Granules predicts US and EMA approval for new API plant in two years

India’s Granules and Belgian fine chemicals firm Ajinomoto Omnichem partnered to set up the facility in Visakhapatnam, Andhra Pradesh in 2011​, touting the site as a production hub for low volume, high value active pharmaceutical ingredients (APIs) and intermediates.

The plant was inaugurated on Friday by Mr. M. Venkaiah Naidu, Hon’ble Union Minister for Urban Development, Housing and Urban Poverty Alleviation and Parliamentary Affairs and other members of the Indian Government.

Delay​

The facility cost $20m (€14m) to build and was due to be operational in 2013, but according to Granules India managing director Krishna Prasad Chigurupati the opening was put back in response to design changes requested by customers.

“We had initially planned to open the facility by 2013. However, we incorporated some design changes in the facility as recommended by our customers and therefore, consciously pushed the inaugural date to 2015​.”

Chigurupati told in-Pharmatechnologist.com that initially the plant “will supply its products to Ajinomoto OmniChem to cater to the requirements of the Ajinomoto OmniChem customers​.”

EU and US customers​

Once the facility has received the required regulatory approvals the plan is to supply other customers in European and the US directly according to Chigurupati, who added that the plant “will not supply any of its finished products to India.”​

He predicted these approvals will take two years to obtain, after which customer supply will begin.

He added that: “The sale of validation batches has already started, and we will continue to supply the intermediaries until we receive the US Food and Drug Administration and European approval for the site​.”