Aspen API. More than just an API.
01 1Aspen API
02 1Apicore LLC
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
A Ganirelix Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ganirelix Acetate, including repackagers and relabelers. The FDA regulates Ganirelix Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ganirelix Acetate 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 Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ganirelix Acetate supplier is an individual or a company that provides Ganirelix Acetate active pharmaceutical ingredient (API) or Ganirelix Acetate finished formulations upon request. The Ganirelix Acetate suppliers may include Ganirelix Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Ganirelix Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ganirelix Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ganirelix Acetate active pharmaceutical ingredient (API) in detail. Different forms of Ganirelix Acetate DMFs exist exist since differing nations have different regulations, such as Ganirelix Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ganirelix Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Ganirelix Acetate USDMF includes data on Ganirelix Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ganirelix Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ganirelix Acetate suppliers with USDMF on PharmaCompass.
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