01 1PolyPeptide Group
02 1Blank
01 1ANTOCIN
02 1ATOSIBAN ACETATE
01 1Switzerland
02 1Blank
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7574
Submission : 1988-07-06
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39950
Submission : 2024-05-29
Status : Active
Type : II
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PharmaCompass offers a list of Atosiban API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Atosiban manufacturer or Atosiban supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Atosiban manufacturer or Atosiban supplier.
A Atosiban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atosiban, including repackagers and relabelers. The FDA regulates Atosiban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atosiban 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 Atosiban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Atosiban supplier is an individual or a company that provides Atosiban active pharmaceutical ingredient (API) or Atosiban finished formulations upon request. The Atosiban suppliers may include Atosiban API manufacturers, exporters, distributors and traders.
click here to find a list of Atosiban suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Atosiban DMF (Drug Master File) is a document detailing the whole manufacturing process of Atosiban active pharmaceutical ingredient (API) in detail. Different forms of Atosiban DMFs exist exist since differing nations have different regulations, such as Atosiban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Atosiban DMF submitted to regulatory agencies in the US is known as a USDMF. Atosiban USDMF includes data on Atosiban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atosiban USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Atosiban suppliers with USDMF on PharmaCompass.
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