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API SUPPLIERS
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USDMF
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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...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Granisetron 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 Granisetron manufacturer or Granisetron supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Granisetron manufacturer or Granisetron supplier.
PharmaCompass also assists you with knowing the Granisetron API Price utilized in the formulation of products. Granisetron API Price is not always fixed or binding as the Granisetron Price is obtained through a variety of data sources. The Granisetron Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A SUSTOL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SUSTOL, including repackagers and relabelers. The FDA regulates SUSTOL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SUSTOL 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 SUSTOL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SUSTOL supplier is an individual or a company that provides SUSTOL active pharmaceutical ingredient (API) or SUSTOL finished formulations upon request. The SUSTOL suppliers may include SUSTOL API manufacturers, exporters, distributors and traders.
click here to find a list of SUSTOL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SUSTOL DMF (Drug Master File) is a document detailing the whole manufacturing process of SUSTOL active pharmaceutical ingredient (API) in detail. Different forms of SUSTOL DMFs exist exist since differing nations have different regulations, such as SUSTOL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SUSTOL DMF submitted to regulatory agencies in the US is known as a USDMF. SUSTOL USDMF includes data on SUSTOL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SUSTOL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SUSTOL suppliers with USDMF 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 SUSTOL Drug Master File in Korea (SUSTOL KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SUSTOL. The MFDS reviews the SUSTOL KDMF as part of the drug registration process and uses the information provided in the SUSTOL KDMF to evaluate the safety and efficacy of the drug.
After submitting a SUSTOL 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 SUSTOL API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SUSTOL suppliers with KDMF on PharmaCompass.
A SUSTOL written confirmation (SUSTOL WC) is an official document issued by a regulatory agency to a SUSTOL manufacturer, verifying that the manufacturing facility of a SUSTOL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SUSTOL APIs or SUSTOL finished pharmaceutical products to another nation, regulatory agencies frequently require a SUSTOL WC (written confirmation) as part of the regulatory process.
click here to find a list of SUSTOL 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 SUSTOL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SUSTOL 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 SUSTOL 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 SUSTOL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SUSTOL NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SUSTOL suppliers with NDC on PharmaCompass.
SUSTOL 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 SUSTOL 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 SUSTOL GMP manufacturer or SUSTOL GMP API supplier for your needs.
A SUSTOL CoA (Certificate of Analysis) is a formal document that attests to SUSTOL's compliance with SUSTOL specifications and serves as a tool for batch-level quality control.
SUSTOL CoA mostly includes findings from lab analyses of a specific batch. For each SUSTOL 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.
SUSTOL may be tested according to a variety of international standards, such as European Pharmacopoeia (SUSTOL EP), SUSTOL JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SUSTOL USP).
