Synopsis
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CEP/COS
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JDMF
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VMF
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FDF
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Europe
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Australia
DRUG PRODUCT COMPOSITIONS
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US Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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News #PharmaBuzz
US Medicaid
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Annual Reports
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Finished Drug Prices
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API SUPPLIERS
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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 ...
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...
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API Imports and Exports
INTERMEDIATE SUPPLIERS
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Topical
Solubilizers
Coating Systems & Additives
Thickeners and Stabilizers
Controlled & Modified Release
Parenteral
Film Formers & Plasticizers
Fillers, Diluents & Binders
Surfactant & Foaming Agents
Emulsifying Agents
Granulation
Taste Masking
Direct Compression
Rheology Modifiers
Lubricants & Glidants
Co-Processed Excipients
API Stability Enhancers
Chewable & Orodispersible Aids
Empty Capsules
Disintegrants & Superdisintegrants
Vegetarian Capsules
Coloring Agents
Soft Gelatin
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Pramoxine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pramoxine HCl, including repackagers and relabelers. The FDA regulates Pramoxine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pramoxine 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 Pramoxine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pramoxine HCl supplier is an individual or a company that provides Pramoxine HCl active pharmaceutical ingredient (API) or Pramoxine HCl finished formulations upon request. The Pramoxine HCl suppliers may include Pramoxine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Pramoxine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pramoxine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Pramoxine HCl active pharmaceutical ingredient (API) in detail. Different forms of Pramoxine HCl DMFs exist exist since differing nations have different regulations, such as Pramoxine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pramoxine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Pramoxine HCl USDMF includes data on Pramoxine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pramoxine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pramoxine HCl suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Pramoxine HCl Drug Master File in Korea (Pramoxine HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pramoxine HCl. The MFDS reviews the Pramoxine HCl KDMF as part of the drug registration process and uses the information provided in the Pramoxine HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pramoxine HCl KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Pramoxine HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pramoxine HCl suppliers with KDMF on PharmaCompass.
A Pramoxine HCl written confirmation (Pramoxine HCl WC) is an official document issued by a regulatory agency to a Pramoxine HCl manufacturer, verifying that the manufacturing facility of a Pramoxine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pramoxine HCl APIs or Pramoxine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Pramoxine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Pramoxine 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 Pramoxine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pramoxine 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 Pramoxine 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 Pramoxine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pramoxine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pramoxine HCl suppliers with NDC on PharmaCompass.
Pramoxine 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 Pramoxine 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 Pramoxine HCl GMP manufacturer or Pramoxine HCl GMP API supplier for your needs.
A Pramoxine HCl CoA (Certificate of Analysis) is a formal document that attests to Pramoxine HCl's compliance with Pramoxine HCl specifications and serves as a tool for batch-level quality control.
Pramoxine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Pramoxine 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.
Pramoxine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Pramoxine HCl EP), Pramoxine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pramoxine HCl USP).
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