Aspen API. More than just an API.
01 1Aspen API
01 1ESTRADIOL 3-ACETATE
01 1Netherlands
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34738
Submission : 2020-12-15
Status : Active
Type : II
A Estradiol Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estradiol Acetate, including repackagers and relabelers. The FDA regulates Estradiol Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estradiol Acetate 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 Estradiol Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estradiol Acetate supplier is an individual or a company that provides Estradiol Acetate active pharmaceutical ingredient (API) or Estradiol Acetate finished formulations upon request. The Estradiol Acetate suppliers may include Estradiol Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Estradiol Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Estradiol Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Estradiol Acetate active pharmaceutical ingredient (API) in detail. Different forms of Estradiol Acetate DMFs exist exist since differing nations have different regulations, such as Estradiol Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estradiol Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Estradiol Acetate USDMF includes data on Estradiol Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estradiol Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Estradiol Acetate suppliers with USDMF on PharmaCompass.
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