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Looking for 143388-64-1 / Naratriptan Hydrochloride API manufacturers, exporters & distributors?

Naratriptan Hydrochloride manufacturers, exporters & distributors 1

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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.

API | Excipient name

Naratriptan Hydrochloride

Synonyms

143388-64-1, Naratriptan hcl, Amerge, Naramig, Gr-85548a, Gr 85548a

Cas Number

143388-64-1

Unique Ingredient Identifier (UNII)

10X8X4P12Z

About Naratriptan Hydrochloride

Naratriptan Hydrochloride is the hydrochloride salt form of naratriptan, a sulfonamide with selective serotonin (5-HT) 1 receptor agonistic activity and anti-migraine property. Naratriptan hydrochloride binds selectively and with high affinity to the 5-HT1D and 5-HT1B receptor subtypes. Activation of these 5-HT1D/B receptors located on intracranial blood vessels leads to vasoconstriction and provides relief of migraine headaches. Naratriptan hydrochloride may also exerts its effect by stimulation of 5-HT1D/1B receptors on sensory nerve endings in the trigeminal system thereby decreasing the release of pro-inflammatory neuropeptides.

Naratriptan Hydrochloride Manufacturers

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

Naratriptan Hydrochloride Suppliers

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

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

Naratriptan Hydrochloride USDMF

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

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

click here to find a list of Naratriptan Hydrochloride suppliers with USDMF on PharmaCompass.

Naratriptan Hydrochloride 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 Naratriptan Hydrochloride Drug Master File in Japan (Naratriptan Hydrochloride JDMF) empowers Naratriptan Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Naratriptan Hydrochloride 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 Hydrochloride suppliers with JDMF on PharmaCompass.

Naratriptan Hydrochloride KDMF

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

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

After submitting a Naratriptan Hydrochloride 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 Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Naratriptan Hydrochloride suppliers with KDMF on PharmaCompass.

Naratriptan Hydrochloride WC

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

click here to find a list of Naratriptan Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Naratriptan Hydrochloride 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 Naratriptan Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Naratriptan Hydrochloride 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 Naratriptan Hydrochloride 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 Naratriptan Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naratriptan Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Naratriptan Hydrochloride suppliers with NDC on PharmaCompass.

Naratriptan Hydrochloride GMP

Naratriptan Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Naratriptan Hydrochloride GMP API supplier for your needs.

Naratriptan Hydrochloride CoA

A Naratriptan Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Naratriptan Hydrochloride's compliance with Naratriptan Hydrochloride specifications and serves as a tool for batch-level quality control.

Naratriptan Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Naratriptan Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Naratriptan Hydrochloride EP), Naratriptan Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naratriptan Hydrochloride 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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