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

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01 Dr. Reddy's Laboratories (1)

02 Minakem (formerly Delmar Chemicals) (1)

03 Ami Lifesciences Private Limited (1)

04 Aurobindo Pharma Limited (1)

05 Bial (2)

06 CTX Lifesciences (1)

07 Chunghwa Chemical Synthesis & Biotech (1)

08 Dasami Lab (2)

09 Jubilant Generics (1)

10 Lupin Ltd (1)

11 MSN Laboratories (1)

12 Shanghai Pharma Group (1)

13 Tianjin Weijie Pharmaceutical Co., Ltd. (1)

14 ZCL Chemicals Limited (1)

15 Blank (1)

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01 ESLICARBAZEPINE ACETATE (15)

02 ESLICARBAZEPINE ACETATE (PROCESS-II) (1)

03 ESLICARBAZEPINE ACETATE DRUG SUBSTANCE (1)

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01 Canada (1)

02 China (2)

03 India (10)

04 Portugal (2)

05 Taiwan (1)

06 Blank (1)

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01 Active (16)

02 Inactive (1)

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01 Complete (9)

02 Blank (8)

31791
Active
2017-06-05
Complete
2018-07-27
2017-06-09
II
Minakem Delmar

Biotechgate Digital

Not Confirmed

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URL Supplier Web Content
26622
Active
2012-11-19
N/A
II
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URL Supplier Web Content
22026
Active
2008-09-26
N/A
II
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URL Supplier Web Content
30222
Active
2016-01-29
Complete
2016-09-30
2016-08-24
II
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URL Supplier Web Content
31896
Active
2017-08-24
Complete
2017-09-29
2017-08-04
II
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URL Supplier Web Content
26927
Active
2013-03-26
Complete
2016-10-21
2016-06-16
II
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URL Supplier Web Content
31500
Active
2017-04-03
Complete
2017-05-16
2017-04-12
II
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URL Supplier Web Content
32721
Active
2018-04-30
N/A
II
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URL Supplier Web Content
33028
Active
2018-08-09
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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.

Eslicarbazepine Acetate Manufacturers

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

Eslicarbazepine Acetate Suppliers

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

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

Eslicarbazepine Acetate USDMF

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

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

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

Eslicarbazepine Acetate Manufacturers | Traders | Suppliers

Eslicarbazepine Acetate Manufacturers, Traders, Suppliers 1
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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