BackShilpa Medicare gets USFDA approval for API plants in Karnataka
The inspection by the US Food and Drug Administration for Shilpa Medicare to sell active pharmaceutical ingredients took place in November
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Hyderabad: Drug maker Shilpa Medicare Ltd on Thursday said it has received a compliance letter from the US Food and Drug Administration (USFDA) for two of its plants at Raichur, Karnataka, allowing it to sell active pharmaceutical ingredients (APIs) in the US markets.
The two API manufacturing sites are Unit 1 in Deosagar industrial area and Unit 2 at Raichur industrial growth centre.
The inspection for these sites took place in November. The company, which makes both APIs and formulations, had so far exported mostly to European countries and had not entered the US markets.
Its formulations facility at Jadcherla in Telangana also was inspected by the USFDA in December last year. On this, the company expects to hear back from the USFDA by April. With necessary approvals in place, it can now start selling in the US markets.
The company’s products are in areas of oncology, antiretrovirals and unmet medical needs. According to an IIFL research report in June last year, Shilpa Medicare has filed around 12 abbreviated new drug applications.
Entering the US markets could help the company’s boost its revenues by 10% in fiscal 2017, the management had indicated last year.
The company has eight manufacturing facilities, of which seven are in India. In December last year, Shilpa Medicare also got a go-ahead from the Reserve Bank of India allowing foreign institutional investors and registered foreign portfolio investors to invest up to 30% of the paid-up capital in the company. Promoters’ holding in the company is 53.05%.
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