Synopsis
0
JDMF
0
KDMF
0
VMF
0
FDF
0
Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Click Us!
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35615
Submission : 2021-02-04
Status :
Type : II
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] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
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]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - PATCH;TOPICAL - 70MG;70MG
USFDA APPLICATION NUMBER - 21623
DOSAGE - CREAM;TOPICAL - 7%;7%
USFDA APPLICATION NUMBER - 21717
Related Excipient Companies
Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
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]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
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]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lubrizol Life Science Health
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]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shandong Focus Biotechnology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Topical
Coating Systems & Additives
Solubilizers
Parenteral
Film Formers & Plasticizers
Thickeners and Stabilizers
Surfactant & Foaming Agents
Emulsifying Agents
Controlled & Modified Release
Lubricants & Glidants
Granulation
Co-Processed Excipients
Fillers, Diluents & Binders
Direct Compression
Taste Masking
Disintegrants & Superdisintegrants
API Stability Enhancers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Tetracaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tetracaine, including repackagers and relabelers. The FDA regulates Tetracaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tetracaine 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 Tetracaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tetracaine supplier is an individual or a company that provides Tetracaine active pharmaceutical ingredient (API) or Tetracaine finished formulations upon request. The Tetracaine suppliers may include Tetracaine API manufacturers, exporters, distributors and traders.
click here to find a list of Tetracaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tetracaine DMF (Drug Master File) is a document detailing the whole manufacturing process of Tetracaine active pharmaceutical ingredient (API) in detail. Different forms of Tetracaine DMFs exist exist since differing nations have different regulations, such as Tetracaine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tetracaine DMF submitted to regulatory agencies in the US is known as a USDMF. Tetracaine USDMF includes data on Tetracaine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tetracaine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tetracaine suppliers with USDMF on PharmaCompass.
A Tetracaine CEP of the European Pharmacopoeia monograph is often referred to as a Tetracaine Certificate of Suitability (COS). The purpose of a Tetracaine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tetracaine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tetracaine to their clients by showing that a Tetracaine CEP has been issued for it. The manufacturer submits a Tetracaine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tetracaine CEP holder for the record. Additionally, the data presented in the Tetracaine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tetracaine DMF.
A Tetracaine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tetracaine 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 Tetracaine suppliers with CEP (COS) on PharmaCompass.
A Tetracaine written confirmation (Tetracaine WC) is an official document issued by a regulatory agency to a Tetracaine manufacturer, verifying that the manufacturing facility of a Tetracaine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tetracaine APIs or Tetracaine finished pharmaceutical products to another nation, regulatory agencies frequently require a Tetracaine WC (written confirmation) as part of the regulatory process.
click here to find a list of Tetracaine 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 Tetracaine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tetracaine 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 Tetracaine 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 Tetracaine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tetracaine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tetracaine suppliers with NDC on PharmaCompass.
Tetracaine 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 Tetracaine 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 Tetracaine GMP manufacturer or Tetracaine GMP API supplier for your needs.
A Tetracaine CoA (Certificate of Analysis) is a formal document that attests to Tetracaine's compliance with Tetracaine specifications and serves as a tool for batch-level quality control.
Tetracaine CoA mostly includes findings from lab analyses of a specific batch. For each Tetracaine 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.
Tetracaine may be tested according to a variety of international standards, such as European Pharmacopoeia (Tetracaine EP), Tetracaine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tetracaine USP).
LOOKING FOR A SUPPLIER?
