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Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Proparacaine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Proparacaine hydrochloride, including repackagers and relabelers. The FDA regulates Proparacaine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Proparacaine 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 Proparacaine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Proparacaine hydrochloride supplier is an individual or a company that provides Proparacaine hydrochloride active pharmaceutical ingredient (API) or Proparacaine hydrochloride finished formulations upon request. The Proparacaine hydrochloride suppliers may include Proparacaine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Proparacaine hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Proparacaine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Proparacaine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Proparacaine hydrochloride DMFs exist exist since differing nations have different regulations, such as Proparacaine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Proparacaine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Proparacaine hydrochloride USDMF includes data on Proparacaine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Proparacaine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Proparacaine hydrochloride suppliers with USDMF on PharmaCompass.
A Proparacaine hydrochloride written confirmation (Proparacaine hydrochloride WC) is an official document issued by a regulatory agency to a Proparacaine hydrochloride manufacturer, verifying that the manufacturing facility of a Proparacaine hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Proparacaine hydrochloride APIs or Proparacaine hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Proparacaine hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Proparacaine hydrochloride 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 Proparacaine hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Proparacaine 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 Proparacaine 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 Proparacaine hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Proparacaine hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Proparacaine hydrochloride suppliers with NDC on PharmaCompass.
Proparacaine 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 Proparacaine 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 Proparacaine hydrochloride GMP manufacturer or Proparacaine hydrochloride GMP API supplier for your needs.
A Proparacaine hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Proparacaine hydrochloride's compliance with Proparacaine hydrochloride specifications and serves as a tool for batch-level quality control.
Proparacaine hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Proparacaine 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.
Proparacaine hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Proparacaine hydrochloride EP), Proparacaine hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Proparacaine hydrochloride USP).
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