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JDMF
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KDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
FDF
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Data Compilation #PharmaFlow
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API SUPPLIERS
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
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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 Pharma - Market Expansion Leader in Pharmaceuticals.
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
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China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
About the Company : Apex Healthcare Limited, established in 2002, is a trusted manufacturer and exporter of APIs, bulk drugs, and formulations, based in Ankleshwar, India’s largest chemical industri...
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DOSAGE - PATCH;TOPICAL - 70MG;70MG
USFDA APPLICATION NUMBER - 21623
DOSAGE - CREAM;TOPICAL - 7%;7%
USFDA APPLICATION NUMBER - 21717
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Coating Systems & Additives
Solubilizers
Parenteral
Thickeners and Stabilizers
Surfactant & Foaming Agents
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Film Formers & Plasticizers
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ABOUT THIS PAGE
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PharmaCompass offers a list of Tetracaine 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 Tetracaine manufacturer or Tetracaine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tetracaine manufacturer or Tetracaine supplier.
PharmaCompass also assists you with knowing the Tetracaine API Price utilized in the formulation of products. Tetracaine API Price is not always fixed or binding as the Tetracaine Price is obtained through a variety of data sources. The Tetracaine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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).
