Granules to expand Indian API plants and US dosage form site

By Gareth Macdonald

- Last updated on GMT


Related tags Pharmacology

Granules India will build an API production facility in Bonthapally, Telangana and expand other manufacturing sites in a project backed by the Word Bank. 

The Indian drug firm confirmed the plan last night, telling us it will use the $47.5m (€44.9m) World Bank grant to build the Bonthapally active pharmaceutical ingredient (API) plant and up capacity at its ingredient facility in Visakhapatnam (Vizag).

Granules will also increase capacity at a plant in Gagillapur where it produces pharmaceutical formulation intermediates (PFIs).

A spokesman for the firm told us “existing capacities are not sufficient to meet customer demand​” adding the new and expanded facilities will supply both local and international markets.

He also confirmed the expansions will create jobs.

US dosage form site expansion

Granules also confirmed that it plans to add manufacturing capacity at its finished dosage facility in Chantilly, Virginia in the US. However, the firm told us the World Bank grant will not fund the project.

The spokesman said: “Investment in finished dosage facility at Chantilly, Virginia is being funded through internal accruals and funds brought in promoters​.”

Vizag site

News of the plan to invest at Vizag follows just a few months after the facility was inspected by the US Food and Drug Administration (FDA).

The visit - confirmed by Granules in a Bombay Stock Exchange (BSE) filing in December - saw the US agency raise seven (7) observations,​” details of which were not provided. 

At the time Granules' head of investor relations, Sumanta Bajpayee, was upbeat, telling us “This the first inspection for the site and we believe it is positive step towards getting the site approval."

He added: “Teams have already acted upon some of these observations and will send the response to the FDA within stipulated time period. We cannot disclose the observations till we submit our response to the FDA."

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