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List of Drug Master Files (DMF) of Cenobamate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Biophore India Pharmaceuticals Pvt Ltd (1)

02 Aurobindo Pharma Limited (1)

03 Blank (1)

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01 CENOBAMATE (3)

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01 India (2)

02 Blank (1)

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01 Active (3)

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01 Complete (3)

URL Supplier Web Content
38814
Active
2023-09-26
Complete
2023-11-13
2023-09-15
II
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APICHEM LABORATORIES PRIVATE LTD

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URL Supplier Web Content
38751
Active
2023-09-20
Complete
2023-11-08
2023-09-29
II
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Looking for 913088-80-9 / Cenobamate API manufacturers, exporters & distributors?

Cenobamate manufacturers, exporters & distributors 1

50

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

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

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

API | Excipient name

Cenobamate

Synonyms

Xcopri, 913088-80-9, Cenobamate [inn], Ykp3089, Ykp-3089, P85x70rzws

Cas Number

913088-80-9

Unique Ingredient Identifier (UNII)

P85X70RZWS

About Cenobamate

Cenobamate, or YKP-3089, is an antiepileptic drug developed by SK Pharmaceuticals and used to treat partial onset seizures. The exact mechanism of action has not been described in the literature, though it positively modulates GABAA and inhibits voltage gated sodium channels. Cenobamate was granted FDA approval on 21 November 2019.

Cenobamate Manufacturers

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

Cenobamate Suppliers

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

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

Cenobamate USDMF

A Cenobamate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cenobamate active pharmaceutical ingredient (API) in detail. Different forms of Cenobamate DMFs exist exist since differing nations have different regulations, such as Cenobamate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Cenobamate DMF submitted to regulatory agencies in the US is known as a USDMF. Cenobamate USDMF includes data on Cenobamate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cenobamate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Cenobamate suppliers with USDMF on PharmaCompass.

Cenobamate Manufacturers | Traders | Suppliers

Cenobamate Manufacturers, Traders, Suppliers 1
51

We have 2 companies offering Cenobamate

Get in contact with the supplier of your choice:

  1. Biophore India Pharmaceuticals Pvt Ltd
  2. Aurobindo Pharma Limited
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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