Indian pharma titan Lupin has announced receiving approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule. This medication is a generic equivalent of Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder), an 18 mcg/capsule product of Boehringer Ingelheim Pharmaceuticals, Inc. Lupin will manufacture this […]
Indian pharmaceutical company Lupin Limited has appointed Spiro Gavaris as president of its US generics business. Spiro Gavaris, who will be a part of the senior leadership team of the company, will handle the overall strategy, implementation, and expansion of the American generics business in the US. According to Lupin, Spiro Gavaris joins the company […]
Lupin Limited has agreed to acquire all rights to a couple of inhalation medicines, namely Brovana (arformoterol tartrate) Inhalation Solution and Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, from Sunovion Pharmaceuticals for $75 million. The Indian pharma company anticipates the deal to be incremental to earnings in the first year. According to Lupin, the acquisition of […]
Indian pharmaceutical company Lupin announced that Dr. Shahin Fesharaki has been appointed as Global Chief Scientific Officer who will handle global research and development works across generics, branded, and specialty products. Vinita Gupta – Lupin CEO and Lupin MD Nilesh Gupta said: “We are very pleased to welcome Shahin to our leadership team. Shahin’s exceptional […]
Indian pharma company Lupin Pharmaceuticals has signed an agreement with Exeltis USA to promote its antimicrobial drug Solosec (secnidazole) in the US market. Solosec is an approved drug in the US, which is used for treating bacterial vaginosis in adult women and trichomoniasis in adults. Bacterial vaginosis is known to be a common vaginal infection, […]
Lupin Limited said that it has been issued the establishment inspection report (EIR) from the US Food and Drug Administration (US FDA) for its manufacturing facility in Goa following an inspection in September 2021. The US FDA determined that the inspection classification of the Goa manufacturing facility is voluntary action indicated (VAI). Voluntary Action Indicated […]
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 […]