01 1Jiangsu Hengrui Medicine
01 1SHR0302 NON-STERILE BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33027
Submission : 2018-08-21
Status : Active
Type : II
A Ivarmacitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ivarmacitinib, including repackagers and relabelers. The FDA regulates Ivarmacitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ivarmacitinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Ivarmacitinib supplier is an individual or a company that provides Ivarmacitinib active pharmaceutical ingredient (API) or Ivarmacitinib finished formulations upon request. The Ivarmacitinib suppliers may include Ivarmacitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Ivarmacitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ivarmacitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Ivarmacitinib active pharmaceutical ingredient (API) in detail. Different forms of Ivarmacitinib DMFs exist exist since differing nations have different regulations, such as Ivarmacitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ivarmacitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Ivarmacitinib USDMF includes data on Ivarmacitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ivarmacitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ivarmacitinib suppliers with USDMF on PharmaCompass.
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