01 1Esteve Quimica, S. A.
02 1Guilin Hwasun Pharmaceutical Co. , Ltd.
03 1Pharmacostech CO. ,LTD
04 1Quimica Syntetica S. A.
05 1SHOUGUANG FUKANG PHARMACEUTICAL CO. , LTD.
06 1Sanyo Chemical Research Institute Co., Ltd.
07 1TAPI Croatia Industries Ltd.
08 1Zhejiang Huayi Pharmaceutical Co. , Ltd.
09 1Zhejiang Jinhua Comba Bio-pharm. Co. , Ltd.
01 6Omeprazole
02 1Omeprazole "Teva"
03 1Omeprazole (production only)
04 1Blank
01 4China
02 1Croatia
03 1Gabon
04 1South Korea
05 2Spain
Registration Number : 225MF10073
Registrant's Address : No. 89, 1st street, Lingbei Road, Lingchuan, Guilin, Guangxi, PR China
Initial Date of Registration : 2013-04-18
Latest Date of Registration : 2013-04-18
Registration Number : 302MF10128
Registrant's Address : 47, Jeyakdanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Republic of Korea
Initial Date of Registration : 2020-10-16
Latest Date of Registration : 2020-10-16
Registration Number : 225MF10127
Registrant's Address : Prudnicka cesta 54, Savski Marof, County Brdovec 10291 Prigorje Brdovecko, Croatia
Initial Date of Registration : 2013-07-02
Latest Date of Registration : 2013-07-02
Registration Number : 218MF10191
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2006-02-08
Latest Date of Registration : 2021-11-10
Registration Number : 226MF10185
Registrant's Address : NORTH-EAST OF DONGWAIHUAN ROAD, DONGCHENG INDUSTRIAL AREA, SHOUGUANG CITY, SHANDONG, ...
Initial Date of Registration : 2014-09-30
Latest Date of Registration : 2014-09-30
Omeprazole (for manufacturing only)
Registration Number : 219MF10283
Registrant's Address : Torre Esteve, Pg. de la Zona Franca, 109, 4th floor, 08038 Barcelona - Spain
Initial Date of Registration : 2007-09-10
Latest Date of Registration : 2020-06-08
Registration Number : 219MF10369
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2007-12-13
Latest Date of Registration : 2007-12-13
OMEPRAZOLE-C EXCLUSIVE USE FOR MANUFACTURE
Registration Number : 306MF10007
Registrant's Address : No. 15 Shuangfeng Road, Fotang, Yiwu, Zhejiang 322002, China
Initial Date of Registration : 2024-01-17
Latest Date of Registration : 2024-01-17
Registration Number : 227MF10109
Registrant's Address : No. 288 Jinqu Road, Jinhua City, Zhejiang, P. R. China
Initial Date of Registration : 2015-04-09
Latest Date of Registration : 2015-04-09
A Omeprazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omeprazole, including repackagers and relabelers. The FDA regulates Omeprazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omeprazole 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 Omeprazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Omeprazole supplier is an individual or a company that provides Omeprazole active pharmaceutical ingredient (API) or Omeprazole finished formulations upon request. The Omeprazole suppliers may include Omeprazole API manufacturers, exporters, distributors and traders.
click here to find a list of Omeprazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Omeprazole Drug Master File in Japan (Omeprazole JDMF) empowers Omeprazole API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Omeprazole JDMF during the approval evaluation for pharmaceutical products. At the time of Omeprazole JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Omeprazole suppliers with JDMF on PharmaCompass.
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