Aspen API. More than just an API™
01 1Aspen API
02 1Apicore
03 1Auro Peptides Limited
04 1BCN Peptides
05 1Chengdu Shengnuo Biopharm
06 1Hybio Pharmaceutical
07 1Sun Pharmaceutical Industries Limited
08 2Blank
Aspen API. More than just an API™
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-07
Pay. Date : 2024-03-05
DMF Number : 13971
Submission : 1999-02-04
Status :
Type : II
89
PharmaCompass offers a list of Ganirelix API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ganirelix manufacturer or Ganirelix supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ganirelix manufacturer or Ganirelix supplier.
PharmaCompass also assists you with knowing the Ganirelix API Price utilized in the formulation of products. Ganirelix API Price is not always fixed or binding as the Ganirelix Price is obtained through a variety of data sources. The Ganirelix Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ganirelix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ganirelix, including repackagers and relabelers. The FDA regulates Ganirelix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ganirelix 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 Ganirelix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ganirelix supplier is an individual or a company that provides Ganirelix active pharmaceutical ingredient (API) or Ganirelix finished formulations upon request. The Ganirelix suppliers may include Ganirelix API manufacturers, exporters, distributors and traders.
click here to find a list of Ganirelix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ganirelix DMF (Drug Master File) is a document detailing the whole manufacturing process of Ganirelix active pharmaceutical ingredient (API) in detail. Different forms of Ganirelix DMFs exist exist since differing nations have different regulations, such as Ganirelix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ganirelix DMF submitted to regulatory agencies in the US is known as a USDMF. Ganirelix USDMF includes data on Ganirelix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ganirelix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ganirelix suppliers with USDMF on PharmaCompass.
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