01 1CADILA PHARMACEUTICALS LIMITED.
02 1Esteve Huayi Pharmaceutical Co. , Ltd.
03 1Glenmark Life Sciences Limited
04 1JEIL PHARMACEUTICAL CO. , LTD.
05 1Megafine Pharma (P) Limited
06 1Shiratori Pharmaceutical Co., Ltd.
07 1Tateyama Chemical Co., Ltd.
08 1Tianish Laboratories Private Limited
09 1Viyash Life Sciences Private Limited
01 1Bosentan "Tateyama"
02 1Bosentan Hydrate
03 5Bosentan hydrate
04 1Bosentan hydrate (production only)
05 1Bosentan hydrate production-only
01 1China
02 4India
03 2Japan
04 1South Korea
05 1U.S.A
Bosentan hydrate (for manufacturing purposes only)
Registration Number : 227MF10204
Registrant's Address : Sarkhej-Dholka Road, Bhat, Ahmedabad-382 210, Gujarat, INDIA
Initial Date of Registration : 2015-08-10
Latest Date of Registration : 2019-03-29
Registration Number : 227MF10082
Registrant's Address : Linhai Rd. , Yuecheng District Shaoxing, Zhejiang China
Initial Date of Registration : 2015-03-12
Latest Date of Registration : 2019-05-08
Registration Number : 227MF10295
Registrant's Address : Glenmark House, HDO Corporate Building, Wing A, B. D. Sawant Marg, Chakala, Off Weste...
Initial Date of Registration : 2015-12-24
Latest Date of Registration : 2015-12-24
Registration Number : 227MF10219
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2015-08-31
Latest Date of Registration : 2016-05-10
Registration Number : 227MF10202
Registrant's Address : Sethna 4th floor 55 Maharshi karve road Marine Lines,Mumbai-400002,INDIA
Initial Date of Registration : 2015-08-06
Latest Date of Registration : 2016-05-10
Bosentan hydrate For manufacturing purposes only
Registration Number : 227MF10189
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2015-08-03
Latest Date of Registration : 2016-05-09
Registration Number : 226MF10216
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2014-11-17
Latest Date of Registration : 2024-03-06
Registration Number : 304MF10002
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2022-01-11
Latest Date of Registration : 2022-01-11
Registration Number : 227MF10197
Registrant's Address : Plot No. 290, Srivalli's Corporate, Road No. 6, Kakatiya Hills, Madhapur, Hyderabad-5...
Initial Date of Registration : 2015-08-03
Latest Date of Registration : 2021-05-13
A Bosentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bosentan, including repackagers and relabelers. The FDA regulates Bosentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bosentan 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 Bosentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bosentan supplier is an individual or a company that provides Bosentan active pharmaceutical ingredient (API) or Bosentan finished formulations upon request. The Bosentan suppliers may include Bosentan API manufacturers, exporters, distributors and traders.
click here to find a list of Bosentan 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 Bosentan Drug Master File in Japan (Bosentan JDMF) empowers Bosentan 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 Bosentan JDMF during the approval evaluation for pharmaceutical products. At the time of Bosentan 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 Bosentan suppliers with JDMF on PharmaCompass.
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