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
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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
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DMF Number : 16983
Submission : 2003-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 16713
Submission : 2003-07-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 15882
Submission : 2002-02-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 17594
Submission : 2004-08-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 17656
Submission : 2004-09-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
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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 :
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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
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