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