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PharmaCompass offers a list of Sulindac 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 Sulindac manufacturer or Sulindac supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sulindac manufacturer or Sulindac supplier.
PharmaCompass also assists you with knowing the Sulindac API Price utilized in the formulation of products. Sulindac API Price is not always fixed or binding as the Sulindac Price is obtained through a variety of data sources. The Sulindac Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Alphapharm Brand of Sulindac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alphapharm Brand of Sulindac, including repackagers and relabelers. The FDA regulates Alphapharm Brand of Sulindac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alphapharm Brand of 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 Alphapharm Brand of Sulindac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alphapharm Brand of Sulindac supplier is an individual or a company that provides Alphapharm Brand of Sulindac active pharmaceutical ingredient (API) or Alphapharm Brand of Sulindac finished formulations upon request. The Alphapharm Brand of Sulindac suppliers may include Alphapharm Brand of Sulindac API manufacturers, exporters, distributors and traders.
click here to find a list of Alphapharm Brand of Sulindac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alphapharm Brand of Sulindac DMF (Drug Master File) is a document detailing the whole manufacturing process of Alphapharm Brand of Sulindac active pharmaceutical ingredient (API) in detail. Different forms of Alphapharm Brand of Sulindac DMFs exist exist since differing nations have different regulations, such as Alphapharm Brand of Sulindac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alphapharm Brand of Sulindac DMF submitted to regulatory agencies in the US is known as a USDMF. Alphapharm Brand of Sulindac USDMF includes data on Alphapharm Brand of Sulindac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alphapharm Brand of Sulindac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alphapharm Brand 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 Alphapharm Brand of Sulindac Drug Master File in Japan (Alphapharm Brand of Sulindac JDMF) empowers Alphapharm Brand of 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 Alphapharm Brand of Sulindac JDMF during the approval evaluation for pharmaceutical products. At the time of Alphapharm Brand 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 Alphapharm Brand of Sulindac suppliers with JDMF on PharmaCompass.
A Alphapharm Brand of Sulindac written confirmation (Alphapharm Brand of Sulindac WC) is an official document issued by a regulatory agency to a Alphapharm Brand of Sulindac manufacturer, verifying that the manufacturing facility of a Alphapharm Brand of Sulindac active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Alphapharm Brand of Sulindac APIs or Alphapharm Brand of Sulindac finished pharmaceutical products to another nation, regulatory agencies frequently require a Alphapharm Brand of Sulindac WC (written confirmation) as part of the regulatory process.
click here to find a list of Alphapharm Brand 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 Alphapharm Brand of Sulindac as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alphapharm Brand of 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 Alphapharm Brand of 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 Alphapharm Brand of Sulindac and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alphapharm Brand of Sulindac NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alphapharm Brand of Sulindac suppliers with NDC on PharmaCompass.
Alphapharm Brand of 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 Alphapharm Brand 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 Alphapharm Brand of Sulindac GMP manufacturer or Alphapharm Brand of Sulindac GMP API supplier for your needs.
A Alphapharm Brand of Sulindac CoA (Certificate of Analysis) is a formal document that attests to Alphapharm Brand of Sulindac's compliance with Alphapharm Brand of Sulindac specifications and serves as a tool for batch-level quality control.
Alphapharm Brand of Sulindac CoA mostly includes findings from lab analyses of a specific batch. For each Alphapharm Brand of 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.
Alphapharm Brand of Sulindac may be tested according to a variety of international standards, such as European Pharmacopoeia (Alphapharm Brand of Sulindac EP), Alphapharm Brand of Sulindac JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alphapharm Brand of Sulindac USP).