DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Aurobindo Pharma Limited
03 2Catalent Pharma Solutions
04 1Cipla
05 1Gador SA
06 1Hetero Drugs
07 2Hubei Gedian Humanwell Pharmaceutical
08 1Ind Swift Laboratories Limited
09 2MSN Laboratories
10 1PHF SA
11 1Reliance Life Sciences Private Limited
12 2Sterling Spa
13 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
01 7DUTASTERIDE
02 1DUTASTERIDE (PROCESS-II) USP
03 1DUTASTERIDE 0.5 MG SOFT GELATIN CAPSULES
04 1DUTASTERIDE ACID
05 1DUTASTERIDE FORM I
06 1DUTASTERIDE SOFT GELATIN CAPSULES .5MG
07 3DUTASTERIDE USP
08 1DUTASTERIDE USP [ROUTE CODE - "DT"]
09 1DUTASTERIDE, NON-STERILE, BULK DRUG SUBSTANCE
01 1Argentina
02 3China
03 8India
04 2Italy
05 1Switzerland
06 2U.S.A
01 9Active
02 8Inactive
01 6Complete
02 11Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-12
Pay. Date : 2012-11-30
DMF Number : 26475
Submission : 2012-10-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-07-28
DMF Number : 29577
Submission : 2015-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14643
Submission : 1999-12-22
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-04
Pay. Date : 2013-12-10
DMF Number : 27774
Submission : 2013-12-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27763
Submission : 2013-12-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-24
Pay. Date : 2021-04-02
DMF Number : 26803
Submission : 2013-01-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-06
DMF Number : 23533
Submission : 2010-02-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33063
Submission : 2018-08-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30143
Submission : 2015-12-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-07
Pay. Date : 2015-04-30
DMF Number : 20918
Submission : 2007-10-08
Status : Active
Type : II
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 DMF (Drug Master File) is a document detailing the whole manufacturing process of Dutasteride active pharmaceutical ingredient (API) in detail. Different forms of Dutasteride DMFs exist exist since differing nations have different regulations, such as Dutasteride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dutasteride DMF submitted to regulatory agencies in the US is known as a USDMF. Dutasteride USDMF includes data on Dutasteride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dutasteride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dutasteride suppliers with USDMF on PharmaCompass.
We have 13 companies offering Dutasteride
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