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SPI Pharma
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Sulindac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulindac, including repackagers and relabelers. The FDA regulates Sulindac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulindac 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 Sulindac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulindac supplier is an individual or a company that provides Sulindac active pharmaceutical ingredient (API) or Sulindac finished formulations upon request. The Sulindac suppliers may include Sulindac API manufacturers, exporters, distributors and traders.
click here to find a list of Sulindac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulindac DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulindac active pharmaceutical ingredient (API) in detail. Different forms of Sulindac DMFs exist exist since differing nations have different regulations, such as Sulindac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sulindac DMF submitted to regulatory agencies in the US is known as a USDMF. Sulindac USDMF includes data on Sulindac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulindac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sulindac suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Sulindac Drug Master File in Japan (Sulindac JDMF) empowers Sulindac API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Sulindac JDMF during the approval evaluation for pharmaceutical products. At the time of Sulindac JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Sulindac suppliers with JDMF on PharmaCompass.
A Sulindac written confirmation (Sulindac WC) is an official document issued by a regulatory agency to a Sulindac manufacturer, verifying that the manufacturing facility of a Sulindac active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sulindac APIs or Sulindac finished pharmaceutical products to another nation, regulatory agencies frequently require a Sulindac WC (written confirmation) as part of the regulatory process.
click here to find a list of Sulindac 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 Sulindac as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sulindac 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 Sulindac 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 Sulindac and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sulindac NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sulindac suppliers with NDC on PharmaCompass.
Sulindac 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 Sulindac 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 Sulindac GMP manufacturer or Sulindac GMP API supplier for your needs.
A Sulindac CoA (Certificate of Analysis) is a formal document that attests to Sulindac's compliance with Sulindac specifications and serves as a tool for batch-level quality control.
Sulindac CoA mostly includes findings from lab analyses of a specific batch. For each Sulindac 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.
Sulindac may be tested according to a variety of international standards, such as European Pharmacopoeia (Sulindac EP), Sulindac JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sulindac USP).
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