â€œThe third party consultants are regularly visiting our manufacturing units which are under USFDA import alert/warning letter and are assisting us in implementing robust remediation measures in a proper and timely manner,â€ Ipca said in a clarification to stock exchanges.
Drug maker Ipca Laboratories on Wednesday said it has completed remediation work at two of its formulation plants in Pithampur and Piparia that were banned from exporting drugs to United States market.
In an interview to CNBC-TV18, the company’s management said both its Pithampur, Madhya Pradesh, and Piparia (Silvassa, Dadra and Nagar Haveli) formulation plants are undergoing verification by third party consultants, which is expected to be completed by March 2017.
Ipca said remediation at Ratlam, Madhya Pradesh active pharmaceutical ingredient plant is expected to be completed by the end of first quarter FY18.
“The third party consultants are regularly visiting our manufacturing units which are under USFDA import alert/warning letter and are assisting us in implementing robust remediation measures in a proper and timely manner,” Ipca said in a clarification to stock exchanges.
On January 29, last year the USFDA issued a warning letter outlining manufacturing quality lapses observed at three of its facilities at Ratlam, Pithampur and Piparia.
The plants have already been banned from supplying to the US after the drug regulator inspected them in July 2014, January 2015 and March 2015, and first highlighted the lapses.
Ipca said it has since been trying to fix the problems and has been informing FDA of its remedial measures.
The regulatory issues hit company's revenues with exports falling about a 25% to Rs.922 crore in FY16. The company’s institutional business that contributes about 4% of the revenues lost contract to supply anti-malarial artemisinin-based combination therapy with Geneva-based Global Fund in April last year decided against allocating business to the company based on USFDA action.
Shares of Ipca rose 4.14 percent and were trading at Rs.556.40 on BSE at 1 pm, the benchmark Sensex gained 0.70% to 27,092.17 points.