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List of Korea Drug Master Files (KDMF) for glanatec Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Flag Japan
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Korea Kowa Co., Ltd.
2018-11-26
Number 286-1-ND
Chitose Hamari Chemicals,...
Japan
1007-81, Izumisawa, Chito...
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Looking for 223645-67-8 / Ripasudil API manufacturers, exporters & distributors?

Ripasudil manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ripasudil

Synonyms

223645-67-8, K-115 free base, K115 free base, Ripasudil [inn], Ripasudil free base, K-115 (free base)

Cas Number

223645-67-8

Unique Ingredient Identifier (UNII)

11978226XX

About Ripasudil

Ripasudil, as hydrochloride hydrate (K-115), is a specifc Rho-associated coiled-coil containing protein kinase (ROCK) inhibitor used for the treatment of glaucoma and ocular hypertension. It was first approved for treatment in Japan in September 2014. This medication is available in the form of a 0.4% eye drop solution under the brand name Glanatec. Ripasudil is a well tolerated medication that is used when other drugs have been proven to be non-effective or cannot be administered.

glanatec Manufacturers

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

glanatec Suppliers

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

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

glanatec KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a glanatec Drug Master File in Korea (glanatec KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of glanatec. The MFDS reviews the glanatec KDMF as part of the drug registration process and uses the information provided in the glanatec KDMF to evaluate the safety and efficacy of the drug.

After submitting a glanatec KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their glanatec API can apply through the Korea Drug Master File (KDMF).

click here to find a list of glanatec suppliers with KDMF on PharmaCompass.

glanatec Manufacturers | Traders | Suppliers

glanatec Manufacturers, Traders, Suppliers 1
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We have 1 companies offering glanatec

Get in contact with the supplier of your choice:

  1. Chitose Hamari
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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