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List of Korea Drug Master Files (KDMF) for 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Masung LS Co., Ltd.
2022-11-24
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CTX Life Sciences Pvt. Lt...
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  • TABLET;ORAL - 200MG
  • TABLET;ORAL - 400MG
  • TABLET;ORAL - 600MG
  • TABLET;ORAL - 800MG

Looking for 236395-14-5 / Eslicarbazepine Acetate API manufacturers, exporters & distributors?

Eslicarbazepine Acetate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Eslicarbazepine Acetate

Synonyms

236395-14-5, Bia 2-093, Zebinix, Exalief, Aptiom, Stedesa

Cas Number

236395-14-5

Unique Ingredient Identifier (UNII)

BEA68ZVB2K

About Eslicarbazepine Acetate

Eslicarbazepine acetate (ESL) is an anticonvulsant medication approved for use in Europe, the United States and Canada as an adjunctive therapy for partial-onset seizures that are not adequately controlled with conventional therapy. Eslicarbazepine acetate is a prodrug that is rapidly converted to eslicarbazepine, the primary active metabolite in the body. Eslicarbazepine's mechanism of action is not well understood, but it is known that it does exert anticonvulsant activity by inhibiting repeated neuronal firing and stabilizing the inactivated state of voltage-gated sodium channels, thus preventing their return to the activated state during which seizure activity can occur. Eslicarbazepine acetate is marketed as Aptiom in North America and Zebinix or Exalief in Europe. It is available in 200, 400, 600, or 800mg tablets that are taken once daily, with or without food. Eslicarbazepine acetate is associated with numerous side effects including dizziness, drowsiness, nausea, vomiting, diarrhea, headache, aphasia, lack of concentration, psychomotor retardation, speech disturbances, ataxia, depression and hyponatremia. It is recommended that patients taking eslicarbazepine acetate be monitored for suicidality.

10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide Manufacturers

A 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide, including repackagers and relabelers. The FDA regulates 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide 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 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide Suppliers

A 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide supplier is an individual or a company that provides 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide active pharmaceutical ingredient (API) or 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide finished formulations upon request. The 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide suppliers may include 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide API manufacturers, exporters, distributors and traders.

click here to find a list of 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide KDMF

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

Pharmaceutical companies submit a 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide Drug Master File in Korea (10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide. The MFDS reviews the 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide KDMF as part of the drug registration process and uses the information provided in the 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide KDMF to evaluate the safety and efficacy of the drug.

After submitting a 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide 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 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide suppliers with KDMF on PharmaCompass.

10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide Manufacturers | Traders | Suppliers

10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide Manufacturers, Traders, Suppliers 1
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We have 3 companies offering 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide

Get in contact with the supplier of your choice:

  1. CTX Lifesciences
  2. Lonza Group
  3. Lupin 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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