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

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Handok Co., Ltd.
2021-07-29
20210729-209-J-1082
Nippon Rika Co., Ltd. Ash...
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610, Yanada-cho, Ashikaga...
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Handok Co., Ltd.
2021-08-20
20210820-209-J-1095
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Looking for 50847-11-5 / Ibudilast API manufacturers, exporters & distributors?

Ibudilast manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ibudilast

Synonyms

50847-11-5, Ketas, Kc-404, Mn-166, Ibudilastum, Ke tas

Cas Number

50847-11-5

Unique Ingredient Identifier (UNII)

M0TTH61XC5

About Ibudilast

Ibudilast is an orally bioavailable inhibitor of cyclic nucleotide phosphodiesterase (PDE), mainly PDE-3, -4, -10, and -11, with anti-(neuro)inflammatory, vasorelaxant, bronchodilator, analgesic, neuroprotective and potential anti-tumor activities. Ibudilast (IBD) is able to cross the blood-brain barrier (BBB). Upon administration, IBD exerts its potential anti-tumor activity against glioblastoma multiforme (GBM) cells by inhibiting PDE-4 and the pro-inflammatory cytokine macrophage migration inhibitory factor (MIF), which results in a decrease in MIF, its receptor CD74, and AKT expression, and attenuates the immunosuppressive properties of monocytic myeloid-derived suppressor cells (MDSCs) and reduces T-regulatory cells (Tregs). This causes GBM cell apoptosis and inhibits GBM cell proliferation. In addition, IBD reduces, through its inhibitory effect on various PDEs, the production of certain pro-inflammatory cytokines, such as interleukin-6 (IL-6), IL- 1beta, leukotriene B4, and tumor necrosis factor-alpha (TNF-a). IBD also upregulates the anti-inflammatory cytokine (IL-10), and promotes the production of neurotrophic factors, such as brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), and neurotrophin-4 (NT-4). It also blocks toll-like receptor-4 (TLR-4), inhibits nitric oxide (NO) synthesis and reduces the level of reactive oxygen species (ROS). It also prevents platelet aggregation, causes cerebral vasodilation, bronchial smooth muscle relaxation, and improves cerebral blood flow. In addition, IBD attenuates the PDE-mediated activation of glial cells and abrogates PDE-mediated neuroinflammation and neurodegeneration. MIF is secreted by cancer stem cells (CSCs) and is highly expressed within GBM and plays a key role in tumor cell proliferation. Co-expression of MIF and CD74 in GBM is associated with poor patient survival.

Ibudilast Manufacturers

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

Ibudilast Suppliers

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

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

Ibudilast KDMF

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

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

After submitting a Ibudilast 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 Ibudilast API can apply through the Korea Drug Master File (KDMF).

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

Ibudilast Manufacturers | Traders | Suppliers

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

Get in contact with the supplier of your choice:

  1. Nippon Rikagaku Yakuhin
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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