Zydus Cadila Receives USFDA's Approval to Commercialize Empagliflozin and Linagliptin Tablets

THD NewsDesk, AHMEDABAD: International drug firm Zydus Cadila has received permission from the US Food and Drug Administration (USFDA) to market Empagliflozin and Linagliptin tablets. The FDA gave its tentative approval to the India-based pharmaceutical company to retail generic diabetes drugs in the US market. 

The USFDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. 

Empagliflozin and Linagliptin tablets lower blood sugar levels in adults with Type-2 Diabetes Mellitus. Doctors generally advise the intake of these tablets with regular exercise and a controlled diet to keep the sugar level in check. Zydus secured the authorization to sell these drugs in the strengths of 10/5 mg and 25/5 mg, said the drug firm in a statement.

Zydus Cadila is headquartered in Ahmedabad and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil. The diabetes drug would also be developed at the manufacturing facility at its SEZ, Ahmedabad itself. 

Zydus Cadila was also the first drug firm to launch the most affordable Covid-19 drug Remdesivir in India. Till now, the group has secured 299 approvals and has filed 390 abbreviated new drug applications so far.