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  • INJECTABLE;SUBCUTANEOUS - EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
  • INJECTABLE;SUBCUTANEOUS - EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
  • TABLET;ORAL - EQ 100MG BASE
  • TABLET;ORAL - EQ 25MG BASE
  • TABLET;ORAL - EQ 50MG BASE
  • SYSTEM;IONTOPHORESIS - EQ 6.5MG BASE/4HR
  • POWDER;NASAL - EQ 11MG BASE
  • SPRAY;NASAL - 20MG/SPRAY
  • SPRAY;NASAL - 5MG/SPRAY
  • TABLET;ORAL - 500MG;EQ 85MG BASE
  • TABLET;ORAL - 60MG;EQ 10MG BASE
  • INJECTABLE;SUBCUTANEOUS - EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
  • INJECTABLE;SUBCUTANEOUS - EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Looking for 103628-46-2 / Sumatriptan API manufacturers, exporters & distributors?

Sumatriptan manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Sumatriptan

Synonyms

103628-46-2, Sumatran, Sumax, Imigran, Imitrex, Sumatriptanum

Cas Number

103628-46-2

Unique Ingredient Identifier (UNII)

8R78F6L9VO

About Sumatriptan

A serotonin agonist that acts selectively at 5HT1 receptors. It is used in the treatment of MIGRAINE DISORDERS.

Sumatriptan Manufacturers

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

Sumatriptan Suppliers

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

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

Sumatriptan USDMF

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

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

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

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

Sumatriptan KDMF

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

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

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

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

Sumatriptan CEP

A Sumatriptan CEP of the European Pharmacopoeia monograph is often referred to as a Sumatriptan Certificate of Suitability (COS). The purpose of a Sumatriptan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sumatriptan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sumatriptan to their clients by showing that a Sumatriptan CEP has been issued for it. The manufacturer submits a Sumatriptan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sumatriptan CEP holder for the record. Additionally, the data presented in the Sumatriptan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sumatriptan DMF.

A Sumatriptan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sumatriptan 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 Sumatriptan suppliers with CEP (COS) on PharmaCompass.

Sumatriptan WC

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

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

Sumatriptan 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 Sumatriptan as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Sumatriptan GMP

Sumatriptan 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 Sumatriptan 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 Sumatriptan GMP manufacturer or Sumatriptan GMP API supplier for your needs.

Sumatriptan CoA

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

Sumatriptan CoA mostly includes findings from lab analyses of a specific batch. For each Sumatriptan 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.

Sumatriptan may be tested according to a variety of international standards, such as European Pharmacopoeia (Sumatriptan EP), Sumatriptan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sumatriptan 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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