Last week the Indian drug and active pharmaceutical ingredient (API) firm said it will start supplying generic medicines to French hospitals in March. The initial focus will be cancer drugs and anti-infectives.
A Dr. Reddy’s spokesperson told us “we have been connected to the French market historically through API supply and we work closely with the leading players in the French generics market” adding that “France is where we opened our first EU API office.”
The move follows a few months after Dr. Reddy’s entered the Italian and Spanish hospital markets and is part of European expansion plan according to the spokesperson.
“We have a wide portfolio of products catered to this strategy and our diverse portfolio of complex generics is specialized for the use in hospital market. The French hospital market is more than €6bn [$6.3bn], making it one of the largest markets in EU.”
Dr. Reddy’s told us the drugs sold in France will be manufactured either at its sites in India or by European partners.
“Through the combination of in-house and our partner network, we have sufficient and flexible capacity to reliably supply these markets. However, depending on the market demands, the company will consider investing to expand internal capacity in addition to working with good quality reliable third party manufacturers.”
The spokesperson added that: “We will also use our internal finished dosage packaging facility located in Beverley, Yorkshire, UK. The final quality control and release will be handled exclusively from Europe.”
Quality control has been an issue for Dr. Reddy’s over the past few years. Last year the firm said warnings it received from the US Food and Drug Administration (FDA) had significantly impacted its earnings.
The firm told us it has implemented substantial remediation work at the plants criticized by the US regulator and its other manufacturing facilities, including those which will supply France and other European markets.
“Our application of Corrective and Preventive Actions or CAPAs were not just site specific but they were also network wide and incorporated third-party review and assessments. In the process of implementing the CAPAs, we have made significant progress in enhancing our quality systems and instilling the culture of quality and continuous improvement.”
The spokesperson added: “We ensure that our products comply with the local statutory and regulatory requirements across the countries that have our marketing presence.”