Mumbai, Amman, February 1, 2022: Global pharma major, Lupin Limited (Lupin) announced today that they have entered into a License, Supply and Technology Sharing agreement with Axantia Holding (Axantia), a leading pharmaceutical company in the region 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 U.S. FDA 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.
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 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.
The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions. The company invested 9.6% of its revenue on research and development in FY21.
Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
Please visit www.lupin.com for more information.
Axantia is a leading pharmaceutical company, established in 2014 as a joint venture between Abu Al Haj Family and Al Faisaliah Group. Axantia develops, manufactures, markets, and distributes high-quality branded generic pharmaceuticals and under-licensed products in 20 countries across the Middle East, Africa, and the CIS.
Axantia was established to deliver high-quality and affordable medicines, exploit scale, and foresee and respond to new opportunities and risks.
Axantia’s subsidiaries – Pharma International Company in Jordan and Med City Pharmaceutical Industries in Saudi Arabia are supported by functional organizations with different manufacturing lines to deliver a broad portfolio covering all major therapeutic areas.
Axantia has a general formulations plant in Jeddah and has the renovated 3 plants in Amman Jordan; GF plant, Cepha plant and Injectable Cepha plant. Axantia is well‐placed to be the partner of choice for companies looking to establish business in the MENA region.
Please visit www.Axantia.com for more information.
Follow us on LinkedIn: https://www.linkedin.com/company/axantiagroup
For further information or queries please contact –
Vice President & Global Head – Corporate Communications