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 1Gador SA
11 1Hospira, Inc.
12 1JPN Pharma
13 1SNA Healthcare
14 1Sun Pharmaceutical Industries Limited
15 1Teva Pharmaceutical Industries
16 1Trifarma
17 1Vaishali Pharma Ltd
01 1Argentina
02 1Canada
03 7India
04 2Israel
05 3Italy
06 1Netherlands
07 1Poland
08 1Sweden
09 2U.S.A
01 2Active
02 7Inactive
03 10Blank
01 1Valid
02 1Withdrawn by Holder
03 17Blank
01 1228MF10223
02 18Blank
01 1WC-0159
02 18Blank
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.
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 : 19573
Submission : 2006-07-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18532
Submission : 2005-07-20
Status : Inactive
Type : II
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