Synopsis
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CEP/COS
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KDMF
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VMF
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Australia
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
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25528
Submission : 2014-12-17
Status :
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28205
Submission : 2015-12-29
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-22
Pay. Date : 2014-07-11
DMF Number : 28432
Submission : 2014-07-22
Status :
Type : II
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
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, ...
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 ...
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
About the Company : Deccan Nutraceuticals Pvt. Ltd. (DNPL) is a group company of Alkaloids Corporation (India), was founded in 2001 and operates from a 22,000 sq. m. facility in Pune (India). Their co...
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.3%
USFDA APPLICATION NUMBER - 203491
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.1%
USFDA APPLICATION NUMBER - 21862
Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Chewable & Orodispersible Aids
Taste Masking
Direct Compression
Thickeners and Stabilizers
Solubilizers
Parenteral
Disintegrants & Superdisintegrants
Co-Processed Excipients
Topical
Rheology Modifiers
Granulation
Film Formers & Plasticizers
Coating Systems & Additives
API Stability Enhancers
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Cream / Lotion / Ointment, Gel, Orodispersible Tablet, Tablet
Grade : Topical, Oral
Application : API Stability Enhancers, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Guar gum is used in oral solid dosage forms as a binder and disintegrant. It is also used as a suspending and thickening agent in topical products.
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Nepafenac 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 Nepafenac manufacturer or Nepafenac supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nepafenac manufacturer or Nepafenac supplier.
PharmaCompass also assists you with knowing the Nepafenac API Price utilized in the formulation of products. Nepafenac API Price is not always fixed or binding as the Nepafenac Price is obtained through a variety of data sources. The Nepafenac Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nepafenac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nepafenac, including repackagers and relabelers. The FDA regulates Nepafenac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nepafenac 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 Nepafenac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nepafenac supplier is an individual or a company that provides Nepafenac active pharmaceutical ingredient (API) or Nepafenac finished formulations upon request. The Nepafenac suppliers may include Nepafenac API manufacturers, exporters, distributors and traders.
click here to find a list of Nepafenac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nepafenac DMF (Drug Master File) is a document detailing the whole manufacturing process of Nepafenac active pharmaceutical ingredient (API) in detail. Different forms of Nepafenac DMFs exist exist since differing nations have different regulations, such as Nepafenac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nepafenac DMF submitted to regulatory agencies in the US is known as a USDMF. Nepafenac USDMF includes data on Nepafenac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nepafenac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nepafenac 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 Nepafenac Drug Master File in Japan (Nepafenac JDMF) empowers Nepafenac 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 Nepafenac JDMF during the approval evaluation for pharmaceutical products. At the time of Nepafenac 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 Nepafenac suppliers with JDMF on PharmaCompass.
A Nepafenac written confirmation (Nepafenac WC) is an official document issued by a regulatory agency to a Nepafenac manufacturer, verifying that the manufacturing facility of a Nepafenac active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nepafenac APIs or Nepafenac finished pharmaceutical products to another nation, regulatory agencies frequently require a Nepafenac WC (written confirmation) as part of the regulatory process.
click here to find a list of Nepafenac 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 Nepafenac as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nepafenac 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 Nepafenac 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 Nepafenac and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nepafenac NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nepafenac suppliers with NDC on PharmaCompass.
Nepafenac 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 Nepafenac 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 Nepafenac GMP manufacturer or Nepafenac GMP API supplier for your needs.
A Nepafenac CoA (Certificate of Analysis) is a formal document that attests to Nepafenac's compliance with Nepafenac specifications and serves as a tool for batch-level quality control.
Nepafenac CoA mostly includes findings from lab analyses of a specific batch. For each Nepafenac 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.
Nepafenac may be tested according to a variety of international standards, such as European Pharmacopoeia (Nepafenac EP), Nepafenac JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nepafenac USP).
