Pfizer is ending manufacturing at two injectable manufacturing plants in India, one in Irungattukottai (IKKT) and another in Aurangabad, due to what the company says is a decline in demand for products manufactured at the plants. Pfizer had acquired the plants as part of its $17-billion acquisition of Hospira, a specialty pharmaceutical company of sterile injectable drugs and biosimilars, in 2015.

Pfizer said the plants will immediately cease manufacturing with the intention to exit both sites as soon as possible in 2019. ‘Pfizer has conducted a thorough evaluation of the IKKT and Aurangabad sites in India and concluded that due to the very significant long-term loss of product demand, manufacturing at these sites is not viable,” said a Pfizer spokesperson. “As a result, Pfizer has announced that both the Aurangabad and IKKT sites will immediately cease manufacturing with the intention to exit both sites as soon as possible in 2019. The exact timing of the exit of the sites is to be determined which will be dependent on applying for regulatory and legal applications and receipt of the necessary approvals in this regards.”

Approximately 1,700 people are employed at the plants. The IKKT site has 1,000 employees, and the Aurangabad site employs approximately 700. “Pfizer is committed to conduct this process in a way that is transparent and fair towards all its colleagues and is keeping colleagues informed at every step,” said the Pfizer spokesperson.

The Pfizer spokesperson said that the IKKT and Aurangabad are purely export-oriented sites and do not supply products for Pfizer’s India commercial operations. “This announcement does not affect our other Indian manufacturing sites in Goa, Vishakapatnam (Vizag) and our joint venture site, ZHOPL, in Ahmedabad,” said the spokesperson.

Pfizer operates five manufacturing sites in India. Pfizer is also announcing an expansion to its operations at the Vizag site in India. The Vizag site is being expanded into a global Terminally Sterilized Manufacturing Center of Excellence. “It will cater to export markets, such as United States and eventually we expect to Canada,” said the spokesperson.

The Irungattukottai site had reported previous manufacturing issues, including receiving a Warning Letter from the US Food and Drug Administration in 2013 for GMP violations of finished pharmaceuticals and a Form 483 in 2016 for several observations relating to manufacturing/quality issues at the plant.

Source: Pfizer