01 1APITORIA PHARMA PRIVATE LIMITED Hyderabad IN
02 1CIPLA LIMITED Mumbai IN
03 1HETERO LABS LIMITED Hyderabad IN
04 1Hubei Gedian Humanwell Pharmaceutical Co., Ltd. Ezhou City CN
05 1MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN
06 1STERLING CHEMICAL MALTA LTD. Birzebbugia MT
01 3Dutasteride
02 1Dutasteride, Form I
03 1Dutasteride, Non-micronised and micronised
04 1Dutasteride, Route "DJ"
01 1China
02 4India
03 1Italy
01 4Valid
02 2Withdrawn by Holder
Certificate Number : CEP 2014-306 - Rev 01
Status : Valid
Issue Date : 2023-11-16
Type : Chemical
Substance Number : 2641
Certificate Number : R0-CEP 2015-050 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2017-06-15
Type : Chemical
Substance Number : 2641
Certificate Number : R1-CEP 2016-126 - Rev 00
Status : Valid
Issue Date : 2022-07-26
Type : Chemical
Substance Number : 2641
Dutasteride, Non-micronised And Micronised
Certificate Number : CEP 2020-298 - Rev 02
Status : Valid
Issue Date : 2024-12-13
Type : Chemical
Substance Number : 2641
Certificate Number : R1-CEP 2015-252 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2021-01-15
Type : Chemical
Substance Number : 2641
Certificate Number : CEP 2015-258 - Rev 01
Status : Valid
Issue Date : 2024-02-06
Type : Chemical
Substance Number : 2641
A Dutasteride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dutasteride, including repackagers and relabelers. The FDA regulates Dutasteride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dutasteride 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 Dutasteride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dutasteride supplier is an individual or a company that provides Dutasteride active pharmaceutical ingredient (API) or Dutasteride finished formulations upon request. The Dutasteride suppliers may include Dutasteride API manufacturers, exporters, distributors and traders.
click here to find a list of Dutasteride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dutasteride CEP of the European Pharmacopoeia monograph is often referred to as a Dutasteride Certificate of Suitability (COS). The purpose of a Dutasteride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dutasteride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dutasteride to their clients by showing that a Dutasteride CEP has been issued for it. The manufacturer submits a Dutasteride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dutasteride CEP holder for the record. Additionally, the data presented in the Dutasteride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dutasteride DMF.
A Dutasteride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dutasteride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Dutasteride suppliers with CEP (COS) on PharmaCompass.
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