07
Pay. Date : 2021-03-24
DMF Number : 35768
Submission : 2021-07-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-11
Pay. Date : 2020-11-12
DMF Number : 35386
Submission : 2020-11-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-23
Pay. Date : 2020-09-01
DMF Number : 35097
Submission : 2020-09-01
Status : Active
Type : II
A Etelcalcetide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etelcalcetide, including repackagers and relabelers. The FDA regulates Etelcalcetide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etelcalcetide 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 Etelcalcetide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Etelcalcetide supplier is an individual or a company that provides Etelcalcetide active pharmaceutical ingredient (API) or Etelcalcetide finished formulations upon request. The Etelcalcetide suppliers may include Etelcalcetide API manufacturers, exporters, distributors and traders.
click here to find a list of Etelcalcetide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Etelcalcetide DMF (Drug Master File) is a document detailing the whole manufacturing process of Etelcalcetide active pharmaceutical ingredient (API) in detail. Different forms of Etelcalcetide DMFs exist exist since differing nations have different regulations, such as Etelcalcetide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Etelcalcetide DMF submitted to regulatory agencies in the US is known as a USDMF. Etelcalcetide USDMF includes data on Etelcalcetide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Etelcalcetide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Etelcalcetide suppliers with USDMF on PharmaCompass.
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