Committed to being current good manufacturing practice (cGMP) compliant and supplying high-quality products to its customers, Sun Pharma
has said that it continues to cooperate with the USFDA
and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with its remedial action.
While the exact share of Halol plant in US exports is not known, analysts estimate its share in total revenues to be in high-single digits. Earlier in a post-earnings call, Sun Pharma's managing director and executive director Dilip Shantilal Shanghvi had told analysts that post a warning letter from USFDA, the size of dependence on Halol facility for US exports would have gone down.
As such, post USFDA observations in December 2019, the company was expected to spend considerably to ramp up procedures and facilities at Halol even as some observations would have required comprehensive explanations and responses by Sun Pharma.
For now, analysts feel not many new drug filings can be expected from Halol in near term even as future drug approvals from the plant becomes crucial.