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JDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
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Data Compilation #PharmaFlow
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API SUPPLIERS
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
SWATI – Transforming science into solutions with 50+ years of expertise, global accreditations, and pioneering biotech innovation.
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USDMF
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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 ...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API / Semi finish form...
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
About the Company : JPN Pharma is a premier pharmaceutical company in India, specializing in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug intermediates. Headq...
SWATI – Transforming science into solutions with 50+ years of expertise, global accreditations, and pioneering biotech innovation.
About the Company : SWATI is a global research-oriented company with a vision to transform science into market-ready solutions. With over 50 years of expertise and 25 years dedicated to neglected dise...
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API Imports and Exports
Drugs in Development
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DOSAGE - INJECTABLE;INJECTION - 50MG/ML
USFDA APPLICATION NUMBER - 84307
DOSAGE - CAPSULE;ORAL - 100MG EXTENDED
USFDA APPLICATION NUMBER - 84349
DOSAGE - CAPSULE;ORAL - 30MG EXTENDED
USFDA APPLICATION NUMBER - 84349
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Coating Systems & Additives
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Film Formers & Plasticizers
Empty Capsules
Rheology Modifiers
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Digital Content
NEWS #PharmaBuzz
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Phenytoin Sodium 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 Phenytoin Sodium manufacturer or Phenytoin Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phenytoin Sodium manufacturer or Phenytoin Sodium supplier.
PharmaCompass also assists you with knowing the Phenytoin Sodium API Price utilized in the formulation of products. Phenytoin Sodium API Price is not always fixed or binding as the Phenytoin Sodium Price is obtained through a variety of data sources. The Phenytoin Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Epamin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epamin, including repackagers and relabelers. The FDA regulates Epamin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epamin 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 Epamin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epamin supplier is an individual or a company that provides Epamin active pharmaceutical ingredient (API) or Epamin finished formulations upon request. The Epamin suppliers may include Epamin API manufacturers, exporters, distributors and traders.
click here to find a list of Epamin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Epamin DMF (Drug Master File) is a document detailing the whole manufacturing process of Epamin active pharmaceutical ingredient (API) in detail. Different forms of Epamin DMFs exist exist since differing nations have different regulations, such as Epamin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Epamin DMF submitted to regulatory agencies in the US is known as a USDMF. Epamin USDMF includes data on Epamin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Epamin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Epamin suppliers with USDMF on PharmaCompass.
A Epamin CEP of the European Pharmacopoeia monograph is often referred to as a Epamin Certificate of Suitability (COS). The purpose of a Epamin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Epamin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Epamin to their clients by showing that a Epamin CEP has been issued for it. The manufacturer submits a Epamin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Epamin CEP holder for the record. Additionally, the data presented in the Epamin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Epamin DMF.
A Epamin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Epamin 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 Epamin suppliers with CEP (COS) on PharmaCompass.
A Epamin written confirmation (Epamin WC) is an official document issued by a regulatory agency to a Epamin manufacturer, verifying that the manufacturing facility of a Epamin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Epamin APIs or Epamin finished pharmaceutical products to another nation, regulatory agencies frequently require a Epamin WC (written confirmation) as part of the regulatory process.
click here to find a list of Epamin 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 Epamin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Epamin 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 Epamin 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 Epamin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Epamin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Epamin suppliers with NDC on PharmaCompass.
Epamin 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 Epamin 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 Epamin GMP manufacturer or Epamin GMP API supplier for your needs.
A Epamin CoA (Certificate of Analysis) is a formal document that attests to Epamin's compliance with Epamin specifications and serves as a tool for batch-level quality control.
Epamin CoA mostly includes findings from lab analyses of a specific batch. For each Epamin 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.
Epamin may be tested according to a variety of international standards, such as European Pharmacopoeia (Epamin EP), Epamin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Epamin USP).
