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CEP/COS
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VMF
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Canada
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South Africa
DRUG PRODUCT COMPOSITIONS0
FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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API SUPPLIERS
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USDMF
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-15
Pay. Date : 2018-11-26
DMF Number : 33256
Submission : 2018-10-09
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-12
Pay. Date : 2019-06-11
DMF Number : 31298
Submission : 2017-01-04
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18197
Submission : 2005-03-23
Status :
Type : II
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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Date of Issue : 2022-07-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0150
Address of the Firm : R. S. No. 50/1, Mukteswarapuram (V), Jaggalahpet (M), Krishna -District- 521175,...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0195
Address of the Firm : Plot No. 3102/B, GIDC, Industrial Estate, Ankleshwar-393 002, Bharuch, Gujarat I...
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
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DOSAGE - CAPSULE;ORAL - 100MG
USFDA APPLICATION NUMBER - 20789
DOSAGE - CAPSULE;ORAL - 25MG
USFDA APPLICATION NUMBER - 20789
DOSAGE - CAPSULE;ORAL - 50MG **Federal Regist...DOSAGE - CAPSULE;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20789
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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.
A Zonisamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zonisamide, including repackagers and relabelers. The FDA regulates Zonisamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zonisamide 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 Zonisamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zonisamide supplier is an individual or a company that provides Zonisamide active pharmaceutical ingredient (API) or Zonisamide finished formulations upon request. The Zonisamide suppliers may include Zonisamide API manufacturers, exporters, distributors and traders.
click here to find a list of Zonisamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zonisamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Zonisamide active pharmaceutical ingredient (API) in detail. Different forms of Zonisamide DMFs exist exist since differing nations have different regulations, such as Zonisamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zonisamide DMF submitted to regulatory agencies in the US is known as a USDMF. Zonisamide USDMF includes data on Zonisamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zonisamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zonisamide suppliers with USDMF on PharmaCompass.
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 Zonisamide Drug Master File in Japan (Zonisamide JDMF) empowers Zonisamide 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 Zonisamide JDMF during the approval evaluation for pharmaceutical products. At the time of Zonisamide 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 Zonisamide suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Zonisamide Drug Master File in Korea (Zonisamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zonisamide. The MFDS reviews the Zonisamide KDMF as part of the drug registration process and uses the information provided in the Zonisamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zonisamide 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 Zonisamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zonisamide suppliers with KDMF on PharmaCompass.
A Zonisamide written confirmation (Zonisamide WC) is an official document issued by a regulatory agency to a Zonisamide manufacturer, verifying that the manufacturing facility of a Zonisamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zonisamide APIs or Zonisamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Zonisamide WC (written confirmation) as part of the regulatory process.
click here to find a list of Zonisamide suppliers with Written Confirmation (WC) on PharmaCompass.
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 Zonisamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zonisamide API and other APIs are published in this directory by the FDA.
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 Zonisamide 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.
The NDC directory also contains data on finished compounded human drug products that contain Zonisamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zonisamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zonisamide suppliers with NDC on PharmaCompass.
Zonisamide 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 Zonisamide 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 Zonisamide GMP manufacturer or Zonisamide GMP API supplier for your needs.
A Zonisamide CoA (Certificate of Analysis) is a formal document that attests to Zonisamide's compliance with Zonisamide specifications and serves as a tool for batch-level quality control.
Zonisamide CoA mostly includes findings from lab analyses of a specific batch. For each Zonisamide 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.
Zonisamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Zonisamide EP), Zonisamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zonisamide USP).
