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JDMF
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25081
Submission : 2009-07-20
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Date of Issue : 2025-08-22
Valid Till : 2028-08-21
Written Confirmation Number : WC-0099
Address of the Firm : Plot No.E-50, 50/1 and 59/1, Unit-IV, MIDC, Tarapur-401506, Taluka: Palghar, Dis...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
About the Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Derivatives (Caffeine, e...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Ifosfamide,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Ifoxa® by NanoAlvand Enhances Chemotherapy with Improved Side Effect Profile
Details : Ifoxa (ifosfamide) is a cytotoxic drug that binds to DNA and inhibit DNA synthesis. Ifoxa is indicated for the treatment of malignant diseases.
Product Name : Ifoxa
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
November 30, 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - 1GM/VIAL
USFDA APPLICATION NUMBER - 19763
DOSAGE - INJECTABLE;INJECTION - 3GM/VIAL
USFDA APPLICATION NUMBER - 19763
Related Excipient Companies
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Ifosfamide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ifosfamide manufacturer or Ifosfamide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ifosfamide manufacturer or Ifosfamide supplier.
A Ifex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ifex, including repackagers and relabelers. The FDA regulates Ifex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ifex 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 Ifex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ifex supplier is an individual or a company that provides Ifex active pharmaceutical ingredient (API) or Ifex finished formulations upon request. The Ifex suppliers may include Ifex API manufacturers, exporters, distributors and traders.
click here to find a list of Ifex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ifex DMF (Drug Master File) is a document detailing the whole manufacturing process of Ifex active pharmaceutical ingredient (API) in detail. Different forms of Ifex DMFs exist exist since differing nations have different regulations, such as Ifex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ifex DMF submitted to regulatory agencies in the US is known as a USDMF. Ifex USDMF includes data on Ifex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ifex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ifex suppliers with USDMF on PharmaCompass.
A Ifex CEP of the European Pharmacopoeia monograph is often referred to as a Ifex Certificate of Suitability (COS). The purpose of a Ifex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ifex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ifex to their clients by showing that a Ifex CEP has been issued for it. The manufacturer submits a Ifex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ifex CEP holder for the record. Additionally, the data presented in the Ifex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ifex DMF.
A Ifex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ifex 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 Ifex suppliers with CEP (COS) on PharmaCompass.
A Ifex written confirmation (Ifex WC) is an official document issued by a regulatory agency to a Ifex manufacturer, verifying that the manufacturing facility of a Ifex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ifex APIs or Ifex finished pharmaceutical products to another nation, regulatory agencies frequently require a Ifex WC (written confirmation) as part of the regulatory process.
click here to find a list of Ifex 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 Ifex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ifex 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 Ifex 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 Ifex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ifex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ifex suppliers with NDC on PharmaCompass.
Ifex 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 Ifex GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ifex GMP manufacturer or Ifex GMP API supplier for your needs.
A Ifex CoA (Certificate of Analysis) is a formal document that attests to Ifex's compliance with Ifex specifications and serves as a tool for batch-level quality control.
Ifex CoA mostly includes findings from lab analyses of a specific batch. For each Ifex 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.
Ifex may be tested according to a variety of international standards, such as European Pharmacopoeia (Ifex EP), Ifex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ifex USP).
