Synopsis
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KDMF
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FDF
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Data Compilation #PharmaFlow
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API SUPPLIERS
Inke S.A: APIs manufacturing plant.
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ASMF
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
EU-WC
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Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
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 ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
About the Company : Unimark Remedies Ltd is a leading API manufacturer with over 18 years of excellence, now fully owned by Shamrock Pharma Group. We provide affordable generic APIs for local and glob...
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DOSAGE - FILM;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 205394
DOSAGE - TABLET;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 20864
DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20864
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 20865
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20865
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Rizatriptan Benzoate 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 Rizatriptan Benzoate manufacturer or Rizatriptan Benzoate supplier for your needs.
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PharmaCompass also assists you with knowing the Rizatriptan Benzoate API Price utilized in the formulation of products. Rizatriptan Benzoate API Price is not always fixed or binding as the Rizatriptan Benzoate Price is obtained through a variety of data sources. The Rizatriptan Benzoate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A MAXALT-MLT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MAXALT-MLT, including repackagers and relabelers. The FDA regulates MAXALT-MLT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MAXALT-MLT 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 MAXALT-MLT manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A MAXALT-MLT supplier is an individual or a company that provides MAXALT-MLT active pharmaceutical ingredient (API) or MAXALT-MLT finished formulations upon request. The MAXALT-MLT suppliers may include MAXALT-MLT API manufacturers, exporters, distributors and traders.
click here to find a list of MAXALT-MLT suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A MAXALT-MLT DMF (Drug Master File) is a document detailing the whole manufacturing process of MAXALT-MLT active pharmaceutical ingredient (API) in detail. Different forms of MAXALT-MLT DMFs exist exist since differing nations have different regulations, such as MAXALT-MLT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MAXALT-MLT DMF submitted to regulatory agencies in the US is known as a USDMF. MAXALT-MLT USDMF includes data on MAXALT-MLT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MAXALT-MLT USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MAXALT-MLT 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 MAXALT-MLT Drug Master File in Japan (MAXALT-MLT JDMF) empowers MAXALT-MLT 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 MAXALT-MLT JDMF during the approval evaluation for pharmaceutical products. At the time of MAXALT-MLT 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 MAXALT-MLT suppliers with JDMF on PharmaCompass.
A MAXALT-MLT CEP of the European Pharmacopoeia monograph is often referred to as a MAXALT-MLT Certificate of Suitability (COS). The purpose of a MAXALT-MLT CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MAXALT-MLT EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MAXALT-MLT to their clients by showing that a MAXALT-MLT CEP has been issued for it. The manufacturer submits a MAXALT-MLT CEP (COS) as part of the market authorization procedure, and it takes on the role of a MAXALT-MLT CEP holder for the record. Additionally, the data presented in the MAXALT-MLT CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MAXALT-MLT DMF.
A MAXALT-MLT CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MAXALT-MLT CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of MAXALT-MLT suppliers with CEP (COS) on PharmaCompass.
A MAXALT-MLT written confirmation (MAXALT-MLT WC) is an official document issued by a regulatory agency to a MAXALT-MLT manufacturer, verifying that the manufacturing facility of a MAXALT-MLT active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting MAXALT-MLT APIs or MAXALT-MLT finished pharmaceutical products to another nation, regulatory agencies frequently require a MAXALT-MLT WC (written confirmation) as part of the regulatory process.
click here to find a list of MAXALT-MLT 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 MAXALT-MLT as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for MAXALT-MLT 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 MAXALT-MLT 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 MAXALT-MLT and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MAXALT-MLT NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of MAXALT-MLT suppliers with NDC on PharmaCompass.
MAXALT-MLT 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 MAXALT-MLT 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 MAXALT-MLT GMP manufacturer or MAXALT-MLT GMP API supplier for your needs.
A MAXALT-MLT CoA (Certificate of Analysis) is a formal document that attests to MAXALT-MLT's compliance with MAXALT-MLT specifications and serves as a tool for batch-level quality control.
MAXALT-MLT CoA mostly includes findings from lab analyses of a specific batch. For each MAXALT-MLT 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.
MAXALT-MLT may be tested according to a variety of international standards, such as European Pharmacopoeia (MAXALT-MLT EP), MAXALT-MLT JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MAXALT-MLT USP).
