EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
02 1Dr. Reddy's Laboratories
03 1USV Private Limited
04 1Chongqing Carelife Pharmaceutical
05 1Dishman Carbogen Amcis
06 1Glenmark Life Sciences
07 1Hetero Drugs
08 1Hubei Haosun Pharmaceutical Co., Ltd.
09 1Indoco Remedies Limited
10 1Ipca Laboratories
11 1MSN Laboratories
12 1Micro Labs Limited
13 1Shandong Xinhua Pharmaceutical
14 2Sun Pharmaceutical Industries Limited
15 1Urquima S.A. Grupo Uriach
16 1Yangtze River Pharmaceutical Group
01 5GLIMEPIRIDE
02 1GLIMEPIRIDE (PROCESS 2)
03 1GLIMEPIRIDE NON-STERILE BULK DRUG SUBSTANCE
04 9GLIMEPIRIDE USP
05 1GLIMEPIRIDE, MICRONISED
01 4China
02 1France
03 11India
04 1Spain
01 12Active
02 5Inactive
01 2Complete
02 15Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37318
Submission : 2022-07-18
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16983
Submission : 2003-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16713
Submission : 2003-07-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15882
Submission : 2002-02-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17594
Submission : 2004-08-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17656
Submission : 2004-09-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22565
Submission : 2009-01-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-20
Pay. Date : 2013-11-06
DMF Number : 20037
Submission : 2006-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32319
Submission : 2017-11-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32617
Submission : 2018-04-23
Status : Active
Type : II
A Glimepiride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glimepiride, including repackagers and relabelers. The FDA regulates Glimepiride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glimepiride 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 Glimepiride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glimepiride supplier is an individual or a company that provides Glimepiride active pharmaceutical ingredient (API) or Glimepiride finished formulations upon request. The Glimepiride suppliers may include Glimepiride API manufacturers, exporters, distributors and traders.
click here to find a list of Glimepiride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glimepiride DMF (Drug Master File) is a document detailing the whole manufacturing process of Glimepiride active pharmaceutical ingredient (API) in detail. Different forms of Glimepiride DMFs exist exist since differing nations have different regulations, such as Glimepiride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glimepiride DMF submitted to regulatory agencies in the US is known as a USDMF. Glimepiride USDMF includes data on Glimepiride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glimepiride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glimepiride suppliers with USDMF on PharmaCompass.
We have 16 companies offering Glimepiride
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