Indena - Advancing botanical science with a century of innovation, quality, and trusted global expertise.
01 1Indena
02 1Mallinckrodt Pharmaceuticals
03 1Pfizer Inc
04 1Blank
01 3RESERPINE
02 1RESERPINE USP
01 1Ireland
02 1Italy
03 1U.S.A
04 1Blank
01 1Active
02 3Inactive
01 1Complete
02 3Blank
Indena - Advancing botanical science with a century of innovation, quality, and trusted global expertise.
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-25
Pay. Date : 2014-07-07
DMF Number : 4942
Submission : 1983-04-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 192
Submission : 1956-02-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 147
Submission : 1954-09-02
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 193
Submission : 1956-02-17
Status : Inactive
Type : II
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PharmaCompass offers a list of Reserpine 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 Reserpine manufacturer or Reserpine supplier for your needs.
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PharmaCompass also assists you with knowing the Reserpine API Price utilized in the formulation of products. Reserpine API Price is not always fixed or binding as the Reserpine Price is obtained through a variety of data sources. The Reserpine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Unipres manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Unipres, including repackagers and relabelers. The FDA regulates Unipres manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Unipres API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Unipres supplier is an individual or a company that provides Unipres active pharmaceutical ingredient (API) or Unipres finished formulations upon request. The Unipres suppliers may include Unipres API manufacturers, exporters, distributors and traders.
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A Unipres DMF (Drug Master File) is a document detailing the whole manufacturing process of Unipres active pharmaceutical ingredient (API) in detail. Different forms of Unipres DMFs exist exist since differing nations have different regulations, such as Unipres USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Unipres DMF submitted to regulatory agencies in the US is known as a USDMF. Unipres USDMF includes data on Unipres's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Unipres USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Unipres suppliers with USDMF on PharmaCompass.
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