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 1Apeloa Pharmaceutical
03 1Asahi Vet Japan Co Ltd
04 1Grand Health Industrial Co Ltd
05 1Hebei Shengxue Dacheng Pharmaceutical Co
06 1Hebei Veyong Pharmaceutical
07 1Jiangsu SEL Biochem
08 1Kaken Pharmaceuticals
09 1LIFECOME BIOCHEMISTRY
10 4Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
11 1Meiji Seika Pharma
12 1SNA Healthcare
13 1Tocopharm Co. Limited
14 1Xellia Pharmaceuticals ApS
15 1Zhejiang Shenghua Biok Biology
16 3Blank
01 12China
02 1Denmark
03 1India
04 3Japan
05 1Netherlands
06 3Blank
01 1Active
02 2Inactive
03 18Blank
01 2Expired
02 7Valid
03 3Withdrawn by Holder
04 9Blank
01 21Blank
01 21Blank
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-16
Pay. Date : 2012-11-15
DMF Number : 13362
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 2002-241 - Rev 03
Issue Date : 2018-12-07
Type : Chemical
Substance Number : 320
Status : Valid
NDC Package Code : 45932-0003
Start Marketing Date : 1998-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 13289
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 : 13301
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : R1-CEP 2009-144 - Rev 01
Issue Date : 2019-02-21
Type : Chemical
Substance Number : 320
Status : Valid
Certificate Number : R1-CEP 2011-372 - Rev 03
Issue Date : 2022-11-03
Type : Chemical
Substance Number : 320
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2005-166 - Rev 01
Issue Date : 2023-02-16
Type : Chemical
Substance Number : 320
Status : Valid
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : R1-CEP 2013-257 - Rev 01
Issue Date : 2020-09-01
Type : Chemical
Substance Number : 320
Status : Valid
Certificate Number : R1-CEP 2004-258 - Rev 03
Issue Date : 2020-04-30
Type : Chemical
Substance Number : 320
Status : Valid
Certificate Number : R1-CEP 2001-198 - Rev 00
Issue Date : 2011-04-15
Type : Chemical
Substance Number : 320
Status : Valid
A colistin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of colistin, including repackagers and relabelers. The FDA regulates colistin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. colistin 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 colistin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A colistin supplier is an individual or a company that provides colistin active pharmaceutical ingredient (API) or colistin finished formulations upon request. The colistin suppliers may include colistin API manufacturers, exporters, distributors and traders.
click here to find a list of colistin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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