- The FDA has issued a warning letter to Sun Pharma due to longstanding and recurrent quality- and compliance-related issues at its Halol manufacturing facility in Gujarat, India. Sun, India's largest drugmaker, saw its shares slump 7% in Monday trading on the news.
- The FDA is dissatisfied with Sun's efforts to fix quality-related issues found during inspections from September of last year. U.S. inspectors noted concerns over the factory's 'sterile environment' along with workers' process for handling quality-test data.
- Sun Pharma is the largest pharmaceutical company in India in terms of revenues from drug sales.
Sun Pharma has faced one compliance-related challenge after another. For example, in August 2014, Sun recalled 400,000 bottles of generic drugs produced at its manufacturing facilities. More recently, the FDA in September revoked approval of Sun's epilepsy drug, Elepsia, because of regulatory compliance issues at the Halol plant.
Sun's management team is working to assure the FDA that problems can be fixed. If they cannot do so, the FDA can issue an import alert barring the factory in question from making medications which could be imported into the U.S.
Sun is re-training the staff at the Halol plant and moving production of some drugs to other plants to hedge against the risk of an import alert. The company hopes to keep moving forward with production, while resolving its regulatory issues.