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API SUPPLIERS
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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
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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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 SNAC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SNAC, including repackagers and relabelers. The FDA regulates SNAC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SNAC 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 SNAC manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SNAC supplier is an individual or a company that provides SNAC active pharmaceutical ingredient (API) or SNAC finished formulations upon request. The SNAC suppliers may include SNAC API manufacturers, exporters, distributors and traders.
click here to find a list of SNAC suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SNAC DMF (Drug Master File) is a document detailing the whole manufacturing process of SNAC active pharmaceutical ingredient (API) in detail. Different forms of SNAC DMFs exist exist since differing nations have different regulations, such as SNAC USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SNAC DMF submitted to regulatory agencies in the US is known as a USDMF. SNAC USDMF includes data on SNAC's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SNAC USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SNAC 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 SNAC as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SNAC 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 SNAC 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 SNAC and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SNAC NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SNAC suppliers with NDC on PharmaCompass.
SNAC 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 SNAC 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 SNAC GMP manufacturer or SNAC GMP API supplier for your needs.
A SNAC CoA (Certificate of Analysis) is a formal document that attests to SNAC's compliance with SNAC specifications and serves as a tool for batch-level quality control.
SNAC CoA mostly includes findings from lab analyses of a specific batch. For each SNAC 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.
SNAC may be tested according to a variety of international standards, such as European Pharmacopoeia (SNAC EP), SNAC JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SNAC USP).
Comment (3)
