01 1Hamari Pharmaceuticals Co., Ltd.
02 1Hetero Labs Limited
03 1Natco Pharma Limited.
04 1SUVEN LIFE SCIENCE LIMITED.
05 1Shin Poong Pharm. Co. , Ltd.
06 1Sumitomo Chemical Co., Ltd.
07 1TAPI Croatia Industries Ltd.
01 1Imatinib Mesylate Alpha Form
02 3Imatinib mesylate
03 1Imatinib mesylate "Teva"
04 1Imatinib mesylateα2Mold
05 1Outsiders regulations mesylate dimetotiazine (production only)
01 1Croatia
02 3India
03 2Japan
04 1South Korea
Dimethothazine mesylate (for manufacturing only)
Registration Number : 217MF11146
Registrant's Address : 1-4-29 Shibashima, Higashiyodogawa-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2007-12-13
Registration Number : 225MF10046
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Andhra Prad...
Initial Date of Registration : 2013-03-05
Latest Date of Registration : 2013-03-05
Registration Number : 225MF10060
Registrant's Address : Natco House, Road No. 2, Banjara Hills,Hyderabad 500034, Telangana, India
Initial Date of Registration : 2013-03-14
Latest Date of Registration : 2014-01-08
Registration Number : 224MF10188
Registrant's Address : Prudnicka cesta 54, Savski Marof, County Brdovec 10291 Prigorje Brdovecko, Croatia
Initial Date of Registration : 2012-09-03
Latest Date of Registration : 2015-05-14
Registration Number : 225MF10044
Registrant's Address : 161, Yeoksam-ro, Gangnam-gu, Seoul, 135-925, Korea
Initial Date of Registration : 2013-03-05
Latest Date of Registration : 2013-03-05
Registration Number : 224MF10163
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2012-08-16
Latest Date of Registration : 2013-06-21
Registration Number : 225MF10120
Registrant's Address : Serene Chambers, Road #5, Avenue-7, Banjara Hills, Hyderabad-500034, A. P. ,INDIA
Initial Date of Registration : 2013-06-18
Latest Date of Registration : 2013-06-18
A Imatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Imatinib, including repackagers and relabelers. The FDA regulates Imatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Imatinib 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 Imatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Imatinib supplier is an individual or a company that provides Imatinib active pharmaceutical ingredient (API) or Imatinib finished formulations upon request. The Imatinib suppliers may include Imatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Imatinib 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 Imatinib Drug Master File in Japan (Imatinib JDMF) empowers Imatinib 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 Imatinib JDMF during the approval evaluation for pharmaceutical products. At the time of Imatinib 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 Imatinib suppliers with JDMF on PharmaCompass.
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