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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.
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 Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Mesochem is focused on incessant innovation along with the R&D of new APIs.
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USDMF
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40707
Submission : 2024-11-26
Status :
Type : IV
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
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29 Sep 2021
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ABOUT THIS PAGE
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.
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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