Last month, generic drug and API maker Mylan received a US Food and Drug Administration (FDA) warning letter citing a lack of protection against contamination across three of its Indian manufacturing facilities, two of which the firm acquired when it bought Agila from Strides Arcolab in 2013.
Speaking at the Morgan Stanley Global Healthcare Conference in New York last week, CEO Heather Bresch said the firm is on-track with its remediation plan to bring the ex-Agila plants up to standard.
“As we inherit facilities, as we do acquisitions, we take the time that we need to invest to bring those standards up,” she told investors.
“In some cases just the yardstick changes, FDA changes kind of their thinking or philosophy about what they wanted standard to move to,” she continued. “So obviously we are in constant dialogue as changes are happening or as standards are improving, to make sure that we are doing everything we can to meet them if not exceed them.”
Despite the regulatory setback, she said the injectables business was a huge growth driver and Mylan is on the way to “really be a leader in the space.”
Supply Chain Stability
She told investors there has been growing demand from Mylan’s customers for a reliable, high quality global supply chain
“As we continue to live through the FDA transformation as far as inspection and facilities, the need for quality reliable supply chain has probably never been higher,” she said.
“So because of that - and as consolidation continues both on our customers side as well [as us] - they need more volume and more certainty and reliability around this volume.”
This has helped drive Mylan’s M&A strategy, she continued, as its growing portfolio reassures supply chain stability among its customers.
“When you take because of the breadth of our portfolio, we are able to really kind of manage the entire portfolio and not just the one off by our customers. That again helps bring that stability because of the supply we are able to reliably give and the quality around the portfolio of product that we are offering.”