Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 2Polpharma
02 1LGM Pharma
03 1Dr. Reddy's Laboratories
04 1Jai Radhe Sales
05 1Laboratorium Ofichem B.V
06 1HRV Global Life Sciences
07 1TAPI Technology & API Services
08 1Apotex Pharmachem
09 1Aurobindo Pharma Limited
10 1CHEMO
11 1Chemi SpA
12 1Chongqing Shenghuaxi Pharma. Co., Ltd
13 2Chromo Laboratories
14 1Deva Holding AS
15 1Emcure Pharmaceuticals
16 1Fleming Laboratories
17 1Gador SA
18 1JPN Pharma
19 1Lee Pharma
20 1Macleods Pharmaceuticals Limited
21 1Mustafa Nevzat Ilac Sanayi A S
22 2Natco Pharma
23 1Orchid Pharma
24 1RR LIFESCIENCES
25 1Roche Diagnostics GmbH
26 1Saurav Chemicals
27 1Sun Pharmaceutical Industries Limited
28 1Teva Pharmaceutical Industries
29 1Trifarma
30 1Unipex
31 1Vaishali Pharma Ltd
32 1Viatris
01 1Argentina
02 1Canada
03 1China
04 1France
05 1Germany
06 18India
07 2Israel
08 2Italy
09 1Netherlands
10 2Poland
11 1Spain
12 2Turkey
13 2U.S.A
01 11Active
02 3Inactive
03 21Blank
01 3Valid
02 32Blank
01 1303MF10116
02 34Blank
01 1WC-0014
02 1WC-0067
03 1WC-0159
04 1WC-0226
05 1WC-0317
06 1WC-0317A2
07 1WC-0336
08 28Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-12
Pay. Date : 2016-06-21
DMF Number : 25638
Submission : 2011-12-29
Status : Active
Type : II
Certificate Number : R0-CEP 2023-077 - Rev 00
Issue Date : 2023-06-30
Type : Chemical
Substance Number : 2771
Status : Valid
Registration Number : 303MF10116
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2021-07-20
Latest Date of Registration : --
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2019-08-02
Registration Number : No. 2417-3-ND(1)
Manufacturer Name : Pharmaceutical Works Polpharma S.A.
Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 55111-872
Start Marketing Date : 2007-04-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
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 : 20494
Submission : 2007-04-30
Status : Inactive
Type : II
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Certificate Number : R0-CEP 2022-073 - Rev 00
Issue Date : 2023-02-20
Type : Chemical
Substance Number : 2771
Status : Valid
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2019-08-02
Registration Number : No. 2417-3-ND(1)
Manufacturer Name : Pharmaceutical Works Polpharma S.A.
Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20525
Submission : 2007-05-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20411
Submission : 2007-04-05
Status : Active
Type : II
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0014
Address of the Firm :
NDC Package Code : 63850-4355
Start Marketing Date : 2016-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2013-03-06
Registration Number : No. 5616-1-ND(1)
Manufacturer Name : NATCO PHARMA LIMITED
Manufacturer Address : Mekaguda Village, Kothur (Mandal) Mahaboobnagar district Telangana, India(Pin: 509 223)_x000D_
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-10
Pay. Date : 2013-07-23
DMF Number : 24824
Submission : 2011-05-31
Status : Active
Type : II
NDC Package Code : 63850-4355
Start Marketing Date : 2016-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2013-03-06
Registration Number : No. 5616-1-ND(1)
Manufacturer Name : NATCO PHARMA LIMITED
Manufacturer Address : Mekaguda Village, Kothur (Mandal) Mahaboobnagar district Telangana, India(Pin: 509 223)_x000D_
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20427
Submission : 2007-04-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20422
Submission : 2007-04-09
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-10
Pay. Date : 2013-09-23
DMF Number : 25793
Submission : 2012-04-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25172
Submission : 2011-09-09
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
NDC Package Code : 14593-853
Start Marketing Date : 2022-02-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20391
Submission : 2007-03-31
Status : Active
Type : II
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2015-01-12
Registration Number : Su730-1-ND
Manufacturer Name : Chongqing Shenghuaxi Pharmaceutical Co., Ltd.
Manufacturer Address : No.8, Jiangqiao Road, Nan'an District Chongqing, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20605
Submission : 2007-06-06
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-10
Pay. Date : 2013-01-04
DMF Number : 20393
Submission : 2007-03-29
Status : Active
Type : II
NDC Package Code : 65862-270
Start Marketing Date : 2024-01-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15429
Submission : 2001-05-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23350
Submission : 2009-12-08
Status : Inactive
Type : II
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2016-08-24
Registration Number : No. 4554-1-ND(7)
Manufacturer Name : Gador. SA
Manufacturer Address : Calle 10, Fraccion Ⅲ, Parcela 7, Parque Industrial Pilar B1630CFA of the Province of Buenos Aires, Argentine Republic
Certificate Number : CEP 2022-338 - Rev 00
Issue Date : 2024-06-21
Type : Chemical
Substance Number : 2771
Status : Valid
Registrant Name : Hiple Co., Ltd.
Registration Date : 2020-09-08
Registration Number : No. 4766-1-ND(5)
Manufacturer Name : Fleming Laboratories Limited
Manufacturer Address : Plot No. 152&160, Phase-V, IDA, Jeedimetla(V), Quthbullapur(M) Medchal-Malkajgiri District Telangana State, India
Date of Issue : 2022-03-04
Valid Till : 2024-12-16
Written Confirmation Number : WC-0336
Address of the Firm :
Date of Issue : 2020-11-27
Valid Till : 2021-06-07
Written Confirmation Number : WC-0317A2
Address of the Firm :
Date of Issue : 2022-02-02
Valid Till : 2024-06-07
Written Confirmation Number : WC-0317
Address of the Firm :
A Ibandronate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibandronate Sodium, including repackagers and relabelers. The FDA regulates Ibandronate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibandronate Sodium 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 Ibandronate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ibandronate Sodium supplier is an individual or a company that provides Ibandronate Sodium active pharmaceutical ingredient (API) or Ibandronate Sodium finished formulations upon request. The Ibandronate Sodium suppliers may include Ibandronate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Ibandronate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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