Mumbai: Pharma major Lupin Limited (Lupin) announced today that it has received the ‘European Good Manufacturing Practice’ (EU GMP) certificate for its Mammalian Facility in Pune where Etanercept Biosimilar is intended to be manufactured.
This GMP certification further confirms that Lupin has a robust manufacturing facility that ensures consistent and controlled production as per EU quality standards.
Commenting on this development, Mr. Nilesh Gupta, Managing Director, Lupin Limited stated, “Etanercept is a complex product that requires a sophisticated development facility for production. The EU GMP certificate is a noteworthy achievement by the Biotech manufacturing team. With this timely approval of our biotech facility we are well on track to start preparing for the manufacture and launch of our Etanercept Biosimilar for Europe. This will enable us to offer a high-quality option that helps reducing healthcare expenses”.
“Etanercept is used globally in the fight against a range of severe autoimmune disorders. The successful approval of the facility is testament to our quality and compliance standards and is a major step in achieving our goal for market entry in to Europe post approval of the product,” said Dr. Cyrus Karkaria, President, Lupin Biotech. “After significant investment in our biotechnology R&D division over the years, this is the first biosimilar for regulated markets developed and manufactured in-house at Lupin. It is an important achievement for us and sets the tone for future biosimilar development.”
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.
Lupin is the 8th largest generics pharmaceutical company in terms of market capitalization (28th December 2018, Bloomberg) and the 8th largest generics pharmaceutical company in terms of revenues (30th September 2018, Bloomberg LTM) globally. The Company is the 3rd largest pharmaceutical player in the US by prescriptions for the Total Market (IQVIA MAT December 2018); 3rd largest Indian pharmaceutical company by global revenues (30th September 2018, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan (IQVIA MAT December 2018) and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT December 2018).
For the financial year ended 31st March, 2018, Lupin’s Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinglobal
CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
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