01 2Apicore LLC
02 1Auro Peptides Limited
03 1Fresenius Kabi Anti-Infectives
04 1Hansoh Pharma
05 1Hybio Pharmaceutical
06 1Lianyungang Runzhong Pharmaceutical Co Ltd
07 1Shenzhen JYMed Technology
01 1DEGARELIX
02 2DEGARELIX ACETATE
03 1DEGARELIX ACETATE MANNITOL PREMIX 29% (STERILE)
04 1DEGARELIX ACETATE MANNITOL PREMIX 45% (STERILE)
05 1DEGARELIX ACETATE NON-STERILE BULK DRUG SUBSTANCE
06 1DEGARELIX ACETATE, NON-STERILE DRUG SUBSTANCE
07 1DEGARELIX ACETATE, NON-STERILE, BULK DRUG SUBSTANCE
01 4China
02 3India
03 1Italy
01 8Active
01 5Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37113
Submission : 2023-04-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37005
Submission : 2023-04-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-08
Pay. Date : 2020-08-07
DMF Number : 35078
Submission : 2020-08-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-27
Pay. Date : 2022-12-05
DMF Number : 36499
Submission : 2023-01-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-24
Pay. Date : 2021-09-17
DMF Number : 36216
Submission : 2022-01-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38904
Submission : 2023-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-08
Pay. Date : 2020-10-19
DMF Number : 35257
Submission : 2020-10-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-09
Pay. Date : 2019-03-01
DMF Number : 33550
Submission : 2019-02-21
Status : Active
Type : II
A Degarelix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Degarelix, including repackagers and relabelers. The FDA regulates Degarelix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Degarelix 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 Degarelix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Degarelix supplier is an individual or a company that provides Degarelix active pharmaceutical ingredient (API) or Degarelix finished formulations upon request. The Degarelix suppliers may include Degarelix API manufacturers, exporters, distributors and traders.
click here to find a list of Degarelix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Degarelix DMF (Drug Master File) is a document detailing the whole manufacturing process of Degarelix active pharmaceutical ingredient (API) in detail. Different forms of Degarelix DMFs exist exist since differing nations have different regulations, such as Degarelix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Degarelix DMF submitted to regulatory agencies in the US is known as a USDMF. Degarelix USDMF includes data on Degarelix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Degarelix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Degarelix suppliers with USDMF on PharmaCompass.
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