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Lasa Supergenerics gets FDA nod for progesterone API

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Progesterone is one of the 26 drugs that had a restriction for exports due to COVID 19 pandemic as a result of India’s import dependency on Chinese suppliers

API producer, Lasa Supergenerics has received approval the Food and Drug Administration authorities to manufacture Progesterone, a steroid hormone, at its WHO GMP certified facility at Mahad Industrial Area. This marks the company’s foray into the hormone and steroid API segment for human application.

Dr Omkar Herlekar, Chairman, Lasa Supergenerics said “The trial batches have already been carried out and we are in good stead to start manufacturing from the current month itself. This foray may lead us to expand the existing facilities to add capacities and capabilities to manufacture other hormonal drugs too.”

“The progestin hormone is naturally occurring to women but growing demand for this drug comes due to increasing occurrences of infections to the likes of amenorrhea, uterine tumour, breast cancer and lifestyle caused issues such as infertility, absence of menstrual periods besides its use in contraceptive pills. The market for this drug has been anticipated to grow at a 14 per cent CAGR and is dominated by the North American markets followed by Asia Pacific and Europe,” he added.

Progesterone is one of the 26 drugs that had a restriction for exports due to the COVID 19 situation as a result of India’s import dependency on Chinese suppliers. The Hubei province of China caters to more than two-thirds of the $400 million hormone and steroid API market which has a huge demand even in ROW countries.

Lasa had earlier announced its collaboration with ICT to work on the Favipiravir molecule considering it as a promising antiviral to treat the deadly COVID 19 virus due to its RNA capabilities against many viruses such as influenza and Ebola. Reportedly, it is currently seeking necessary permissions from DCGI for conducting bioequivalence clinical trials in India to showcase its effectiveness and get into full-scale production with the support of the government or strategic investments or tie-ups.

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