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 1TAPI Technology & API Services
06 1Aurobindo Pharma Limited
07 1Bakul Group
08 1CSPC New Nova Pharmaceutical
09 1CSPC Pharmaceutical Group
10 1Fleming Laboratories
11 1Guangzhou Tosun Pharmaceutical
12 1Gurvey & Berry
13 1Hikal
14 1Ipca Laboratories
15 1Labochem Ltd
16 1POLI INDUSTRIA CHIMICA SPA
17 2Perrigo API India Private Limited
18 1Plantex Ltd.
19 1RR LIFESCIENCES
20 1SPC Lifesciences Pvt. Ltd
21 1Saneca Pharmaceuticals
22 1Sinbiotik
23 1Solara Active Pharma Sciences
24 3Sun Pharmaceutical Industries Limited
25 1Suvan Lifesciences
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-0133
02 1WC-0159
03 1WC-0168
04 1WC-0216
05 1WC-0218
06 1WC-0229
07 1WC-0375
08 25Blank
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 : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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 : 25899
Submission : 2012-03-02
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 : 11549
Submission : 1995-06-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18249
Submission : 2005-03-29
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7639
Submission : 1988-08-17
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8858
Submission : 1990-11-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18084
Submission : 2005-02-15
Status : Inactive
Type : II
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17345
Submission : 2004-04-22
Status : Inactive
Type : II
Certificate Number : R0-CEP 2004-185 - Rev 02
Issue Date : 2006-02-17
Type : Chemical
Substance Number : 851
Status : Expired
Date of Issue : 2022-07-06
Valid Till : 2025-07-04
Written Confirmation Number : WC-0216
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
Certificate Number : CEP 2019-273 - Rev 01
Issue Date : 2024-02-15
Type : Chemical
Substance Number : 851
Status : Valid
Certificate Number : R1-CEP 2000-127 - Rev 06
Issue Date : 2020-06-04
Type : Chemical
Substance Number : 851
Status : Valid
NDC Package Code : 72643-032
Start Marketing Date : 2023-02-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2014-356 - Rev 00
Issue Date : 2021-10-07
Type : Chemical
Substance Number : 851
Status : Valid
Date of Issue : 2023-02-02
Valid Till : 2025-09-13
Written Confirmation Number : WC-0375
Address of the Firm :
Registrant Name : Klasia Co., Ltd.
Registration Date : 2020-10-08
Registration Number : 20201008-210-J-412
Manufacturer Name : BAKUL PHARMA PRIVATE LIMITED
Manufacturer Address : Plot No. 6202, GIDC, City : Ankleshwar-393 002, Dist. Bharuch, Gujarat state, India
Certificate Number : R0-CEP 2016-159 - Rev 00
Issue Date : 2017-01-09
Type : Chemical
Substance Number : 851
Status : Withdrawn by Holder
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
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
Date of Issue : 2022-08-16
Valid Till : 2025-08-13
Written Confirmation Number : WC-0229
Address of the Firm :
A Pentoxifylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentoxifylline, including repackagers and relabelers. The FDA regulates Pentoxifylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentoxifylline API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Pentoxifylline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pentoxifylline supplier is an individual or a company that provides Pentoxifylline active pharmaceutical ingredient (API) or Pentoxifylline finished formulations upon request. The Pentoxifylline suppliers may include Pentoxifylline API manufacturers, exporters, distributors and traders.
click here to find a list of Pentoxifylline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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