Dr. Reddy's Laboratories, Incorporated

Avyxa Holdings, LLC

Svb Janardhan Garikipati

Harshal Bhagwatwar

Riyaz Ahmed Shaik

Ananya Saha

Bhavesh Vallabhbhai Patel

Akash Chaurasiya

Sumitra Ashok Pillai

Satheesh Balasubramanian

Joydeep Mazumder

The present invention relates to stable liquid pharmaceutical formulations of cyclophosphamide comprising cyclophosphamide and at least one pharmaceutically acceptable excipient wherein moisture content of the liquid formulation is less than about 2.0% by weight. The invention further relates to stable liquid formulations of cyclophosphamide prepared by a process comprising a step of reducing the moisture content from cyclophosphamide or liquid compositions of cyclophosphamide or both. The invention further relate to method of using such stable liquid formulations of cyclophosphamide for parenteral administration either as ready-to-use or ready-to-dilute for treating various cancer disorders.

Stable liquid formulations of cyclophosphamide and processes to prepare the same

The present invention relates to novel impurities of cyclophosphamide having structure V, VI or VII, stabilized form of these novel impurities, a process of preparing a stabilized form and isolating thereof. The invention also relates cyclophosphamide formulations which include cyclophosphamide, at least one pharmaceutically acceptable excipient, and a certain level of these impurities having structure V, VI or VII. The invention further relate to method of using such stable liquid formulations of cyclophosphamide for parenteral administration in treating various cancer disorders.

Stable liquid formulations of cyclophosphamide and its impurities

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Visakhapatnam, India

Svb Janardhan Garikipati