Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Cohance Lifesciences
03 1Dr. Reddy's Laboratories
04 1Taro Pharmaceutical Industries
05 1Neuland Laboratories
06 1USV Private Limited
07 1Alembic Pharmaceuticals Limited
08 1CTX Lifesciences
09 3Changzhou Pharmaceutical Factory
10 1Divis Laboratories
11 1HEC Pharm
12 1HONOUR LAB LTD
13 1Innovare Labs
14 1Jiangxi Synergy Pharmaceutical
15 1Jubilant Generics
16 4Kaiyuan Hengtai Pharma Co., Ltd.
17 1Lek Pharmaceuticals
18 2MSN Laboratories
19 1Macleods Pharmaceuticals Limited
20 1Mankind Pharma
21 1Micro Labs Limited
22 1PharmaResources
23 1Raks Pharma
24 1Shanghai Huilun Pharmaceutical
25 1Sichuan Qingmu Pharmaceutical
26 1Teva API
27 1Unichem Laboratories Limited
28 1Viatris
29 1Viyash Life Sciences
30 1WUHAN ZY PHARMACEUTICAL CO LTD
31 1Zhejiang Hisun Pharmaceutical
32 1Zhejiang Jingxin Pharmaceutical Co. ltd
33 1Zhejiang Supor Pharmaceuticals Co., LTD
34 1Zhejiang Tianyu Pharmaceutical Co., Ltd
35 1Blank
01 32TICAGRELOR
02 1TICAGRELOR (CAS: 274693-27-5)
03 1TICAGRELOR (FORM-II) [ROUTE CODE "TG2"]
04 1TICAGRELOR (ROUTE CODE: TG)
05 1TICAGRELOR FORM-II
06 1TICAGRELOR INTERMEDIATE (CODE TGA-B-4)
07 1TICAGRELOR INTERMEDIATE, (1R, 2S) -2- (3,4-DIFLUOROPHENYL) CYCLOPROPANAMINE (R)-2-HYDROXY-2-PHENYLACETATE (1:1) (CAS: 376608-71-8)
08 1TICAGRELOR INTERMEDIATE, 2-((3AR, 4S, 6R, 6AS)-6-AMINO-2, 2-DIMETHYLTETRAHYDRO-3AH-CYCLOPENTA [D] [1,3] DIOXOL-4-YLOXY) ETHANOL L-TARTARIC ACID (1:1) (CAS:376608-65-0)
09 1TICAGRELOR INTERMEDIATE, 4, 6-DICHLORO-2-(PROPYLTHIO) PYRIMIDINE-5-AMINE (CAS: 145783-15-9)
10 1TICAGRELOR NON-STERILE BULK DRUG SUBSTANCE
01 17China
02 18India
03 1Israel
04 1Poland
05 1Slovenia
06 2U.S.A
07 1Blank
01 40Active
02 1Inactive
01 21Complete
02 20Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-23
Pay. Date : 2014-11-21
DMF Number : 28674
Submission : 2014-09-24
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 : 34420
Submission : 2019-12-31
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 : 2014-10-27
Pay. Date : 2014-08-07
DMF Number : 28446
Submission : 2014-08-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33748
Submission : 2019-04-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-09
Pay. Date : 2021-03-24
DMF Number : 35767
Submission : 2021-09-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-03
Pay. Date : 2018-03-27
DMF Number : 31482
Submission : 2018-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-26
Pay. Date : 2014-12-04
DMF Number : 28787
Submission : 2015-01-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28111
Submission : 2014-02-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28112
Submission : 2014-02-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28110
Submission : 2014-02-20
Status : Active
Type : II
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