Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
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01 1Laboratorium Ofichem B.V
02 1ChemWerth Inc
03 1Jai Radhe Sales
04 1Polfa Tarchomin
05 1TAPI Technology & API Services
06 1JPN Pharma
07 1Apotex Pharmachem
08 2Bioindustria L.I.M. Spa
09 2Cipla
10 1Fresenius Kabi AB Brunna
11 1Fuan Pharmaceutical
12 1Gador SA
13 1Hospira, Inc.
14 1Strem Chemicals
15 1Sun Pharmaceutical Industries Limited
16 1Teva Pharmaceutical Industries
17 1Trifarma
18 1Vaishali Pharma Ltd
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01 1Argentina
02 1Canada
03 1China
04 6India
05 2Israel
06 3Italy
07 1Netherlands
08 1Poland
09 1Sweden
10 3U.S.A
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01 2Active
02 7Inactive
03 11Blank
01 1Valid
02 1Withdrawn by Holder
03 18Blank
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01 1228MF10223
02 19Blank
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01 1WC-0159
02 19Blank
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01 150711-0003
02 162675-0718
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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 : 2026-12-31
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
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
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 : 18532
Submission : 2005-07-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19573
Submission : 2006-07-03
Status : Inactive
Type : II
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PharmaCompass offers a list of Pamidronate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Pamidronate manufacturer or Pamidronate supplier for your needs.
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A APD manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of APD, including repackagers and relabelers. The FDA regulates APD manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. APD 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 APD supplier is an individual or a company that provides APD active pharmaceutical ingredient (API) or APD finished formulations upon request. The APD suppliers may include APD API manufacturers, exporters, distributors and traders.
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We have 18 companies offering APD
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