01 1Cipla
02 1Fujifilm Diosynth Biotechnologies
03 1Organon
04 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
01 116A-BROMOEPIANDROSTERONE
02 13BETA,5-DIHYDROXY-6BETA, 7BETA:15BETA, 16BETA-DIMETHYLENE-5BETA-ANDROSTAN-17-ONE (Q5)
03 2ANDROSTERONE
01 1China
02 1India
03 1U.S.A
04 1United Kingdom
01 1Active
02 3Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13887
Submission : 1998-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5283
Submission : 1983-11-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1766
Submission : 1971-07-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29813
Submission : 2015-09-01
Status : Active
Type : II
A Androsterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Androsterone, including repackagers and relabelers. The FDA regulates Androsterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Androsterone 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 Androsterone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Androsterone supplier is an individual or a company that provides Androsterone active pharmaceutical ingredient (API) or Androsterone finished formulations upon request. The Androsterone suppliers may include Androsterone API manufacturers, exporters, distributors and traders.
click here to find a list of Androsterone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Androsterone DMF (Drug Master File) is a document detailing the whole manufacturing process of Androsterone active pharmaceutical ingredient (API) in detail. Different forms of Androsterone DMFs exist exist since differing nations have different regulations, such as Androsterone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Androsterone DMF submitted to regulatory agencies in the US is known as a USDMF. Androsterone USDMF includes data on Androsterone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Androsterone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Androsterone suppliers with USDMF on PharmaCompass.
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