01 2ENDORECHERCHE INC
01 1ACOLBIFENE CAPSULES, 20 MG
02 1ACOLBIFENE, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT
01 2Canada
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19269
Submission : 2006-03-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19515
Submission : 2006-06-09
Status : Inactive
Type : II
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PharmaCompass offers a list of Acolbifene API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Acolbifene manufacturer or Acolbifene supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Acolbifene manufacturer or Acolbifene supplier.
PharmaCompass also assists you with knowing the Acolbifene API Price utilized in the formulation of products. Acolbifene API Price is not always fixed or binding as the Acolbifene Price is obtained through a variety of data sources. The Acolbifene Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Acolbifene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acolbifene, including repackagers and relabelers. The FDA regulates Acolbifene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acolbifene 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 Acolbifene supplier is an individual or a company that provides Acolbifene active pharmaceutical ingredient (API) or Acolbifene finished formulations upon request. The Acolbifene suppliers may include Acolbifene API manufacturers, exporters, distributors and traders.
click here to find a list of Acolbifene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acolbifene DMF (Drug Master File) is a document detailing the whole manufacturing process of Acolbifene active pharmaceutical ingredient (API) in detail. Different forms of Acolbifene DMFs exist exist since differing nations have different regulations, such as Acolbifene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acolbifene DMF submitted to regulatory agencies in the US is known as a USDMF. Acolbifene USDMF includes data on Acolbifene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acolbifene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acolbifene suppliers with USDMF on PharmaCompass.
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