Lupin intimated that they have entered into a license, supply and technology sharing agreement with Axantia Holding (Axantia), operating through its pharmaceutical subsidiaries - Pharma International Company and Med City Pharmaceutical Industries.
Under the terms of agreement, Axantia will register, distribute and market biosimilar Pegfilgrastim Drug Product in certain territories including Saudi Arabia, certain GCC countries, Jordan, Lebanon, Iraq, Sudan, Libya and Algeria.
Lupin had earlier received the US-based drug regulatory body, United States Food & Drug Administration (USFDA)'s acceptance for review of the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.
Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy.
The company reported a consolidated net loss of Rs 2,094.87 crore in Q2 FY22 as against net profit of Rs 213.51 crore in Q2 FY21. On a consolidated basis, net sales rose 5.9% to Rs 4,003.42 crore in Q2 FY22 over Q2 FY21.
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Lupin is a transnational pharmaceutical company. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
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