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List of Drug Master Files (KDMF) for Perampanel Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 FIS Fabbrica Italiana Sintetici SpA (1)

02 Kashima Plant of Eisai Co., Ltd. (1)

03 MSN Organics Private Limited (2)

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01 Aging Life Science Co., Ltd. (1)

02 Kookjeon Pharmaceutical Co., Ltd. (1)

03 Korea Eisai Co., Ltd. (2)

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01 Perampanel (3)

02 Perampanel (micronized) (1)

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01 India (2)

02 Italy (1)

03 Japan (1)

URL Supplier Web Content
Korea Eisai Co., Ltd.
2015-03-27
Number 3834-4-ND
Kashima Plant of Eisai Co...
Japan
22 Sunayama, Kamisu-shi, ...
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Korea Eisai Co., Ltd.
2020-06-25
Number 140-7-ND
FIS Fabbrica Italiana Sin...
Italy
Viale Milano, 26 - 36075 ...
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Aging Life Science Co., Ltd.
2021-03-17
Number 434-31-ND
MSN Organics Private Limi...
India
Sy.No.224/A, Bibinagar (V...
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Kookjeon Pharmaceutical Co., Ltd.
2020-11-25
Wed173-29-ND
MSN Organics Private Limi...
India
Sy. No. 224/A, Bibinagar(...
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Looking for 380917-97-5 / Perampanel API manufacturers, exporters & distributors?

Perampanel manufacturers, exporters & distributors 1

83

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

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

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

API | Excipient name

Perampanel

Synonyms

380917-97-5, Fycompa, E2007, Er-155055-90, E-2007, 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one

Cas Number

380917-97-5

Unique Ingredient Identifier (UNII)

H821664NPK

About Perampanel

Perampanel is an orally active, non-competitive, and selective alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor antagonist, with anti-epileptic activity. Although the mechanism of action through which perampanel exerts its antiepileptic effect has not been fully elucidated, this agent antagonizes the AMPA subtype of the excitatory glutamate receptor found on postsynaptic neurons in the central nervous system (CNS). This antagonistic action prevents AMPA receptor activation by glutamate and results in the inhibition of neuronal excitation, repetitive neuronal firing, and the stabilization of hyper-excited neural membranes. Glutamate, the primary excitatory neurotransmitter in the CNS, plays an important role in various neurological disorders caused by neuronal hyperexcitation.

Perampanel Manufacturers

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

Perampanel Suppliers

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

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

Perampanel KDMF

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

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

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

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

Perampanel Manufacturers | Traders | Suppliers

Perampanel Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Perampanel

Get in contact with the supplier of your choice:

  1. Eisai
  2. F.I.S. Fabbrica Italiana Sintetici
  3. MSN Laboratories
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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