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PharmaCompass offers a list of Boric Acid 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 Boric Acid manufacturer or Boric Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Boric Acid manufacturer or Boric Acid supplier.
PharmaCompass also assists you with knowing the Boric Acid API Price utilized in the formulation of products. Boric Acid API Price is not always fixed or binding as the Boric Acid Price is obtained through a variety of data sources. The Boric Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Boric Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Boric Acid, including repackagers and relabelers. The FDA regulates Boric Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Boric Acid 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 Boric Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Boric Acid supplier is an individual or a company that provides Boric Acid active pharmaceutical ingredient (API) or Boric Acid finished formulations upon request. The Boric Acid suppliers may include Boric Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Boric Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Boric Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Boric Acid active pharmaceutical ingredient (API) in detail. Different forms of Boric Acid DMFs exist exist since differing nations have different regulations, such as Boric Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Boric Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Boric Acid USDMF includes data on Boric Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Boric Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Boric Acid 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 Boric Acid Drug Master File in Japan (Boric Acid JDMF) empowers Boric Acid 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 Boric Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Boric Acid 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 Boric Acid suppliers with JDMF on PharmaCompass.
A Boric Acid CEP of the European Pharmacopoeia monograph is often referred to as a Boric Acid Certificate of Suitability (COS). The purpose of a Boric Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Boric Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Boric Acid to their clients by showing that a Boric Acid CEP has been issued for it. The manufacturer submits a Boric Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Boric Acid CEP holder for the record. Additionally, the data presented in the Boric Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Boric Acid DMF.
A Boric Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Boric Acid 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 Boric Acid suppliers with CEP (COS) on PharmaCompass.
A Boric Acid written confirmation (Boric Acid WC) is an official document issued by a regulatory agency to a Boric Acid manufacturer, verifying that the manufacturing facility of a Boric Acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Boric Acid APIs or Boric Acid finished pharmaceutical products to another nation, regulatory agencies frequently require a Boric Acid WC (written confirmation) as part of the regulatory process.
click here to find a list of Boric Acid 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 Boric Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Boric Acid 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 Boric Acid 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 Boric Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Boric Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Boric Acid suppliers with NDC on PharmaCompass.
Boric Acid 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 Boric Acid 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 Boric Acid GMP manufacturer or Boric Acid GMP API supplier for your needs.
A Boric Acid CoA (Certificate of Analysis) is a formal document that attests to Boric Acid's compliance with Boric Acid specifications and serves as a tool for batch-level quality control.
Boric Acid CoA mostly includes findings from lab analyses of a specific batch. For each Boric Acid 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.
Boric Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Boric Acid EP), Boric Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Boric Acid USP).
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