Lasa Supergenerics gets FDA nod for Progesterone
Mumbai: API producer, 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.
Commenting on the development, Dr Omkar Herlekar, Chairman– Lasa Supergenerics Limited, "The trial batches have already been carried out and we are in good stead to start manufacturing from the current month itself. We are amongst few in the world to manufacture progesterone with novel technology, anticipating a shortage in domestic requirements, Progesterone is 1 of the 26 drugs that had a restriction for exports due to the COVID 19 situation due to India's import dependencies on Chinese Suppliers. Though the ban was lifted by the DGFT on April 6, except for paracetamol, it seems in the times to come 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 2/3 of the $400 mn hormone and steroid API market which has a huge demand even in ROW countries.
Progesterone is almost a 250 MT annual market spread over demand of over several Indian formulators including pharma mnc's. Currently, local demand is catered mostly by imports from China. Other than domestic business, the export potential is almost to the tune of 150 MT in ROW countries which anticipates total market of progesterone at approximately $80 mn., This foray may lead us to expand the existing facilities to add capacities and capabilities to manufacture other hormonal drugs too"
Additionally mentions, Progesterone is a female sex hormone. It's produced mainly in the ovaries it's a crucial part of the menstrual cycle and maintenance of pregnancy. It is used in the treatment of Amenorrhea, the absence of menstrual periods. It is used with estrogen in the Hormone Replacement Therapy (HRT). It is also used in the infertility treatment for women.
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. Its efforts are underway, it currently seeks necessary permissions from DCGI for conducting bioequivalence clinical trials in India to showcase its effectiveness and get into a full-scale production with the support of the government or strategic investments or tie-ups.