01 1Beckman Coulter
02 1Laboratorio Syntex S.A
03 1National Institutes of Health
04 1Qingdao Kangyuan Pharma
05 1Salk Institute
06 1Blank
01 2CHORIONIC GONADOTROPIN
02 1COMPOUND [IMBZL)-D-HIS 6, PRO 9-NET}-GNRH
03 1GONADORELIN BULK DRY SUBSTANCE
04 1GONADOTROPIN RELEASING HORMONE (GNRH)
05 1SYNTHETIC LUTEINIZING HORMONE-RELEASING HORMONE (PORCINE, OVIVE)
01 1Argentina
02 1China
03 3U.S.A
04 1Blank
01 1Active
02 5Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2126
Submission : 1973-07-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3368
Submission : 1978-09-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9520
Submission : 1992-01-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31909
Submission : 2017-07-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4345
Submission : 1981-10-27
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4410
Submission : 1982-01-07
Status : Inactive
Type : II
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A Gonadorelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gonadorelin, including repackagers and relabelers. The FDA regulates Gonadorelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gonadorelin 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 Gonadorelin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gonadorelin supplier is an individual or a company that provides Gonadorelin active pharmaceutical ingredient (API) or Gonadorelin finished formulations upon request. The Gonadorelin suppliers may include Gonadorelin API manufacturers, exporters, distributors and traders.
click here to find a list of Gonadorelin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gonadorelin DMF (Drug Master File) is a document detailing the whole manufacturing process of Gonadorelin active pharmaceutical ingredient (API) in detail. Different forms of Gonadorelin DMFs exist exist since differing nations have different regulations, such as Gonadorelin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gonadorelin DMF submitted to regulatory agencies in the US is known as a USDMF. Gonadorelin USDMF includes data on Gonadorelin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gonadorelin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gonadorelin suppliers with USDMF on PharmaCompass.
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