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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
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EUROAPI
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Tablet
Grade : Oral
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Parenteral
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PharmaCompass offers a list of Sodium Thiosulfate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sodium Thiosulfate manufacturer or Sodium Thiosulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Thiosulfate manufacturer or Sodium Thiosulfate supplier.
A Sodium Thiosulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Thiosulfate, including repackagers and relabelers. The FDA regulates Sodium Thiosulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Thiosulfate 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 Sodium Thiosulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sodium Thiosulfate supplier is an individual or a company that provides Sodium Thiosulfate active pharmaceutical ingredient (API) or Sodium Thiosulfate finished formulations upon request. The Sodium Thiosulfate suppliers may include Sodium Thiosulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Thiosulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sodium Thiosulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Thiosulfate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Thiosulfate DMFs exist exist since differing nations have different regulations, such as Sodium Thiosulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Thiosulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Thiosulfate USDMF includes data on Sodium Thiosulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Thiosulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Thiosulfate suppliers with USDMF on PharmaCompass.
A Sodium Thiosulfate CEP of the European Pharmacopoeia monograph is often referred to as a Sodium Thiosulfate Certificate of Suitability (COS). The purpose of a Sodium Thiosulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium Thiosulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium Thiosulfate to their clients by showing that a Sodium Thiosulfate CEP has been issued for it. The manufacturer submits a Sodium Thiosulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium Thiosulfate CEP holder for the record. Additionally, the data presented in the Sodium Thiosulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium Thiosulfate DMF.
A Sodium Thiosulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium Thiosulfate 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 Sodium Thiosulfate suppliers with CEP (COS) 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 Sodium Thiosulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium Thiosulfate 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 Sodium Thiosulfate 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 Sodium Thiosulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium Thiosulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium Thiosulfate suppliers with NDC on PharmaCompass.
Sodium Thiosulfate 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 Sodium Thiosulfate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sodium Thiosulfate GMP manufacturer or Sodium Thiosulfate GMP API supplier for your needs.
A Sodium Thiosulfate CoA (Certificate of Analysis) is a formal document that attests to Sodium Thiosulfate's compliance with Sodium Thiosulfate specifications and serves as a tool for batch-level quality control.
Sodium Thiosulfate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Thiosulfate 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.
Sodium Thiosulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Thiosulfate EP), Sodium Thiosulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Thiosulfate USP).
