Lupin receives FDA approval for generic Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg
Mumbai, Baltimore, July 12, 2018: Pharma major Lupin announced that it has received final approval for its Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg from the United States Food and Drug Administration (FDA) to market a generic version of Alvogen Malta Operations Ltd.’s Macrodantin® Capsules, 50 mg and 100 mg.
Lupin’s Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg is the generic version of Alvogen Malta Operations Ltd.’s Macrodantin® Capsules, 50 mg and 100 mg. It is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.
Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg had annual sales of approximately USD 27 million in the US (IQVIA MAT April 2018).
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 12th and 8th largest generics pharmaceutical company by market capitalization (31st March 2018, Bloomberg) and revenues (31st Mar 2018, Bloomberg LTM) respectively. The Company is the 4th largest pharmaceutical player in the US by prescriptions (IQVIA MAT March 2018); 3rd largest Indian pharmaceutical company by global revenues (31st Mar 2018, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT March 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 –http://www.twitter.com/lupinglobal
CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
For further information or queries, please contact –
VP – Corporate Communications
Ph: +91-22-66402531 / 8291013225
Head – Investor Relations
*Safe Harbor Statement
Macrodantin® Capsules is a registered trademark of Alvogen US IP Holdings 2, LLC.