Team of US FDA (Food and Drug Administration) inspectors, which recently conducted a surprise audit on a Gujarat unit of Sun Pharmaceutical Industries, has reportedly submitted Form 483. Submission of Form 483 means the FDA team found certain procedural issues with respect to the plant's running and seeks corrective action but may not imply an immediate import ban.
The FDA team has made 23 observations (four for injectable units, four for oral solid unit and rest for the quality-control lab) at the Halol unit in Gujarat, which accounts for about 25 percent of Sun’s US sales. The US market accounts for 60 percent of the company’s total sales. Though, the FDA did not find any data integrity issues with the plant.
Sun Pharmaceutical Industries is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1675.20 |
| Dr. Reddys Lab | 1235.40 |
| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
| View more.. | |
MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.
To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.
MoneyWorks4Me ensures this through: