Synopsis
0
CEP/COS
0
JDMF
0
KDMF
0
VMF
0
FDF
0
Europe
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
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US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - POWDER;INTRAVENOUS - 0.005MG/VIAL
USFDA APPLICATION NUMBER - 17697
DOSAGE - POWDER;INTRAVENOUS - 0.005MG/VIAL
USFDA APPLICATION NUMBER - 210850
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Sincalide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sincalide, including repackagers and relabelers. The FDA regulates Sincalide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sincalide 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 Sincalide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sincalide supplier is an individual or a company that provides Sincalide active pharmaceutical ingredient (API) or Sincalide finished formulations upon request. The Sincalide suppliers may include Sincalide API manufacturers, exporters, distributors and traders.
click here to find a list of Sincalide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sincalide DMF (Drug Master File) is a document detailing the whole manufacturing process of Sincalide active pharmaceutical ingredient (API) in detail. Different forms of Sincalide DMFs exist exist since differing nations have different regulations, such as Sincalide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sincalide DMF submitted to regulatory agencies in the US is known as a USDMF. Sincalide USDMF includes data on Sincalide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sincalide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sincalide suppliers with USDMF on PharmaCompass.
A Sincalide written confirmation (Sincalide WC) is an official document issued by a regulatory agency to a Sincalide manufacturer, verifying that the manufacturing facility of a Sincalide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sincalide APIs or Sincalide finished pharmaceutical products to another nation, regulatory agencies frequently require a Sincalide WC (written confirmation) as part of the regulatory process.
click here to find a list of Sincalide 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 Sincalide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sincalide 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 Sincalide 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 Sincalide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sincalide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sincalide suppliers with NDC on PharmaCompass.
Sincalide 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 Sincalide 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 Sincalide GMP manufacturer or Sincalide GMP API supplier for your needs.
A Sincalide CoA (Certificate of Analysis) is a formal document that attests to Sincalide's compliance with Sincalide specifications and serves as a tool for batch-level quality control.
Sincalide CoA mostly includes findings from lab analyses of a specific batch. For each Sincalide 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.
Sincalide may be tested according to a variety of international standards, such as European Pharmacopoeia (Sincalide EP), Sincalide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sincalide USP).
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