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01 1AMF QAE-CELLULOSE-1 ION EXCHG.MEDIA(STAFFORD SPRINGS & TALCOTTVILLE,CT
02 1TALC
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01 1Active
02 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36716
Submission : 2022-01-20
Status : Active
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5393
Submission : 1984-05-31
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Talc API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Talc API, including repackagers and relabelers. The FDA regulates Talc API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Talc API 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 Talc API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Talc API supplier is an individual or a company that provides Talc API active pharmaceutical ingredient (API) or Talc API finished formulations upon request. The Talc API suppliers may include Talc API API manufacturers, exporters, distributors and traders.
click here to find a list of Talc API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Talc API DMF (Drug Master File) is a document detailing the whole manufacturing process of Talc API active pharmaceutical ingredient (API) in detail. Different forms of Talc API DMFs exist exist since differing nations have different regulations, such as Talc API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Talc API DMF submitted to regulatory agencies in the US is known as a USDMF. Talc API USDMF includes data on Talc API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Talc API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Talc API suppliers with USDMF on PharmaCompass.
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