Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Aarti Pharmalabs
03 1Dr. Reddy's Laboratories
04 1Actavis Inc
05 1Aurisco Pharmaceutical
06 1Catalent Pharma Solutions
07 1Cdymax
08 1Cipla
09 1Glenmark Life Sciences
10 1Hetero Drugs
11 1Laurus Labs
12 1MSN Laboratories
13 1Qingfeng Pharmaceutical Group
14 1Sai Life Sciences Limited
15 2ScinoPharm Taiwan, Ltd
16 1Shandong Anhong Pharmaceutical
17 1Shilpa Medicare
18 1Sun Pharmaceutical Industries Limited
19 1Synthon Pharmaceuticals
20 1Viatris
21 1Zhejiang Jingsheng Pharmaceutical
22 2Zydus Lifesciences
01 14-((2-CYANOPROPAN-2-YL)AMINO)-2-FLUORO-N-METHYLBENZAMIDE (ENZALUTAMIDE INTERMEDIATE)
02 20ENZALUTAMIDE
03 1ENZALUTAMIDE (PROCESS II)
04 1ENZALUTAMIDE [ROUTE CODE "EI"]
05 1MDV3100, 40MG, CAPSULES (SOFTGELS)
01 4China
02 13India
03 1Ireland
04 1Netherlands
05 1Poland
06 2Taiwan
07 2U.S.A
01 22Active
02 2Inactive
01 13Complete
02 11Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39560
Submission : 2024-04-04
Status : Active
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35618
Submission : 2021-04-28
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-11
Pay. Date : 2014-12-30
DMF Number : 29117
Submission : 2015-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-06
Pay. Date : 2016-05-13
DMF Number : 29872
Submission : 2016-05-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-24
Pay. Date : 2016-12-20
DMF Number : 31196
Submission : 2016-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-06-01
Pay. Date : 2020-05-05
DMF Number : 30279
Submission : 2016-02-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29062
Submission : 2015-03-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-13
Pay. Date : 2016-03-08
DMF Number : 30260
Submission : 2016-03-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30010
Submission : 2015-11-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-12
Pay. Date : 2016-02-29
DMF Number : 30304
Submission : 2016-03-29
Status : Active
Type : II
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