The inspection – reported in a Shasun filing on the Bombay Stock Exchange (BSE) this week – focused on the site’s 9,290 sqm drug formulation operations, which house granulation, coating, tableting and packaging techs used for the production of pills and capsules.
In addition to being the base for Shasun’s formulation business, the site is also home to its active pharmaceutical ingredient (API) operation – which is focused around ibuprofen, lysinate and sodium salt production – and its newer biotechnology unit.
In the filing Shasun refers to the inspection by the UK-based Medicines and Healthcare products regulatory Agency (MHRA) visit as a ‘EU inspection.'
In the UK Shasun operates a manufacturing facility in Cramlington, Northumberland - which produces APIs and intermediates. The firm also provided custom synthesis and manufacturing services at a facility in Annan, Scotland, however this ‘underused’ site was shut down in 2009.
The MHRA assessment follows shortly after visits by the US Food and Drug Administration (FDA) – which carried out a post-approval review in June – and Brazil’s National Health and Surveillance Agency (ANVISA), which undertook a pre-approval inspection in July.
Clearly, the Puducherry facility is an important site for Shasun. Further evidence for this came last month when the firm announced its earnings for the fiscal first quarter ended June 30.
Net revenue for the period declined 13.5 per cent to INR2.16bn ($31) with Shasun sliding into a net loss of INR65.7m from profit of INR138m in the comparable period last year.
The end of the period coincided with industrial action at the Puducherry site, which halted manufacturing operations for 13 days.
In BSE filing on June 28 Shasun reported that the strike had been resolved and that an “amicable settlement has been reached with the workers.”
The firm did not say how much the industrial action had cost, however reports in the Indian media bout a 15-day strike at the plant that took place in 2011 suggested that Shasun had impacted the firm’s top line to the tune of INR50m.
Shasun did not respond to request for comment ahead of publication.