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API SUPPLIERS
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USDMF
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DOSAGE - CAPSULE;ORAL - 750MG
USFDA APPLICATION NUMBER - 20610
DOSAGE - TABLET;ORAL - 1.1GM **Federal Regist...DOSAGE - TABLET;ORAL - 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22205
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ABOUT THIS PAGE
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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 Balzide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Balzide, including repackagers and relabelers. The FDA regulates Balzide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Balzide 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 Balzide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Balzide supplier is an individual or a company that provides Balzide active pharmaceutical ingredient (API) or Balzide finished formulations upon request. The Balzide suppliers may include Balzide API manufacturers, exporters, distributors and traders.
click here to find a list of Balzide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Balzide DMF (Drug Master File) is a document detailing the whole manufacturing process of Balzide active pharmaceutical ingredient (API) in detail. Different forms of Balzide DMFs exist exist since differing nations have different regulations, such as Balzide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Balzide DMF submitted to regulatory agencies in the US is known as a USDMF. Balzide USDMF includes data on Balzide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Balzide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Balzide 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 Balzide Drug Master File in Korea (Balzide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Balzide. The MFDS reviews the Balzide KDMF as part of the drug registration process and uses the information provided in the Balzide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Balzide 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 Balzide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Balzide suppliers with KDMF on PharmaCompass.
A Balzide written confirmation (Balzide WC) is an official document issued by a regulatory agency to a Balzide manufacturer, verifying that the manufacturing facility of a Balzide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Balzide APIs or Balzide finished pharmaceutical products to another nation, regulatory agencies frequently require a Balzide WC (written confirmation) as part of the regulatory process.
click here to find a list of Balzide 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 Balzide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Balzide 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 Balzide 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 Balzide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Balzide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Balzide suppliers with NDC on PharmaCompass.
Balzide 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 Balzide 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 Balzide GMP manufacturer or Balzide GMP API supplier for your needs.
A Balzide CoA (Certificate of Analysis) is a formal document that attests to Balzide's compliance with Balzide specifications and serves as a tool for batch-level quality control.
Balzide CoA mostly includes findings from lab analyses of a specific batch. For each Balzide 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.
Balzide may be tested according to a variety of international standards, such as European Pharmacopoeia (Balzide EP), Balzide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Balzide USP).
