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

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01 DAE HE CHEMICAL CO., LTD. (1)

02 Daiwa Pharmaceutical Co., Ltd. (2)

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01 Japanese Pharmacopoeia tranilast (production only) (1)

02 Outsiders regulations tranilast (production only) (1)

03 Tranilast (1)

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01 India (1)

02 Japan (1)

03 South Korea (1)

URL Supplier Web Content
219MF10259
1 RA 301, SHIHWA INDUSTRIAL COMPLEX...
2007-08-06
2007-08-06
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URL Supplier Web Content
217MF10501
2-3-5 Shimookui, Toyama City, Toyam...
2006-11-21
2005-09-06
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URL Supplier Web Content
225MF10057
2-3-5 Shimookui, Toyama City, Toyam...
2013-03-12
2013-03-12
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Looking for 53902-12-8 / Tranilast API manufacturers, exporters & distributors?

Tranilast manufacturers, exporters & distributors 1

73

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

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

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

API | Excipient name

Tranilast

Synonyms

53902-12-8, Trans-tranilast, Rizaben, 70806-55-2, Tranilastum, Mk 341

Cas Number

53902-12-8

Unique Ingredient Identifier (UNII)

HVF50SMY6E

About Tranilast

Tranilast is an antiallergic drug developed by Kissei Pharmaceuticals. In 1982, it was approved in Japan and South Korea for the management of bronchial asthma. Indications for keloid and hypertrophic scar were added in 1993. It has been used for the treatment of allergic disorders such as asthma, allergic rhinitis and atopic dermatitis.

Tranilast Manufacturers

A Tranilast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tranilast, including repackagers and relabelers. The FDA regulates Tranilast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tranilast API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Tranilast Suppliers

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

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

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

Tranilast Manufacturers | Traders | Suppliers

Tranilast Manufacturers, Traders, Suppliers 1
91

We have 3 companies offering Tranilast

Get in contact with the supplier of your choice:

  1. Daehe Chemical
  2. Daiwa Pharmaceuticals
  3. Sato Yakuhin Kogyo Co., Ltd
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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