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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-29
Pay. Date : 2012-11-08
DMF Number : 13726
Submission : 1998-09-01
Status :
Type : II
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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...
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, ...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
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 ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
About the Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and new modalities such as...
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API Imports and Exports
Drugs in Development
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DOSAGE - INJECTABLE;INJECTION - 150MG/75ML
USFDA APPLICATION NUMBER - 50629
DOSAGE - INJECTABLE;INJECTION - 200MG/100ML
USFDA APPLICATION NUMBER - 50629
DOSAGE - INJECTABLE;INJECTION - 2MG/ML
USFDA APPLICATION NUMBER - 50629
DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 20...DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 20MG/10ML (2MG/ML)
USFDA APPLICATION NUMBER - 50718
DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 50...DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 50MG/25ML (2MG/ML)
USFDA APPLICATION NUMBER - 50718
Related Excipient Companies
Gangwal Healthcare
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Fillers, Diluents & Binders
Granulation
Direct Compression
Thickeners and Stabilizers
Co-Processed Excipients
Solubilizers
Emulsifying Agents
Taste Masking
Coating Systems & Additives
Surfactant & Foaming Agents
Topical
Digital Content
DATA COMPILATION #PharmaFlow
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Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Doxorubicin Hydrochloride 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 Doxorubicin Hydrochloride manufacturer or Doxorubicin Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Doxorubicin Hydrochloride manufacturer or Doxorubicin Hydrochloride supplier.
PharmaCompass also assists you with knowing the Doxorubicin Hydrochloride API Price utilized in the formulation of products. Doxorubicin Hydrochloride API Price is not always fixed or binding as the Doxorubicin Hydrochloride Price is obtained through a variety of data sources. The Doxorubicin Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Caelyx manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Caelyx, including repackagers and relabelers. The FDA regulates Caelyx manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Caelyx 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 Caelyx manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Caelyx supplier is an individual or a company that provides Caelyx active pharmaceutical ingredient (API) or Caelyx finished formulations upon request. The Caelyx suppliers may include Caelyx API manufacturers, exporters, distributors and traders.
click here to find a list of Caelyx suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Caelyx DMF (Drug Master File) is a document detailing the whole manufacturing process of Caelyx active pharmaceutical ingredient (API) in detail. Different forms of Caelyx DMFs exist exist since differing nations have different regulations, such as Caelyx USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Caelyx DMF submitted to regulatory agencies in the US is known as a USDMF. Caelyx USDMF includes data on Caelyx's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Caelyx USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Caelyx 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 Caelyx Drug Master File in Japan (Caelyx JDMF) empowers Caelyx 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 Caelyx JDMF during the approval evaluation for pharmaceutical products. At the time of Caelyx 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 Caelyx 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 Caelyx Drug Master File in Korea (Caelyx KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Caelyx. The MFDS reviews the Caelyx KDMF as part of the drug registration process and uses the information provided in the Caelyx KDMF to evaluate the safety and efficacy of the drug.
After submitting a Caelyx 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 Caelyx API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Caelyx suppliers with KDMF on PharmaCompass.
A Caelyx CEP of the European Pharmacopoeia monograph is often referred to as a Caelyx Certificate of Suitability (COS). The purpose of a Caelyx CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Caelyx EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Caelyx to their clients by showing that a Caelyx CEP has been issued for it. The manufacturer submits a Caelyx CEP (COS) as part of the market authorization procedure, and it takes on the role of a Caelyx CEP holder for the record. Additionally, the data presented in the Caelyx CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Caelyx DMF.
A Caelyx CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Caelyx 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 Caelyx suppliers with CEP (COS) on PharmaCompass.
A Caelyx written confirmation (Caelyx WC) is an official document issued by a regulatory agency to a Caelyx manufacturer, verifying that the manufacturing facility of a Caelyx active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Caelyx APIs or Caelyx finished pharmaceutical products to another nation, regulatory agencies frequently require a Caelyx WC (written confirmation) as part of the regulatory process.
click here to find a list of Caelyx 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 Caelyx as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Caelyx 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 Caelyx 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 Caelyx and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Caelyx NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Caelyx suppliers with NDC on PharmaCompass.
Caelyx 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 Caelyx 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 Caelyx GMP manufacturer or Caelyx GMP API supplier for your needs.
A Caelyx CoA (Certificate of Analysis) is a formal document that attests to Caelyx's compliance with Caelyx specifications and serves as a tool for batch-level quality control.
Caelyx CoA mostly includes findings from lab analyses of a specific batch. For each Caelyx 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.
Caelyx may be tested according to a variety of international standards, such as European Pharmacopoeia (Caelyx EP), Caelyx JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Caelyx USP).
