Synopsis
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JDMF
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
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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 : 35313
Submission : 2021-01-21
Status :
Type : II
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 : 37086
Submission : 2022-05-02
Status :
Type : II
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Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Cyclophosphamide Ph. Eur/BP/USP
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...
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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 pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
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...
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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
Lead Product(s) : Cyclophosphamide,Dexamethasone,Isatuximab,Alogeneic Tgfbi Expanded NK Cell
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Elvira Umyarova
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cyclophosphamide is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Multiple Myeloma.
Product Name : Undisclosed
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
January 12, 2024
Lead Product(s) : Dexamethasone, Fludarabine Phosphate, Cytarabine, Daunorubicin, Idarubicin Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Isatuximab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
March 04, 2019
Lead Product(s) : Capecitabine,Cyclophosphamide
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Capecitabine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Breast Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 26, 2016
Lead Product(s) : Lenalidomide,Bortezomib,Cyclophosphamide,Dexamethasone,Isatuximab
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Lenalidomide is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Multiple Myeloma.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 31, 2015
Lead Product(s) : Cyclophosphamide,Doxorubicin Hydrochloride,Vincristine Sulfate,Prednisone
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Fernando Cabanillas
Deal Size : Inapplicable
Deal Type : Inapplicable
Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL
Details : Cyclophosphamide is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Lymphoma.
Product Name : Undisclosed
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
February 07, 2012
Lead Product(s) : Epcoritamab,Cyclophosphamide,Rituximab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Two Data Analyses Show Epcoritamab Induces Durable Complete Responses
Details : Tepkinly (epcoritamab) is an IgG1-bispecific antibody, which is evaluated for the treatment of diffuse large B-cell lymphoma. It is designed to direct cytotoxic T cells selectively.
Product Name : Tepkinly
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
December 09, 2024
Lead Product(s) : Dexamethasone, Vincristine Sulfate, Cytarabine, Etoposide, Azacitidine
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Genentech
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dexamethasone is a Steroid drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Neoplasms.
Product Name : Undisclosed
Product Type : Steroid
Upfront Cash : Inapplicable
August 02, 2017
Lead Product(s) : Cyclophosphamide,Doxorubicin Hydrochloride,Paclitaxel,Carboplatin,Veliparib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : GBG Forschungs GmbH | NSABP Foundation | Grupo Español de Investigación del Cáncer de Mama | US Oncology Research
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cyclophosphamide is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Triple Negative Breast Neoplasms.
Product Name : Undisclosed
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
January 10, 2014
Lead Product(s) : Ibrutinib, Etoposide, Prednisone, Doxorubicin Hydrochloride, Cyclophosphamide
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Celgene Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ibrutinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Lymphoma, Large B-Cell, Diffuse.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 20, 2014
Lead Product(s) : Cyclophosphamide,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Endoxyna®; A Crucial Medication with A Novel Solution Formulation
Details : Endoxyna is a novel liquid formulation of cyclophosphamide, to replace the previous freeze-dried products. It is indicated for the treatment of cancer
Product Name : Endoxyna
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
June 29, 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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DOSAGE - INJECTABLE;INJECTION - 100MG/VIAL **...DOSAGE - INJECTABLE;INJECTION - 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12142
DOSAGE - INJECTABLE;INJECTION - 1GM/VIAL **Fe...DOSAGE - INJECTABLE;INJECTION - 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12142
DOSAGE - INJECTABLE;INJECTION - 200MG/VIAL **...DOSAGE - INJECTABLE;INJECTION - 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12142
DOSAGE - INJECTABLE;INJECTION - 2GM/VIAL **Fe...DOSAGE - INJECTABLE;INJECTION - 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12142
DOSAGE - INJECTABLE;INJECTION - 500MG/VIAL **...DOSAGE - INJECTABLE;INJECTION - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12142
DOSAGE - CAPSULE;ORAL - 25MG
USFDA APPLICATION NUMBER - 203856
DOSAGE - CAPSULE;ORAL - 50MG
USFDA APPLICATION NUMBER - 203856
DOSAGE - SOLUTION;INTRAVENOUS - 1GM/5ML (200M...DOSAGE - SOLUTION;INTRAVENOUS - 1GM/5ML (200MG/ML)
USFDA APPLICATION NUMBER - 212501
DOSAGE - SOLUTION;INTRAVENOUS - 2GM/10ML (200...DOSAGE - SOLUTION;INTRAVENOUS - 2GM/10ML (200MG/ML)
USFDA APPLICATION NUMBER - 212501
DOSAGE - SOLUTION;INTRAVENOUS - 500MG/2.5ML (...DOSAGE - SOLUTION;INTRAVENOUS - 500MG/2.5ML (200MG/ML)
USFDA APPLICATION NUMBER - 212501
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Cyclophosphamide 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 Cyclophosphamide manufacturer or Cyclophosphamide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cyclophosphamide manufacturer or Cyclophosphamide supplier.
PharmaCompass also assists you with knowing the Cyclophosphamide API Price utilized in the formulation of products. Cyclophosphamide API Price is not always fixed or binding as the Cyclophosphamide Price is obtained through a variety of data sources. The Cyclophosphamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A C07888 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of C07888, including repackagers and relabelers. The FDA regulates C07888 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. C07888 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 C07888 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A C07888 supplier is an individual or a company that provides C07888 active pharmaceutical ingredient (API) or C07888 finished formulations upon request. The C07888 suppliers may include C07888 API manufacturers, exporters, distributors and traders.
click here to find a list of C07888 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A C07888 DMF (Drug Master File) is a document detailing the whole manufacturing process of C07888 active pharmaceutical ingredient (API) in detail. Different forms of C07888 DMFs exist exist since differing nations have different regulations, such as C07888 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A C07888 DMF submitted to regulatory agencies in the US is known as a USDMF. C07888 USDMF includes data on C07888's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The C07888 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of C07888 suppliers with USDMF on PharmaCompass.
A C07888 CEP of the European Pharmacopoeia monograph is often referred to as a C07888 Certificate of Suitability (COS). The purpose of a C07888 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of C07888 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of C07888 to their clients by showing that a C07888 CEP has been issued for it. The manufacturer submits a C07888 CEP (COS) as part of the market authorization procedure, and it takes on the role of a C07888 CEP holder for the record. Additionally, the data presented in the C07888 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the C07888 DMF.
A C07888 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. C07888 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 C07888 suppliers with CEP (COS) on PharmaCompass.
A C07888 written confirmation (C07888 WC) is an official document issued by a regulatory agency to a C07888 manufacturer, verifying that the manufacturing facility of a C07888 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting C07888 APIs or C07888 finished pharmaceutical products to another nation, regulatory agencies frequently require a C07888 WC (written confirmation) as part of the regulatory process.
click here to find a list of C07888 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 C07888 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for C07888 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 C07888 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 C07888 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a C07888 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of C07888 suppliers with NDC on PharmaCompass.
C07888 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 C07888 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 C07888 GMP manufacturer or C07888 GMP API supplier for your needs.
A C07888 CoA (Certificate of Analysis) is a formal document that attests to C07888's compliance with C07888 specifications and serves as a tool for batch-level quality control.
C07888 CoA mostly includes findings from lab analyses of a specific batch. For each C07888 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.
C07888 may be tested according to a variety of international standards, such as European Pharmacopoeia (C07888 EP), C07888 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (C07888 USP).
