01 1Yabao Pharmaceutical Group Co. Ltd
01 1PROMESTRIENE
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28361
Submission : 2014-06-06
Status : Active
Type : II
A Promestriene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Promestriene, including repackagers and relabelers. The FDA regulates Promestriene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Promestriene 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 Promestriene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Promestriene supplier is an individual or a company that provides Promestriene active pharmaceutical ingredient (API) or Promestriene finished formulations upon request. The Promestriene suppliers may include Promestriene API manufacturers, exporters, distributors and traders.
click here to find a list of Promestriene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Promestriene DMF (Drug Master File) is a document detailing the whole manufacturing process of Promestriene active pharmaceutical ingredient (API) in detail. Different forms of Promestriene DMFs exist exist since differing nations have different regulations, such as Promestriene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Promestriene DMF submitted to regulatory agencies in the US is known as a USDMF. Promestriene USDMF includes data on Promestriene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Promestriene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Promestriene suppliers with USDMF on PharmaCompass.
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