Lupin clinches FDA approval for generic Spiriva HandiHaler

Lupin clinches FDA approval for generic Spiriva HandiHaler

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 […]

Lupin ropes in Spiro Gavaris as US generics business president

Lupin ropes in Spiro Gavaris as US generics business president

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 to acquire rights to Brovana and Xopenex HFA for $75m

Lupin to acquire rights to Brovana and Xopenex HFA for $75m

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 […]

Shahin Fesharaki appointed as Lupin Global Chief Scientific Officer

Shahin Fesharaki appointed as Lupin Global Chief Scientific Officer

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 […]

Lupin gets EIR with voluntary action indicated from FDA for Goa facility

Lupin gets EIR with voluntary action indicated from FDA for Goa facility

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 gets approval for Luforbec 100/6 µg pMDI in UK

Lupin Limited gets approval for Luforbec 100/6 µg pMDI in UK

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 […]