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  • CAPSULE;ORAL - 100MG
  • CAPSULE;ORAL - 25MG
  • CAPSULE;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 68291-97-4 / Zonisamide API manufacturers, exporters & distributors?

Zonisamide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Zonisamide

Synonyms

68291-97-4, Zonegran, 1,2-benzisoxazole-3-methanesulfonamide, 1,2-benzoxazol-3-ylmethanesulfonamide, Exceglan, Excegram

Cas Number

68291-97-4

Unique Ingredient Identifier (UNII)

459384H98V

About Zonisamide

A benzisoxazole and sulfonamide derivative that acts as a CALCIUM CHANNEL blocker. It is used primarily as an adjunctive antiepileptic agent for the treatment of PARTIAL SEIZURES, with or without secondary generalization.

benzo[d]isoxazol-3-ylmethanesulfonamide Manufacturers

A benzo[d]isoxazol-3-ylmethanesulfonamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of benzo[d]isoxazol-3-ylmethanesulfonamide, including repackagers and relabelers. The FDA regulates benzo[d]isoxazol-3-ylmethanesulfonamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. benzo[d]isoxazol-3-ylmethanesulfonamide 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 benzo[d]isoxazol-3-ylmethanesulfonamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

benzo[d]isoxazol-3-ylmethanesulfonamide Suppliers

A benzo[d]isoxazol-3-ylmethanesulfonamide supplier is an individual or a company that provides benzo[d]isoxazol-3-ylmethanesulfonamide active pharmaceutical ingredient (API) or benzo[d]isoxazol-3-ylmethanesulfonamide finished formulations upon request. The benzo[d]isoxazol-3-ylmethanesulfonamide suppliers may include benzo[d]isoxazol-3-ylmethanesulfonamide API manufacturers, exporters, distributors and traders.

click here to find a list of benzo[d]isoxazol-3-ylmethanesulfonamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

benzo[d]isoxazol-3-ylmethanesulfonamide USDMF

A benzo[d]isoxazol-3-ylmethanesulfonamide DMF (Drug Master File) is a document detailing the whole manufacturing process of benzo[d]isoxazol-3-ylmethanesulfonamide active pharmaceutical ingredient (API) in detail. Different forms of benzo[d]isoxazol-3-ylmethanesulfonamide DMFs exist exist since differing nations have different regulations, such as benzo[d]isoxazol-3-ylmethanesulfonamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A benzo[d]isoxazol-3-ylmethanesulfonamide DMF submitted to regulatory agencies in the US is known as a USDMF. benzo[d]isoxazol-3-ylmethanesulfonamide USDMF includes data on benzo[d]isoxazol-3-ylmethanesulfonamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The benzo[d]isoxazol-3-ylmethanesulfonamide USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of benzo[d]isoxazol-3-ylmethanesulfonamide suppliers with USDMF on PharmaCompass.

benzo[d]isoxazol-3-ylmethanesulfonamide JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The benzo[d]isoxazol-3-ylmethanesulfonamide Drug Master File in Japan (benzo[d]isoxazol-3-ylmethanesulfonamide JDMF) empowers benzo[d]isoxazol-3-ylmethanesulfonamide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the benzo[d]isoxazol-3-ylmethanesulfonamide JDMF during the approval evaluation for pharmaceutical products. At the time of benzo[d]isoxazol-3-ylmethanesulfonamide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of benzo[d]isoxazol-3-ylmethanesulfonamide suppliers with JDMF on PharmaCompass.

benzo[d]isoxazol-3-ylmethanesulfonamide KDMF

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

Pharmaceutical companies submit a benzo[d]isoxazol-3-ylmethanesulfonamide Drug Master File in Korea (benzo[d]isoxazol-3-ylmethanesulfonamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of benzo[d]isoxazol-3-ylmethanesulfonamide. The MFDS reviews the benzo[d]isoxazol-3-ylmethanesulfonamide KDMF as part of the drug registration process and uses the information provided in the benzo[d]isoxazol-3-ylmethanesulfonamide KDMF to evaluate the safety and efficacy of the drug.

After submitting a benzo[d]isoxazol-3-ylmethanesulfonamide 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 benzo[d]isoxazol-3-ylmethanesulfonamide API can apply through the Korea Drug Master File (KDMF).

click here to find a list of benzo[d]isoxazol-3-ylmethanesulfonamide suppliers with KDMF on PharmaCompass.

benzo[d]isoxazol-3-ylmethanesulfonamide WC

A benzo[d]isoxazol-3-ylmethanesulfonamide written confirmation (benzo[d]isoxazol-3-ylmethanesulfonamide WC) is an official document issued by a regulatory agency to a benzo[d]isoxazol-3-ylmethanesulfonamide manufacturer, verifying that the manufacturing facility of a benzo[d]isoxazol-3-ylmethanesulfonamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting benzo[d]isoxazol-3-ylmethanesulfonamide APIs or benzo[d]isoxazol-3-ylmethanesulfonamide finished pharmaceutical products to another nation, regulatory agencies frequently require a benzo[d]isoxazol-3-ylmethanesulfonamide WC (written confirmation) as part of the regulatory process.

click here to find a list of benzo[d]isoxazol-3-ylmethanesulfonamide suppliers with Written Confirmation (WC) on PharmaCompass.

benzo[d]isoxazol-3-ylmethanesulfonamide NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing benzo[d]isoxazol-3-ylmethanesulfonamide as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for benzo[d]isoxazol-3-ylmethanesulfonamide API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture benzo[d]isoxazol-3-ylmethanesulfonamide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain benzo[d]isoxazol-3-ylmethanesulfonamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a benzo[d]isoxazol-3-ylmethanesulfonamide NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of benzo[d]isoxazol-3-ylmethanesulfonamide suppliers with NDC on PharmaCompass.

benzo[d]isoxazol-3-ylmethanesulfonamide GMP

benzo[d]isoxazol-3-ylmethanesulfonamide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of benzo[d]isoxazol-3-ylmethanesulfonamide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right benzo[d]isoxazol-3-ylmethanesulfonamide GMP manufacturer or benzo[d]isoxazol-3-ylmethanesulfonamide GMP API supplier for your needs.

benzo[d]isoxazol-3-ylmethanesulfonamide CoA

A benzo[d]isoxazol-3-ylmethanesulfonamide CoA (Certificate of Analysis) is a formal document that attests to benzo[d]isoxazol-3-ylmethanesulfonamide's compliance with benzo[d]isoxazol-3-ylmethanesulfonamide specifications and serves as a tool for batch-level quality control.

benzo[d]isoxazol-3-ylmethanesulfonamide CoA mostly includes findings from lab analyses of a specific batch. For each benzo[d]isoxazol-3-ylmethanesulfonamide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

benzo[d]isoxazol-3-ylmethanesulfonamide may be tested according to a variety of international standards, such as European Pharmacopoeia (benzo[d]isoxazol-3-ylmethanesulfonamide EP), benzo[d]isoxazol-3-ylmethanesulfonamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (benzo[d]isoxazol-3-ylmethanesulfonamide USP).

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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