Lasa receives FDA nod for Progesterone

Lasa Supergenerics Ltd. has forayed into the hormone and steroid API segment for human application with its approval from the Food and Drug Administration authorities to manufacture Progesterone, a steroid hormone, at its WHO GMP-certified facility at Mahad Industrial Area. Progesterone is almost a 250-MT annual market, spread over demand of over several Indian formulators including pharma MNCs. Currently, the local demand is catered mostly by imports from china. Other than domestic business, export potential is almost to the tune of 150 MT in ROW countries, which anticipates total market of progesterone at approximately USD 80 million. This foray may lead us to expanding the existing facilities to add capacities and capabilities to manufacture other hormonal drugs too.

The company 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 owing to its RNA capabilities against many viruses such as influenza and Ebola. Its efforts are underway. The company currently seeks necessary permissions from the 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.

Dr Omkar Herlekar
Chairman,
Lasa Supergenerics Limited

“The trial batches have already been carried out and we are in a good stead to start manufacturing from the current month itself. We are amongst the few in the world to manufacture Progesterone with novel technology, anticipating a shortage in domestic requirements. Progesterone is one of the 26 drugs that had a restriction for exports owing to the COVID-19 situation because of India’s import dependencies on Chinese suppliers. Though the ban was lifted by the DGFT on April 6, except for paracetamol, it seems there is going to be a huge demand-supply gap to be addressed in the times to come. The Hubei province of China caters to more than two-thirds of the USD 400 million hormone and steroid API market, which has a huge demand even in ROW countries.”

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