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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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USDMF
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API Imports and Exports
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Drugs in Development
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
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Dosage Form : Injection
Dosage Strength : 20MG/ML
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Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 100MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 100MG/VIAL
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 1G/VIAL
Packaging :
Approval Date :
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Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 2G/VIAL
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Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 100MG/5ML
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Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 500MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Inj.
Dosage Strength : 1G/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Inj.
Dosage Strength : 100MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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DKSH
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Emulsion
Grade : Topical
Application : Topical
Excipient Details : Triethanolamine is widely used in topical pharmaceutical formulations primarily in the formation of emulsions and sunscreen.
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Film Formers & Plasticizers
Digital Content
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Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Cytarabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cytarabine, including repackagers and relabelers. The FDA regulates Cytarabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cytarabine 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 Cytarabine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cytarabine supplier is an individual or a company that provides Cytarabine active pharmaceutical ingredient (API) or Cytarabine finished formulations upon request. The Cytarabine suppliers may include Cytarabine API manufacturers, exporters, distributors and traders.
click here to find a list of Cytarabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cytarabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Cytarabine active pharmaceutical ingredient (API) in detail. Different forms of Cytarabine DMFs exist exist since differing nations have different regulations, such as Cytarabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cytarabine DMF submitted to regulatory agencies in the US is known as a USDMF. Cytarabine USDMF includes data on Cytarabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cytarabine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cytarabine 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 Cytarabine Drug Master File in Japan (Cytarabine JDMF) empowers Cytarabine 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 Cytarabine JDMF during the approval evaluation for pharmaceutical products. At the time of Cytarabine 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 Cytarabine suppliers with JDMF 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 Cytarabine Drug Master File in Korea (Cytarabine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cytarabine. The MFDS reviews the Cytarabine KDMF as part of the drug registration process and uses the information provided in the Cytarabine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cytarabine 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 Cytarabine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cytarabine suppliers with KDMF on PharmaCompass.
A Cytarabine CEP of the European Pharmacopoeia monograph is often referred to as a Cytarabine Certificate of Suitability (COS). The purpose of a Cytarabine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cytarabine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cytarabine to their clients by showing that a Cytarabine CEP has been issued for it. The manufacturer submits a Cytarabine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cytarabine CEP holder for the record. Additionally, the data presented in the Cytarabine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cytarabine DMF.
A Cytarabine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cytarabine 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 Cytarabine suppliers with CEP (COS) on PharmaCompass.
A Cytarabine written confirmation (Cytarabine WC) is an official document issued by a regulatory agency to a Cytarabine manufacturer, verifying that the manufacturing facility of a Cytarabine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cytarabine APIs or Cytarabine finished pharmaceutical products to another nation, regulatory agencies frequently require a Cytarabine WC (written confirmation) as part of the regulatory process.
click here to find a list of Cytarabine 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 Cytarabine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cytarabine 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 Cytarabine 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 Cytarabine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cytarabine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cytarabine suppliers with NDC on PharmaCompass.
Cytarabine 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 Cytarabine 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 Cytarabine GMP manufacturer or Cytarabine GMP API supplier for your needs.
A Cytarabine CoA (Certificate of Analysis) is a formal document that attests to Cytarabine's compliance with Cytarabine specifications and serves as a tool for batch-level quality control.
Cytarabine CoA mostly includes findings from lab analyses of a specific batch. For each Cytarabine 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.
Cytarabine may be tested according to a variety of international standards, such as European Pharmacopoeia (Cytarabine EP), Cytarabine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cytarabine USP).
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