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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.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Together we can improve the quality of life
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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.
Date of Issue : 2023-11-06
Valid Till : 2026-11-05
Written Confirmation Number : SD230069
Address of the Firm : Economic Development Zone, Pingyuan County, Dezhou City, Shandong, PR China
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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...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
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...
Together we can improve the quality of life
About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with over 26 years of expertise in human and veterinary pharmaceuticals. Operating in 40+ countries, we own two st...
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PharmaCompass offers a list of Tetracaine 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 Tetracaine Hydrochloride manufacturer or Tetracaine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tetracaine Hydrochloride manufacturer or Tetracaine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Tetracaine Hydrochloride API Price utilized in the formulation of products. Tetracaine Hydrochloride API Price is not always fixed or binding as the Tetracaine Hydrochloride Price is obtained through a variety of data sources. The Tetracaine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A TETRACAINE HCL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TETRACAINE HCL, including repackagers and relabelers. The FDA regulates TETRACAINE HCL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TETRACAINE HCL 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 HCL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A TETRACAINE HCL supplier is an individual or a company that provides TETRACAINE HCL active pharmaceutical ingredient (API) or TETRACAINE HCL finished formulations upon request. The TETRACAINE HCL suppliers may include TETRACAINE HCL API manufacturers, exporters, distributors and traders.
click here to find a list of TETRACAINE HCL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TETRACAINE HCL DMF (Drug Master File) is a document detailing the whole manufacturing process of TETRACAINE HCL active pharmaceutical ingredient (API) in detail. Different forms of TETRACAINE HCL DMFs exist exist since differing nations have different regulations, such as TETRACAINE HCL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TETRACAINE HCL DMF submitted to regulatory agencies in the US is known as a USDMF. TETRACAINE HCL USDMF includes data on TETRACAINE HCL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TETRACAINE HCL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TETRACAINE HCL 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 TETRACAINE HCL Drug Master File in Japan (TETRACAINE HCL JDMF) empowers TETRACAINE HCL 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 TETRACAINE HCL JDMF during the approval evaluation for pharmaceutical products. At the time of TETRACAINE HCL 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 TETRACAINE HCL suppliers with JDMF on PharmaCompass.
A TETRACAINE HCL CEP of the European Pharmacopoeia monograph is often referred to as a TETRACAINE HCL Certificate of Suitability (COS). The purpose of a TETRACAINE HCL CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of TETRACAINE HCL EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of TETRACAINE HCL to their clients by showing that a TETRACAINE HCL CEP has been issued for it. The manufacturer submits a TETRACAINE HCL CEP (COS) as part of the market authorization procedure, and it takes on the role of a TETRACAINE HCL CEP holder for the record. Additionally, the data presented in the TETRACAINE HCL CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the TETRACAINE HCL DMF.
A TETRACAINE HCL CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. TETRACAINE HCL 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 HCL suppliers with CEP (COS) on PharmaCompass.
A TETRACAINE HCL written confirmation (TETRACAINE HCL WC) is an official document issued by a regulatory agency to a TETRACAINE HCL manufacturer, verifying that the manufacturing facility of a TETRACAINE HCL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TETRACAINE HCL APIs or TETRACAINE HCL finished pharmaceutical products to another nation, regulatory agencies frequently require a TETRACAINE HCL WC (written confirmation) as part of the regulatory process.
click here to find a list of TETRACAINE HCL 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 HCL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for TETRACAINE HCL 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 HCL 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 HCL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TETRACAINE HCL NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of TETRACAINE HCL suppliers with NDC on PharmaCompass.
TETRACAINE HCL 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 HCL 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 HCL GMP manufacturer or TETRACAINE HCL GMP API supplier for your needs.
A TETRACAINE HCL CoA (Certificate of Analysis) is a formal document that attests to TETRACAINE HCL's compliance with TETRACAINE HCL specifications and serves as a tool for batch-level quality control.
TETRACAINE HCL CoA mostly includes findings from lab analyses of a specific batch. For each TETRACAINE HCL 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 HCL may be tested according to a variety of international standards, such as European Pharmacopoeia (TETRACAINE HCL EP), TETRACAINE HCL JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TETRACAINE HCL USP).
