Lupin Limited has been granted tentative approval by the US Food and Drug Administration (FDA) for its new drug application (NDA) for HIV drug cocktail – Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) Tablets, 50 mg/300 mg/300 mg, and antiretroviral fixed-dose combination (FDC). The TLD product, which has been approved under the US President’s Emergency […]
Lupin Limited said that its subsidiary Lupin Healthcare (UK) has secured approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for Luforbec (beclometasone dipropionate/formoterol fumarate dihydrate) 100/6 µg pressurized metered dose inhaler (pMDI). Vinita Gupta – CEO of Lupin Limited said: “We are truly delighted to receive the first marketing authorization for generic Fostair […]
Indian pharma company Lupin Limited said that it has been issued a warning letter from the US Food and Drug Administration (FDA) for its manufacturing facility in Somerset, New Jersey. The warning letter follows inspections of the Lupin Somerset site by the FDA from 10 September 2020 to 5 November 2020. Lupin Limited said that […]
Lupin Limited said that its CSR arm – Lupin Foundation is donating five oxygen generation plants to help Maharashtra, Gujarat, and Madhya Pradesh in the treatment of Covid-19 patients. According to the Indian pharma company, the five oxygen plants have a total capacity of 3840 cubic meters of oxygen per day. Lupin Limited said that […]
Indian pharma company Lupin Limited has launched its Digital Asthma Educator platform, which is said to guide asthma patients on the right technique of using inhalers. The new digital asthma platform is the latest initiative under Lupin’s Joint Airways Initiative (JAI) program for patients having respiratory ailments. Lupin said that there an estimated 35 million […]
Lupin Limited (Lupin) said it has secured approval for its Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg, from the US Food and Drug Administration (FDA). Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are a generic equivalent of Truvada Tablets, 200 mg/300 mg from Gilead Sciences. They have approval in combination with other antiretroviral agents […]
Lupin Limited said that it has launched the authorized generic version of Brovana (arformoterol tartrate) Inhalation Solution 15 mcg /2 mL, unit-dose vials, of Sunovion Pharmaceuticals, in the US. Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL has approval in the US for the long-term, twice-daily maintenance treatment of bronchoconstriction in patients having chronic obstructive pulmonary […]
Lupin Limited said that it has signed a royalty-free, limited, non-exclusive voluntary licensing agreement with Eli Lilly and Company (Lilly) for manufacturing and selling the latter’s Baricitinib in India. Baricitinib is an oral JAK1/JAK2 inhibitor for which India’s Central Drugs Standard Control Organization (CDSCO) had been given restricted emergency use in combination with Remdesivir for […]
Indian pharmaceutical company Lupin has entered a landmark agreement to out-license its MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program to US-based biopharmaceutical giant AbbVie. The deal, potentially worth $977 million, grants AbbVie exclusive global rights to develop and commercialize the novel inhibitors. Key highlights of the deal Under the terms of the […]
Lupin Limited, a Mumbai-based generics pharmaceutical company, has strategically broadened its foothold in the women’s health sector by acquiring Symbiomix Therapeutics. The acquisition, valued at $150 million, was executed through Lupin’s US subsidiary, enhancing its presence in the specialized field of women’s health. Strategic Acquisition to Bolster Women’s Health Offerings Symbiomix Therapeutics, founded in 2012 […]