Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 2Dr. Reddy's Laboratories
03 1Neuland Laboratories
04 2Alembic Pharmaceuticals Limited
05 1Alkem Laboratories
06 1Aurobindo Pharma Limited
07 1Changzhou Pharmaceutical Factory
08 1Cipla
09 1Glenmark Life Sciences
10 1HEC Pharm
11 1Hainan Poly Pharm
12 1Hetero Drugs
13 1Intas Pharmaceuticals
14 1Jubilant Generics
15 1Lek Pharmaceuticals
16 2Lupin Ltd
17 4MSN Laboratories
18 1Macleods Pharmaceuticals Limited
19 2Quimica Sintetica
20 1Raks Pharma
21 1ScinoPharm Taiwan, Ltd
22 1Sun Pharmaceutical Industries Limited
23 1Unichem Laboratories Limited
24 1Viatris
25 1Zhejiang Huahai Pharmaceutical
26 1Zhejiang Huayi Pharmaceutical Co., Ltd.
27 1Zydus Lifesciences
01 22APREMILAST
02 2APREMILAST (AMORPHOUS)
03 1APREMILAST (CRYSTALLINE)
04 1APREMILAST (FORM B)
05 1APREMILAST (FORM M)
06 2APREMILAST (FORM-B)
07 1APREMILAST (FORM-M)
08 1APREMILAST (PROCESS II)
09 1APREMILAST NON-STERILE BULK DRUG SUBSTANCE
10 1APREMILAST [AMORPHOUS]
11 1APREMILAST [ROUTE CODE LI]
01 5China
02 23India
03 1Poland
04 1Slovenia
05 2Spain
06 1Taiwan
07 1U.S.A
01 33Active
02 1Inactive
01 25Complete
02 9Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-07
Pay. Date : 2016-12-20
DMF Number : 31141
Submission : 2016-11-09
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 : 2017-01-05
Pay. Date : 2016-11-15
DMF Number : 30732
Submission : 2016-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32953
Submission : 2018-11-06
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 : 2017-10-02
Pay. Date : 2017-08-29
DMF Number : 31356
Submission : 2017-06-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-09
Pay. Date : 2017-05-25
DMF Number : 31266
Submission : 2017-03-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-24
Pay. Date : 2016-04-04
DMF Number : 30248
Submission : 2016-04-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-03
Pay. Date : 2016-09-29
DMF Number : 30332
Submission : 2016-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-20
Pay. Date : 2017-10-10
DMF Number : 31159
Submission : 2016-12-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-17
Pay. Date : 2017-10-10
DMF Number : 30866
Submission : 2016-08-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-01
Pay. Date : 2016-12-27
DMF Number : 31180
Submission : 2016-12-29
Status : Active
Type : II
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