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 1Supriya Lifescience
05 1Aurobindo Pharma Limited
06 1Bakul Group
07 1CSPC New Nova Pharmaceutical
08 1CSPC Pharmaceutical Group
09 1Fleming Laboratories
10 1Guangzhou Tosun Pharmaceutical
11 1Gurvey & Berry
12 1Hikal
13 1Ipca Laboratories
14 1Labochem Ltd
15 1POLI INDUSTRIA CHIMICA SPA
16 2Perrigo API India Private Limited
17 1Plantex Ltd.
18 1RR LIFESCIENCES
19 1SPC Lifesciences Pvt. Ltd
20 1Saneca Pharmaceuticals
21 1Sinbiotik
22 1Solara Active Pharma Sciences
23 3Sun Pharmaceutical Industries Limited
24 1Suvan Lifesciences
25 1Teva API
26 1Teva Pharmaceutical Industries
27 1Zentiva
28 1Zydus Lifesciences
29 1Blank
01 1Canada
02 3China
03 1Czech Republic
04 1Greece
05 17India
06 3Israel
07 1Italy
08 1Mexico
09 1Poland
10 1Slovakia
11 1U.S.A
12 1Blank
01 5Active
02 9Inactive
03 18Blank
01 1Expired
02 8Valid
03 1Withdrawn by Holder
04 22Blank
01 32Blank
01 1WC-0094
02 1WC-0133
03 1WC-0159
04 1WC-0168
05 1WC-0216
06 1WC-0218
07 1WC-0229A3
08 1WC-0290n
09 1WC-0375
10 23Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-16
Pay. Date : 2014-11-28
DMF Number : 20976
Submission : 2007-10-26
Status : Active
Type : II
Certificate Number : R1-CEP 2004-246 - Rev 05
Issue Date : 2023-01-27
Type : Chemical
Substance Number : 851
Status : Valid
NDC Package Code : 12658-0434
Start Marketing Date : 1998-07-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2021-07-14
Registration Number : 20210714-209-J-1069
Manufacturer Name : Pharmaceutical Works Polpharma SA@[Starting Material Manufacturing Plant] Bakul Pharma Pvt. Ltd.
Manufacturer Address : 19, Pelplinska street, 83-200 Starogard Gdanski, Poland@[Starting material manufacturing plant] Plot No. 6202, GIDC Ankleshwar 393 002, Dist. Bharuch, Gujarat, India
Available Reg Filing : ASMF, CN |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Certificate Number : R0-CEP 2018-294 - Rev 00
Issue Date : 2021-01-12
Type : Chemical
Substance Number : 851
Status : Valid
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0218
Address of the Firm :
NDC Package Code : 61281-3500
Start Marketing Date : 2016-11-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : EU |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25899
Submission : 2012-03-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12562
Submission : 1997-06-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14987
Submission : 2000-07-25
Status : Active
Type : II
Certificate Number : CEP 1998-139 - Rev 06
Issue Date : 2023-10-02
Type : Chemical
Substance Number : 851
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159
Address of the Firm :
NDC Package Code : 62756-117
Start Marketing Date : 2021-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2021-09-24
Registration Number : 20210427-209-J-502(1)
Manufacturer Name : Sun Pharmaceutical Industries Ltd.@[Starting Material Manufacturing Site] Bajaj Healthcare Limited (Unit 2)
Manufacturer Address : Plot No. 24/2 & 25, Phase-IV, GIDC Industrial Zone, AT & Post Panoli-394 116, District Bharuch, Gujarat State, India@[Starting Material Manufacturing Plant] Block No. 588, Savl Karachia Road, AT & POST Gothada – 391 776, Dist: Vadodara, Gujarat State India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8324
Submission : 1989-12-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6485
Submission : 1986-07-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10374
Submission : 1993-07-21
Status : Inactive
Type : II
Certificate Number : R1-CEP 2008-012 - Rev 04
Issue Date : 2022-05-06
Type : Chemical
Substance Number : 851
Status : Valid
Date of Issue : 2020-10-15
Valid Till : 2023-10-14
Written Confirmation Number : WC-0133
Address of the Firm :
Registrant Name : Handok Co., Ltd.
Registration Date : 2021-04-16
Registration Number : 20210416-209-J-939
Manufacturer Name : Zentiva Private Limited@BAKUL PHARMA PRIVATE LIMITED@Bajaj Healthcare Limited (Unit-2)
Manufacturer Address : Plot No. 3501 to 3515, 6301 to 6313 & 16 meter road/c, GIDC Estate, Ankleshwar – 393 002, Dist. Bharuch, Gujarat State, India@Plot No. 6202, GIDC, City : Ankleshwar-393 002, Dist : Bharuch, Gujarat state, India@Block No. 588, Savli Karachia Road, At & Post - Gothada, Tal-Savli, Dist - Vadodara - 391 776, India
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