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

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01 HANMI FINE CHEMICAL CO. , LTD. (1)

02 HL Genomics (1)

03 Osaka Synthetic Organic Chemistry Institute Co., Ltd. (1)

04 Ryoto Fine Co., Ltd. (1)

05 UBE Co., Ltd. (1)

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01 Bepotastine besilate (2)

02 Bepotastine besilate (production only) (1)

03 Besylate bepotastine (1)

04 Japanese Pharmacopoeia bepotastine besilate production dedicated (1)

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01 Japan (3)

02 South Korea (2)

URL Supplier Web Content
229MF10032
57, Gyeongje-ro, Siheung-si, Gyeong...
2023-06-21
2017-02-08
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229MF10070
1552, Bogaewonsam-ro, Wonsam-myeon,...
2017-04-04
2017-04-04
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229MF10016
1-1-2 Nishinomiyahama, Nishinomiya ...
2020-07-06
2017-01-25
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223MF10109
1410 Takada, Kashiwa City, Chiba Pr...
2012-05-15
2011-07-15
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217MF10442
96, 1978 Kogushi, Ube City, Yamaguc...
2023-09-13
2005-08-19
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Looking for 190786-44-8 / Bepotastine API manufacturers, exporters & distributors?

Bepotastine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Bepotastine 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 Bepotastine manufacturer or Bepotastine supplier for your needs.

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

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

API | Excipient name

Bepotastine

Synonyms

190786-44-8, Bepotastine besylate, Bepreve, Talion, Betotastine besilate, Bepotastine benzenesulfonate

Cas Number

190786-44-8

Unique Ingredient Identifier (UNII)

6W18MO1QR3

Bepotastine Manufacturers

A Bepotastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bepotastine, including repackagers and relabelers. The FDA regulates Bepotastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bepotastine 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 Bepotastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Bepotastine Suppliers

A Bepotastine supplier is an individual or a company that provides Bepotastine active pharmaceutical ingredient (API) or Bepotastine finished formulations upon request. The Bepotastine suppliers may include Bepotastine API manufacturers, exporters, distributors and traders.

click here to find a list of Bepotastine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Bepotastine 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 Bepotastine Drug Master File in Japan (Bepotastine JDMF) empowers Bepotastine 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 Bepotastine JDMF during the approval evaluation for pharmaceutical products. At the time of Bepotastine 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 Bepotastine suppliers with JDMF on PharmaCompass.

Bepotastine Manufacturers | Traders | Suppliers

Bepotastine Manufacturers, Traders, Suppliers 1
99

We have 5 companies offering Bepotastine

Get in contact with the supplier of your choice:

  1. Hanmi Pharmaceutical
  2. HL Genomics
  3. Osaka Synthetic Chemical Laboratories
  4. Ryoto Fine Co
  5. UBE Industries
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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