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DOSAGE - TABLET;ORAL - EQ 1MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20763
DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20763
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PharmaCompass offers a list of Naratriptan Hydrochloride 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 Naratriptan Hydrochloride manufacturer or Naratriptan Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Naratriptan Hydrochloride manufacturer or Naratriptan Hydrochloride supplier.
PharmaCompass also assists you with knowing the Naratriptan Hydrochloride API Price utilized in the formulation of products. Naratriptan Hydrochloride API Price is not always fixed or binding as the Naratriptan Hydrochloride Price is obtained through a variety of data sources. The Naratriptan Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Naratriptan HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naratriptan HCl, including repackagers and relabelers. The FDA regulates Naratriptan HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naratriptan HCl 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 Naratriptan HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naratriptan HCl supplier is an individual or a company that provides Naratriptan HCl active pharmaceutical ingredient (API) or Naratriptan HCl finished formulations upon request. The Naratriptan HCl suppliers may include Naratriptan HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Naratriptan HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Naratriptan HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Naratriptan HCl active pharmaceutical ingredient (API) in detail. Different forms of Naratriptan HCl DMFs exist exist since differing nations have different regulations, such as Naratriptan HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Naratriptan HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Naratriptan HCl USDMF includes data on Naratriptan HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naratriptan HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Naratriptan HCl 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 Naratriptan HCl Drug Master File in Japan (Naratriptan HCl JDMF) empowers Naratriptan HCl 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 Naratriptan HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Naratriptan HCl 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 Naratriptan HCl 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 Naratriptan HCl Drug Master File in Korea (Naratriptan HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naratriptan HCl. The MFDS reviews the Naratriptan HCl KDMF as part of the drug registration process and uses the information provided in the Naratriptan HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Naratriptan HCl 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 Naratriptan HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Naratriptan HCl suppliers with KDMF on PharmaCompass.
A Naratriptan HCl written confirmation (Naratriptan HCl WC) is an official document issued by a regulatory agency to a Naratriptan HCl manufacturer, verifying that the manufacturing facility of a Naratriptan HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naratriptan HCl APIs or Naratriptan HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Naratriptan HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Naratriptan HCl 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 Naratriptan HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Naratriptan HCl 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 Naratriptan HCl 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 Naratriptan HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naratriptan HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Naratriptan HCl suppliers with NDC on PharmaCompass.
Naratriptan HCl 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 Naratriptan HCl 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 Naratriptan HCl GMP manufacturer or Naratriptan HCl GMP API supplier for your needs.
A Naratriptan HCl CoA (Certificate of Analysis) is a formal document that attests to Naratriptan HCl's compliance with Naratriptan HCl specifications and serves as a tool for batch-level quality control.
Naratriptan HCl CoA mostly includes findings from lab analyses of a specific batch. For each Naratriptan HCl 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.
Naratriptan HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Naratriptan HCl EP), Naratriptan HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naratriptan HCl USP).
