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