Synopsis
0
EU WC
0
KDMF
0
VMF
0
Canada
0
Australia
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.4%;0.2...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.4%;0.25%
USFDA APPLICATION NUMBER - 208582
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.4%;0.3...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.4%;0.3%
USFDA APPLICATION NUMBER - 211039
Related Excipient Companies
Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Solubilizers
Granulation
Direct Compression
Parenteral
Controlled & Modified Release
Co-Processed Excipients
Coating Systems & Additives
Disintegrants & Superdisintegrants
Thickeners and Stabilizers
Topical
Film Formers & Plasticizers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Oxybuprocaine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxybuprocaine Hydrochloride, including repackagers and relabelers. The FDA regulates Oxybuprocaine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxybuprocaine Hydrochloride 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 Oxybuprocaine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxybuprocaine Hydrochloride supplier is an individual or a company that provides Oxybuprocaine Hydrochloride active pharmaceutical ingredient (API) or Oxybuprocaine Hydrochloride finished formulations upon request. The Oxybuprocaine Hydrochloride suppliers may include Oxybuprocaine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Oxybuprocaine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxybuprocaine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxybuprocaine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Oxybuprocaine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Oxybuprocaine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxybuprocaine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Oxybuprocaine Hydrochloride USDMF includes data on Oxybuprocaine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxybuprocaine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxybuprocaine Hydrochloride 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 Oxybuprocaine Hydrochloride Drug Master File in Japan (Oxybuprocaine Hydrochloride JDMF) empowers Oxybuprocaine Hydrochloride 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 Oxybuprocaine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Oxybuprocaine Hydrochloride 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 Oxybuprocaine Hydrochloride suppliers with JDMF on PharmaCompass.
A Oxybuprocaine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Oxybuprocaine Hydrochloride Certificate of Suitability (COS). The purpose of a Oxybuprocaine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxybuprocaine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxybuprocaine Hydrochloride to their clients by showing that a Oxybuprocaine Hydrochloride CEP has been issued for it. The manufacturer submits a Oxybuprocaine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxybuprocaine Hydrochloride CEP holder for the record. Additionally, the data presented in the Oxybuprocaine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxybuprocaine Hydrochloride DMF.
A Oxybuprocaine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxybuprocaine Hydrochloride 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 Oxybuprocaine Hydrochloride 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 Oxybuprocaine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oxybuprocaine Hydrochloride 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 Oxybuprocaine Hydrochloride 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 Oxybuprocaine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxybuprocaine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oxybuprocaine Hydrochloride suppliers with NDC on PharmaCompass.
Oxybuprocaine Hydrochloride 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 Oxybuprocaine Hydrochloride 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 Oxybuprocaine Hydrochloride GMP manufacturer or Oxybuprocaine Hydrochloride GMP API supplier for your needs.
A Oxybuprocaine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Oxybuprocaine Hydrochloride's compliance with Oxybuprocaine Hydrochloride specifications and serves as a tool for batch-level quality control.
Oxybuprocaine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Oxybuprocaine Hydrochloride 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.
Oxybuprocaine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxybuprocaine Hydrochloride EP), Oxybuprocaine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxybuprocaine Hydrochloride USP).
LOOKING FOR A SUPPLIER?
