Strengthening its regulatory pipeline, the company filed 30 additional ANDAs during the year with the USFDA, taking the cumulative filings to 390. The company received 28 ANDA approvals during the year, taking the total to 282 product approvals.
During the year, Zydus Cadila
launched the oral anti-diabetic, Vinglyn (Vildagliptin) and Vinglyn M (Vildagliptin plus Metformin) in India, with the former being one of the most affordable brands for diabetic patients in India.
The company recently announced signing a non-exclusive licensing agreement with Gilead Sciences Inc for manufacturing and distribution of its investigational drug Remdesivir for treating patients suffering from severe symptoms of novel coronavirus (Covid-19).
Zydus, which is also involved in developing a vaccine against the coronavirus, will now also get to manufacture and distribute Remdesivir. The Indian drug maker will receive the manufacturing know-how from Gilead Sciences Inc, to manufacture the API for Remdesivir and the finished product and market it in 127 countries, including India.
Cadila has also been working on a DNA vaccine to fight Covid-19, which is currently in the animal testing stage. The company, in collaboration with ICMR- NIV, Pune, has also manufactured Covid Kavach Elisa test kits for antibody detection with the first batch of 30,000 test kits supplied free of cost to ICMR.
On the other hand, the company also supplied 20 tonnes of hydroxychloroquine (HCQ) with Zydus seeing traction for the drug from other markets as well, said Sharvil Patel, managing director of Cadila Healthcare
in a post-earnings call. Commenting on the lockdown, Patel said that while the company had seen demand erosion due to lesser practice, there were newer opportunities emerging for Zydus.
The company is bullish on requesting a re-audit of its Moraiya plant which had received a warning letter from United States Food and Drug Administration (USFDA) earlier, Patel said in the call.
Meanwhile, during Q4FY20, in a major breakthrough in non-alcoholic liver disease that could prevent liver transplants, Cadila Healthcare
announced the world's first drug for treating non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH).
A new drug application (NDA) for the company's drug - Saroglitazar - was approved by the Drug Controller General of India (DCGI), paving way for its commercial roll out.