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