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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Canada
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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DOSAGE - GEL;TOPICAL - 1%
USFDA APPLICATION NUMBER - 19356
DOSAGE - CREAM;TOPICAL - 1% **Federal Registe...DOSAGE - CREAM;TOPICAL - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19599
DOSAGE - CREAM;TOPICAL - 2%
USFDA APPLICATION NUMBER - 19599
DOSAGE - GEL;TOPICAL - 2%
USFDA APPLICATION NUMBER - 204286
Related Excipient Companies
Nanjing Well Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lubrizol Life Science Health
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
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Solubilizers
Emulsifying Agents
Thickeners and Stabilizers
Parenteral
Surfactant & Foaming Agents
Rheology Modifiers
Film Formers & Plasticizers
Direct Compression
Co-Processed Excipients
API Stability Enhancers
Controlled & Modified Release
Granulation
Lubricants & Glidants
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A NAFTIFINE HCL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NAFTIFINE HCL, including repackagers and relabelers. The FDA regulates NAFTIFINE HCL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NAFTIFINE 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 NAFTIFINE HCL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A NAFTIFINE HCL supplier is an individual or a company that provides NAFTIFINE HCL active pharmaceutical ingredient (API) or NAFTIFINE HCL finished formulations upon request. The NAFTIFINE HCL suppliers may include NAFTIFINE HCL API manufacturers, exporters, distributors and traders.
click here to find a list of NAFTIFINE HCL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A NAFTIFINE HCL DMF (Drug Master File) is a document detailing the whole manufacturing process of NAFTIFINE HCL active pharmaceutical ingredient (API) in detail. Different forms of NAFTIFINE HCL DMFs exist exist since differing nations have different regulations, such as NAFTIFINE HCL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A NAFTIFINE HCL DMF submitted to regulatory agencies in the US is known as a USDMF. NAFTIFINE HCL USDMF includes data on NAFTIFINE HCL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The NAFTIFINE HCL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of NAFTIFINE 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 NAFTIFINE HCL Drug Master File in Korea (NAFTIFINE HCL KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of NAFTIFINE HCL. The MFDS reviews the NAFTIFINE HCL KDMF as part of the drug registration process and uses the information provided in the NAFTIFINE HCL KDMF to evaluate the safety and efficacy of the drug.
After submitting a NAFTIFINE 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 NAFTIFINE HCL API can apply through the Korea Drug Master File (KDMF).
click here to find a list of NAFTIFINE HCL suppliers with KDMF on PharmaCompass.
A NAFTIFINE HCL written confirmation (NAFTIFINE HCL WC) is an official document issued by a regulatory agency to a NAFTIFINE HCL manufacturer, verifying that the manufacturing facility of a NAFTIFINE HCL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting NAFTIFINE HCL APIs or NAFTIFINE HCL finished pharmaceutical products to another nation, regulatory agencies frequently require a NAFTIFINE HCL WC (written confirmation) as part of the regulatory process.
click here to find a list of NAFTIFINE 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 NAFTIFINE HCL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for NAFTIFINE 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 NAFTIFINE 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 NAFTIFINE HCL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a NAFTIFINE HCL NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of NAFTIFINE HCL suppliers with NDC on PharmaCompass.
NAFTIFINE 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 NAFTIFINE 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 NAFTIFINE HCL GMP manufacturer or NAFTIFINE HCL GMP API supplier for your needs.
A NAFTIFINE HCL CoA (Certificate of Analysis) is a formal document that attests to NAFTIFINE HCL's compliance with NAFTIFINE HCL specifications and serves as a tool for batch-level quality control.
NAFTIFINE HCL CoA mostly includes findings from lab analyses of a specific batch. For each NAFTIFINE 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.
NAFTIFINE HCL may be tested according to a variety of international standards, such as European Pharmacopoeia (NAFTIFINE HCL EP), NAFTIFINE HCL JP (Japanese Pharmacopeia) and the US Pharmacopoeia (NAFTIFINE HCL USP).
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