Manufacturing woes in India continue in the spotlight, though Sun Pharmaceutical says it will focus on one plant at a time to restore the fortunes of four Ranbaxy manufacturing units banned by the U.S. FDA.
But Wockhardt may be in for some heat as the FDA said the blood pressure drug Captopril and antibiotic Clarithromycin tablets recalled for what the company said was a precautionary move actually were yanked for deviation in good manufacturing practices.
All of this comes as India's plans to boost domestic drug manufacturing and cut reliance on imports from China by offering a 15-year tax holiday, low-cost space at industrial parks and subsidies on interest owed to banks, according to Bloomberg TV India.
In the case of Sun, the main issue is to "re-establish" trust between Ranbaxy and FDA, according to a report on the NDTV Profit website, citing a call the head of the company had with analysts.
|Sun Pharma Managing Director Dilip Shanghvi|
"Clearly, we will focus our energies on one plant with a view to bring it back to compliance rather than focusing on all the plants in which the whole process would get significantly delayed," Sun Pharma Managing Director Dilip Shanghvi said in an analyst call.
Ranbaxy's units Mohali and Toansa in Punjab, Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh are currently barred from exporting drugs to the U.S.
Shanghvi, NDTV Profit said citing a FDA notice, also told the analysts that Sun has taken steps to fix its own FDA-licensed facility at Halol in Gujarat.
In the case of Wockhardt, DNA India said the FDA initiated the recall on May 22.
Wockhardt Chairman Habil Khorakiwala said in April that the company had voluntarily withdrawn 12 to 15 drugs from the U.S. manufactured at its two facilities in Aurangabad, Chikalthana and Waluj.
Special Report: The 25 most influential people in biopharma in 2015 - Dilip Shanghvi - Sun Pharmaceutical