Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1LGM Pharma
03 1Jai Radhe Sales
04 1Century Pharmaceuticals
05 1Shandong Loncom Pharmaceutical
06 1AASraw Biochemical Technology Co., Ltd
07 1Alembic Pharmaceuticals Limited
08 2Chromo Laboratories
09 1Guangzhou Tosun Pharmaceutical
10 1Hangzhou Longshine Bio-Tech
11 1Hangzhou Think Chemical Co.Ltd
12 2Macleods Pharmaceuticals Limited
13 1Phalanx Labs
14 1Raks Pharma
15 1Rakshit Drugs
16 1Remedy Labs
17 2SMS Pharmaceuticals
18 1Synaptics Labs
19 1Tianish Laboratories
20 1Ultratech India Ltd.,
21 1Unipex
22 1Viatris
23 1Xian Tian Guangyuan Biotech
01 6China
02 1France
03 16India
04 1Poland
05 2U.S.A
01 6Active
02 20Blank
01 5Valid
02 21Blank
01 1231MF10080
02 1301MF10002
03 24Blank
01 1WC-0079A1
02 1WC-0079a
03 1WC-0082
04 1WC-0317
05 1WC-0317A2
06 1WC-0373
07 1WC-0373A4
08 1WC-257
09 18Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-15
Pay. Date : 2015-08-21
DMF Number : 25174
Submission : 2011-08-02
Status : Active
Type : II
Certificate Number : CEP 2014-106 - Rev 02
Issue Date : 2024-05-29
Type : Chemical
Substance Number : 2782
Status : Valid
Registration Number : 231MF10080
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2019-04-03
Latest Date of Registration : --
NDC Package Code : 12658-0463
Start Marketing Date : 2003-08-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2018-10-28
Registration Number : 20181028-211-J-269
Manufacturer Name : Pharmaceutical Works Polpharma S.A.
Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland
Available Reg Filing : ASMF, CA, CN |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-20
Pay. Date : 2014-12-24
DMF Number : 28900
Submission : 2014-12-31
Status : Active
Type : II
Certificate Number : R1-CEP 2015-095 - Rev 01
Issue Date : 2023-06-26
Type : Chemical
Substance Number : 2782
Status : Valid
Registration Number : 301MF10002
Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India
Initial Date of Registration : 2019-05-08
Latest Date of Registration : --
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2018-02-22
Registration Number : 20180222-211-J-181
Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-III)
Manufacturer Address : Plot No. 842-843, Taluka-Padra, City : Karakhadi - 391 450, District-Vadodara Gujarat State, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-05
Pay. Date : 2016-10-03
DMF Number : 30804
Submission : 2016-10-27
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-13
Pay. Date : 2013-07-10
DMF Number : 25795
Submission : 2012-04-09
Status : Active
Type : II
Certificate Number : R1-CEP 2015-207 - Rev 00
Issue Date : 2021-09-21
Type : Chemical
Substance Number : 2782
Status : Valid
Date of Issue : 2020-07-22
Valid Till : 2022-07-02
Written Confirmation Number : WC-0079A1
Address of the Firm :
NDC Package Code : 33342-504
Start Marketing Date : 2016-02-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33220
Submission : 2019-03-07
Status : Active
Type : II
Date of Issue : 2022-02-02
Valid Till : 2024-06-07
Written Confirmation Number : WC-0317
Address of the Firm :
NDC Package Code : 52562-004
Start Marketing Date : 2020-12-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32908
Submission : 2018-09-20
Status : Active
Type : II
Certificate Number : CEP 2018-202 - Rev 01
Issue Date : 2024-04-04
Type : Chemical
Substance Number : 2782
Status : Valid
Date of Issue : 2022-07-08
Valid Till : 2025-07-21
Written Confirmation Number : WC-0373
Address of the Firm :
NDC Package Code : 67835-0014
Start Marketing Date : 2018-03-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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