Analysts said observations pertained to deficiencies in healthy manufacturing practices. “FDA is raising questions with regard to sterility and quality, which are key requirements for an injectable plant,” one of them said, and added that product approvals could get delayed after the findings. “What is required is capacity-building and developing quality culture,” another analyst remarked.
In July, the company received its maiden approval from the regulator following clearance for an oncology injectable, with a market size of $35 million. Halol plant was served a warning letter in December 2015 and no products had been approved from the plant since 2014.
The resolution of Halol plant was critical for revival of Sun Pharma's US business, which contributed around 35 per cent of its consolidated sales in the last fiscal. Analysts expect Halol plant's resolution could add to $100 million in the revenue annually. The company has reported for low double-digit growth in 2018-19, and is targeting growth from all markets.