Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
01 1Laboratorium Ofichem B.V
02 1ChemWerth Inc
03 1Jai Radhe Sales
04 1Polfa Tarchomin
05 1TAPI Technology & API Services
06 1Apotex Pharmachem
07 2Bioindustria L.I.M. Spa
08 2Cipla
09 1Fresenius Kabi AB Brunna
10 1Fuan Pharmaceutical
11 1Gador SA
12 1Hospira, Inc.
13 1JPN Pharma
14 1SNA Healthcare
15 1Sun Pharmaceutical Industries Limited
16 1Teva Pharmaceutical Industries
17 1Trifarma
18 1Vaishali Pharma Ltd
01 1Argentina
02 1Canada
03 1China
04 7India
05 2Israel
06 3Italy
07 1Netherlands
08 1Poland
09 1Sweden
10 2U.S.A
01 2Active
02 7Inactive
03 11Blank
01 1Valid
02 1Withdrawn by Holder
03 18Blank
01 1228MF10223
02 19Blank
01 1WC-0159
02 19Blank
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
Certificate Number : CEP 2017-203 - Rev 01
Issue Date : 2023-11-17
Type : Chemical
Substance Number : 1779
Status : Valid
Registration Number : 228MF10223
Registrant's Address : Heembadweg 5, 9561 CZ Ter apel, The Netherlands
Initial Date of Registration : 2016-11-25
Latest Date of Registration : --
NDC Package Code : 62675-0718
Start Marketing Date : 2018-07-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : BR, ASMF |
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-24
Pay. Date : 2012-11-19
DMF Number : 12803
Submission : 1997-12-22
Status : Active
Type : II
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
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 : 13946
Submission : 1999-01-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14504
Submission : 1999-10-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18280
Submission : 2005-04-18
Status : Inactive
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 14686
Submission : 2000-01-26
Status : Inactive
Type : II
Certificate Number : R1-CEP 2007-082 - Rev 02
Issue Date : 2014-07-28
Type : Chemical
Substance Number : 1779
Status : Withdrawn by Holder
NDC Package Code : 53104-7594
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17842
Submission : 2004-11-22
Status : Inactive
Type : II
NDC Package Code : 53104-7594
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19573
Submission : 2006-07-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19901
Submission : 2006-10-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18532
Submission : 2005-07-20
Status : Inactive
Type : II
A Disodium Pamidronate Pentahydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Disodium Pamidronate Pentahydrate, including repackagers and relabelers. The FDA regulates Disodium Pamidronate Pentahydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Disodium Pamidronate Pentahydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Disodium Pamidronate Pentahydrate supplier is an individual or a company that provides Disodium Pamidronate Pentahydrate active pharmaceutical ingredient (API) or Disodium Pamidronate Pentahydrate finished formulations upon request. The Disodium Pamidronate Pentahydrate suppliers may include Disodium Pamidronate Pentahydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Disodium Pamidronate Pentahydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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