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ABOUT THIS PAGE
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PharmaCompass offers a list of Sulodexide 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 Sulodexide manufacturer or Sulodexide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sulodexide manufacturer or Sulodexide supplier.
PharmaCompass also assists you with knowing the Sulodexide API Price utilized in the formulation of products. Sulodexide API Price is not always fixed or binding as the Sulodexide Price is obtained through a variety of data sources. The Sulodexide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sulodexide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulodexide, including repackagers and relabelers. The FDA regulates Sulodexide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulodexide 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 Sulodexide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulodexide supplier is an individual or a company that provides Sulodexide active pharmaceutical ingredient (API) or Sulodexide finished formulations upon request. The Sulodexide suppliers may include Sulodexide API manufacturers, exporters, distributors and traders.
click here to find a list of Sulodexide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulodexide DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulodexide active pharmaceutical ingredient (API) in detail. Different forms of Sulodexide DMFs exist exist since differing nations have different regulations, such as Sulodexide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sulodexide DMF submitted to regulatory agencies in the US is known as a USDMF. Sulodexide USDMF includes data on Sulodexide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulodexide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sulodexide 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 Sulodexide Drug Master File in Korea (Sulodexide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sulodexide. The MFDS reviews the Sulodexide KDMF as part of the drug registration process and uses the information provided in the Sulodexide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sulodexide 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 Sulodexide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sulodexide suppliers with KDMF on PharmaCompass.
Sulodexide 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 Sulodexide 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 Sulodexide GMP manufacturer or Sulodexide GMP API supplier for your needs.
A Sulodexide CoA (Certificate of Analysis) is a formal document that attests to Sulodexide's compliance with Sulodexide specifications and serves as a tool for batch-level quality control.
Sulodexide CoA mostly includes findings from lab analyses of a specific batch. For each Sulodexide 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.
Sulodexide may be tested according to a variety of international standards, such as European Pharmacopoeia (Sulodexide EP), Sulodexide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sulodexide USP).
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