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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40217
Submission : 2024-07-22
Status :
Type : IV
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38202
Submission : 2023-03-31
Status :
Type : IV
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...
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&...
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...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Thro...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Salcaprozate Sodium 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 Salcaprozate Sodium manufacturer or Salcaprozate Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Salcaprozate Sodium manufacturer or Salcaprozate Sodium supplier.
PharmaCompass also assists you with knowing the Salcaprozate Sodium API Price utilized in the formulation of products. Salcaprozate Sodium API Price is not always fixed or binding as the Salcaprozate Sodium Price is obtained through a variety of data sources. The Salcaprozate Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Salcaprozate (sodium) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Salcaprozate (sodium), including repackagers and relabelers. The FDA regulates Salcaprozate (sodium) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Salcaprozate (sodium) 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 Salcaprozate (sodium) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Salcaprozate (sodium) supplier is an individual or a company that provides Salcaprozate (sodium) active pharmaceutical ingredient (API) or Salcaprozate (sodium) finished formulations upon request. The Salcaprozate (sodium) suppliers may include Salcaprozate (sodium) API manufacturers, exporters, distributors and traders.
click here to find a list of Salcaprozate (sodium) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Salcaprozate (sodium) DMF (Drug Master File) is a document detailing the whole manufacturing process of Salcaprozate (sodium) active pharmaceutical ingredient (API) in detail. Different forms of Salcaprozate (sodium) DMFs exist exist since differing nations have different regulations, such as Salcaprozate (sodium) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Salcaprozate (sodium) DMF submitted to regulatory agencies in the US is known as a USDMF. Salcaprozate (sodium) USDMF includes data on Salcaprozate (sodium)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Salcaprozate (sodium) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Salcaprozate (sodium) suppliers with USDMF on PharmaCompass.
A Salcaprozate (sodium) written confirmation (Salcaprozate (sodium) WC) is an official document issued by a regulatory agency to a Salcaprozate (sodium) manufacturer, verifying that the manufacturing facility of a Salcaprozate (sodium) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Salcaprozate (sodium) APIs or Salcaprozate (sodium) finished pharmaceutical products to another nation, regulatory agencies frequently require a Salcaprozate (sodium) WC (written confirmation) as part of the regulatory process.
click here to find a list of Salcaprozate (sodium) 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 Salcaprozate (sodium) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Salcaprozate (sodium) 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 Salcaprozate (sodium) 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 Salcaprozate (sodium) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Salcaprozate (sodium) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Salcaprozate (sodium) suppliers with NDC on PharmaCompass.
Salcaprozate (sodium) 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 Salcaprozate (sodium) 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 Salcaprozate (sodium) GMP manufacturer or Salcaprozate (sodium) GMP API supplier for your needs.
A Salcaprozate (sodium) CoA (Certificate of Analysis) is a formal document that attests to Salcaprozate (sodium)'s compliance with Salcaprozate (sodium) specifications and serves as a tool for batch-level quality control.
Salcaprozate (sodium) CoA mostly includes findings from lab analyses of a specific batch. For each Salcaprozate (sodium) 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.
Salcaprozate (sodium) may be tested according to a variety of international standards, such as European Pharmacopoeia (Salcaprozate (sodium) EP), Salcaprozate (sodium) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Salcaprozate (sodium) USP).
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