Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Minakem (formerly Delmar Chemicals)
03 1Metrochem API Private Limited
04 1Cohance Lifesciences
05 1Dr. Reddy's Laboratories
06 1Aarti Pharmalabs
07 1Medichem S.A
08 2Neuland Laboratories
09 1ALP Pharm
10 1Actavis Inc
11 1Alembic Pharmaceuticals Limited
12 1Amoli Organics
13 1Apotex Pharmachem
14 1Aurobindo Pharma Limited
15 1Biocon
16 1Changzhou Pharmaceutical Factory
17 1Glenmark Life Sciences
18 1HEC Pharm
19 1HONOUR LAB LTD
20 1Hikal
21 1Indoco Remedies Limited
22 1Jiangxi Synergy Pharmaceutical
23 1Jubilant Generics
24 1Lee Pharma
25 2MSN Laboratories
26 1Macleods Pharmaceuticals Limited
27 1Micro Labs Limited
28 3Morepen Laboratories
29 1Natco Pharma
30 1Ningbo Menovo Pharmaceutical
31 1Optimus Pharma
32 1SINTENOVO, S.A. DE C.V.
33 1SMS Pharmaceuticals
34 2ScinoPharm Taiwan, Ltd
35 1Sichuan Qingmu Pharmaceutical
36 1Sigmapharm Laboratories, LLC
37 2Srini Pharmaceuticals
38 1Sun Pharmaceutical Industries Limited
39 1Teva API
40 1Unichem Laboratories Limited
41 1Viatris
42 1Viyash Life Sciences
43 1Zhejiang Guobang Pharmaceutical
44 1Zhejiang Hisun Pharmaceutical
45 1Zhejiang Huahai Pharmaceutical
46 1Zhejiang Supor Pharmaceuticals Co., LTD
47 1Zhejiang Tianyu Pharmaceutical Co., Ltd
48 1Zydus Lifesciences
01 15,6-DIHYDRO-3-(4-MORPHOLINYL)-1-[4-(2-OXO-1-PIPERIDINYL)PHENYL]-2(1H)-PYRIDINONE (AXBN20)
02 46APIXABAN
03 1APIXABAN (PROCESS-II)
04 1APIXABAN AMORPHOUS
05 1APIXABAN AMORPHOUS (6.58%)
06 1APIXABAN FORM H3
07 1APIXABAN NON-STERILE BULK DRUG SUBSTANCE
08 1APIXABAN UREA
09 1APIXABAN [ROUTE CODE "AX"]
01 2Canada
02 11China
03 32India
04 1Ireland
05 1Israel
06 1Mexico
07 1Poland
08 1Spain
09 2Taiwan
10 2U.S.A
01 50Active
02 4Inactive
01 27Complete
02 27Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-10
Pay. Date : 2016-12-20
DMF Number : 31166
Submission : 2016-11-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-15
Pay. Date : 2016-03-28
DMF Number : 30336
Submission : 2016-03-14
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35518
Submission : 2020-12-30
Status : Active
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34988
Submission : 2020-07-02
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 : 2016-03-11
Pay. Date : 2015-09-30
DMF Number : 29707
Submission : 2015-09-22
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 : 35969
Submission : 2021-07-01
Status : Active
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-20
Pay. Date : 2016-06-30
DMF Number : 30646
Submission : 2016-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-16
Pay. Date : 2018-06-13
DMF Number : 32422
Submission : 2018-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39444
Submission : 2024-01-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-13
Pay. Date : 2015-09-23
DMF Number : 28009
Submission : 2014-02-26
Status : Active
Type : II
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