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 1BDR Lifesciences
07 1Catalent Pharma Solutions
08 1Cdymax
09 1Cipla
10 1Glenmark Life Sciences
11 1Hansoh Pharma
12 1Hetero Drugs
13 1Laurus Labs
14 1MSN Laboratories
15 1Qingfeng Pharmaceutical Group
16 2ScinoPharm Taiwan, Ltd
17 1Shandong Anhong Pharmaceutical
18 1Shilpa Medicare
19 1Sun Pharmaceutical Industries Limited
20 1Synthon Pharmaceuticals
21 1Viatris
22 1Zhejiang Jingsheng Pharmaceutical
23 2Zydus Lifesciences
01 22ENZALUTAMIDE
02 1ENZALUTAMIDE (PROCESS II)
03 1ENZALUTAMIDE [ROUTE CODE "EI"]
04 1MDV3100, 40MG, CAPSULES (SOFTGELS)
01 5China
02 13India
03 1Ireland
04 1Netherlands
05 1Poland
06 2Taiwan
07 2U.S.A
01 22Active
02 3Inactive
01 15Complete
02 10Blank
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 : 2021-01-14
Pay. Date : 2020-12-21
DMF Number : 34886
Submission : 2020-06-24
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 : 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 : Complete
Rev. Date : 2016-05-12
Pay. Date : 2016-02-29
DMF Number : 30304
Submission : 2016-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-06-01
Pay. Date : 2020-05-12
DMF Number : 34489
Submission : 2019-12-31
Status : Active
Type : II
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