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List of Drug Master Files (JDMF) for Bosentan Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Megafine Pharma (P) Limited (1)

02 CADILA PHARMACEUTICALS LIMITED. (1)

03 Esteve Huayi Pharmaceutical Co. , Ltd. (1)

04 Glenmark Life Sciences Limited (1)

05 JEIL PHARMACEUTICAL CO. , LTD. (1)

06 Mylan Laboratories Limited (1)

07 Shiratori Pharmaceutical Co., Ltd. (1)

08 Tateyama Kasei Co., Ltd. (1)

09 Viyash Life Sciences Private Limited (1)

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01 Bosentan "Tateyama" (1)

02 Bosentan Hydrate (1)

03 Bosentan hydrate (5)

04 Bosentan hydrate (production only) (1)

05 Bosentan hydrate production-only (1)

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01 China (1)

02 India (4)

03 Japan (2)

04 South Korea (1)

05 U.S.A (1)

227MF10202
Sethna 4th floor 55 Maharshi karve ...
2016-05-10
2015-08-06
Megafine Pharma CB

Chinaplas 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
227MF10204
Sarkhej-Dholka Road, Bhat, Ahmedaba...
2019-03-29
2015-08-10
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227MF10082
Linhai Rd. , Yuecheng District Shao...
2019-05-08
2015-03-12
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227MF10295
Glenmark House, HDO Corporate Build...
2015-12-24
2015-12-24
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227MF10219
343, Sapyeong-daero, Seocho-gu, Seo...
2016-05-10
2015-08-31
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227MF10189
6-11-24 Tsudanuma, Narashino City, ...
2016-05-09
2015-08-03
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226MF10216
1133 Oe, Imizu City, Toyama Prefect...
2016-05-10
2014-11-17
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304MF10002
Plot No. 564/A/22, Road No. 92, Jub...
2022-01-11
2022-01-11
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227MF10197
Plot No. 290, Srivalli's Corporate,...
2021-05-13
2015-08-03
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Looking for 147536-97-8 / Bosentan Hydrate API manufacturers, exporters & distributors?

Bosentan Hydrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Bosentan Hydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Bosentan Hydrate manufacturer or Bosentan Hydrate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bosentan Hydrate manufacturer or Bosentan Hydrate supplier.

PharmaCompass also assists you with knowing the Bosentan Hydrate API Price utilized in the formulation of products. Bosentan Hydrate API Price is not always fixed or binding as the Bosentan Hydrate Price is obtained through a variety of data sources. The Bosentan Hydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Bosentan Hydrate

Synonyms

147536-97-8, Tracleer, Actelion, Bosentan anhydrous, Ro 47-0203, Ro-47-0203

Cas Number

147536-97-8

Unique Ingredient Identifier (UNII)

XUL93R30K2

About Bosentan Hydrate

A sulfonamide and pyrimidine derivative that acts as a dual endothelin receptor antagonist used to manage PULMONARY HYPERTENSION and SYSTEMIC SCLEROSIS.

Bosentan Manufacturers

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.

Bosentan Suppliers

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.

Bosentan JDMF

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.

Bosentan Manufacturers | Traders | Suppliers

Bosentan Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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