01 1Yicheng Goto Pharmaceuticals Co Ltd
01 1ANDROSTENEDIONE
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31718
Submission : 2017-04-20
Status : Active
Type : II
A Androstenedione manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Androstenedione, including repackagers and relabelers. The FDA regulates Androstenedione manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Androstenedione API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Androstenedione supplier is an individual or a company that provides Androstenedione active pharmaceutical ingredient (API) or Androstenedione finished formulations upon request. The Androstenedione suppliers may include Androstenedione API manufacturers, exporters, distributors and traders.
click here to find a list of Androstenedione suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Androstenedione DMF (Drug Master File) is a document detailing the whole manufacturing process of Androstenedione active pharmaceutical ingredient (API) in detail. Different forms of Androstenedione DMFs exist exist since differing nations have different regulations, such as Androstenedione USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Androstenedione DMF submitted to regulatory agencies in the US is known as a USDMF. Androstenedione USDMF includes data on Androstenedione's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Androstenedione USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Androstenedione suppliers with USDMF on PharmaCompass.
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