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 1Blank
01 1GANIRELIX
02 6GANIRELIX ACETATE
03 1GANIRELIX ACETATE NON-STERILE BULK DRUG SUBSTANCE
01 2China
02 3India
03 1Netherlands
04 1Spain
05 1Blank
01 8Active
01 5Complete
02 3Blank
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 : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36902
Submission : 2022-04-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-30
Pay. Date : 2021-07-13
DMF Number : 36108
Submission : 2021-07-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-04
Pay. Date : 2015-09-18
DMF Number : 29585
Submission : 2015-07-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-07
Pay. Date : 2020-04-15
DMF Number : 33546
Submission : 2019-12-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-04
Pay. Date : 2017-07-27
DMF Number : 30800
Submission : 2016-07-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25866
Submission : 2012-03-28
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39994
Submission : 2024-05-29
Status : Active
Type : II
Portfolio PDF
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Corporate PDF
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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