India-based private sector healthcare firm Sun Pharmaceuticals Industries Limited has been on the top list of the United States Food and Drug Administration (FDA) and has also received yet another notice from the health regulator after the concerned Authorities inspected the Halol manufacturing plant located in western part of Gujarat which was earlier banned from manufacturing any new medicine. The Authorities of the company said that the inspection was done on December 1 and last week they have received a form 483 observation letter from USDA asking for a reply within 15 days time span. The United States Food And Drug Administration previously also unapproved a few key medicinal drugs manufactured by Sun Pharmacy and has also been issued a warning letter in terms of violating a number of terms and norms in the Indian Plant. After this all happened around 11:44pm the shares of the company Sun Pharmaceutical came down by four percent to trade at Rs. 677.45 at the National Stock Exchange.
Well, it’s nothing new for the Sun Pharmaceuticals that they are facing this notice issue against Halol plant for violating protocols because in the year 2014 and 2015 in the month of September and December respectively they have been warned through the notice followed by an inspection for the facility segment. In the latest notice, a Form 483 issued by (FDA) after a complete inspection of the Halol plant on December 1, to Sun Pharmaceuticals defines that FDA has found such spots and conditions that may constitute the violation under the United States Food and Drug and Cosmetic (FD&C) Acts. Whereas, the Sun Pharmaceuticals have did not give the details on the number and nature of the observation mentioned in Form 483. Typically, the FDA does not make such findings public themselves.
Dilip Shanghavi, Founder and Managing Director of Sun Pharmaceuticals Industries Limited has stated in one of the interviews that Halol the Gujarat unit is the integral part the entire Sun Pharmaceuticals from where they have filed injectable products and it is the only site for filing the injectable products for Sun Pharmaceuticals so, it will always be the most important site for Sun Pharmaceutical Industries. Hence, clearance to Sun Pharmaceuticals’ Halol unit is mandatory for company’s future revenue growth as the US constitute almost 50 percent of the drug maker’s revenue. Last month, the FDA issued Form 483 with seven observations to Sun Pharmaceutical’s formulation plant situated at Mohali Punjab, which originally belongs to Ranbaxy Laboratories Limited, which further Sun pharmaceuticals has acquired by paying $ 4 billion in the year 2015. This is not the end of Sun Pharma’s problems they are also battling with the regulatory issues at its Karkhadi unit and Ranbaxy’s competency at Mohali, Dewas, Paonta Sahib and Toansa.