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ABOUT THIS PAGE
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PharmaCompass offers a list of Sulfasalazine 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 Sulfasalazine manufacturer or Sulfasalazine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sulfasalazine manufacturer or Sulfasalazine supplier.
PharmaCompass also assists you with knowing the Sulfasalazine API Price utilized in the formulation of products. Sulfasalazine API Price is not always fixed or binding as the Sulfasalazine Price is obtained through a variety of data sources. The Sulfasalazine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Colo Pleon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Colo Pleon, including repackagers and relabelers. The FDA regulates Colo Pleon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Colo Pleon 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 Colo Pleon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Colo Pleon supplier is an individual or a company that provides Colo Pleon active pharmaceutical ingredient (API) or Colo Pleon finished formulations upon request. The Colo Pleon suppliers may include Colo Pleon API manufacturers, exporters, distributors and traders.
click here to find a list of Colo Pleon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Colo Pleon DMF (Drug Master File) is a document detailing the whole manufacturing process of Colo Pleon active pharmaceutical ingredient (API) in detail. Different forms of Colo Pleon DMFs exist exist since differing nations have different regulations, such as Colo Pleon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Colo Pleon DMF submitted to regulatory agencies in the US is known as a USDMF. Colo Pleon USDMF includes data on Colo Pleon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Colo Pleon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Colo Pleon 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 Colo Pleon Drug Master File in Japan (Colo Pleon JDMF) empowers Colo Pleon 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 Colo Pleon JDMF during the approval evaluation for pharmaceutical products. At the time of Colo Pleon 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 Colo Pleon suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Colo Pleon Drug Master File in Korea (Colo Pleon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Colo Pleon. The MFDS reviews the Colo Pleon KDMF as part of the drug registration process and uses the information provided in the Colo Pleon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Colo Pleon KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Colo Pleon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Colo Pleon suppliers with KDMF on PharmaCompass.
A Colo Pleon CEP of the European Pharmacopoeia monograph is often referred to as a Colo Pleon Certificate of Suitability (COS). The purpose of a Colo Pleon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Colo Pleon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Colo Pleon to their clients by showing that a Colo Pleon CEP has been issued for it. The manufacturer submits a Colo Pleon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Colo Pleon CEP holder for the record. Additionally, the data presented in the Colo Pleon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Colo Pleon DMF.
A Colo Pleon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Colo Pleon CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Colo Pleon suppliers with CEP (COS) on PharmaCompass.
A Colo Pleon written confirmation (Colo Pleon WC) is an official document issued by a regulatory agency to a Colo Pleon manufacturer, verifying that the manufacturing facility of a Colo Pleon active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Colo Pleon APIs or Colo Pleon finished pharmaceutical products to another nation, regulatory agencies frequently require a Colo Pleon WC (written confirmation) as part of the regulatory process.
click here to find a list of Colo Pleon 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 Colo Pleon as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Colo Pleon 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 Colo Pleon 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 Colo Pleon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Colo Pleon NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Colo Pleon suppliers with NDC on PharmaCompass.
Colo Pleon 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 Colo Pleon 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 Colo Pleon GMP manufacturer or Colo Pleon GMP API supplier for your needs.
A Colo Pleon CoA (Certificate of Analysis) is a formal document that attests to Colo Pleon's compliance with Colo Pleon specifications and serves as a tool for batch-level quality control.
Colo Pleon CoA mostly includes findings from lab analyses of a specific batch. For each Colo Pleon 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.
Colo Pleon may be tested according to a variety of international standards, such as European Pharmacopoeia (Colo Pleon EP), Colo Pleon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Colo Pleon USP).
