The inspection ended on August 25, 2018, and now leaves Strides Shashun, headquartered in India, needing to rectify the issues, though it will still be able to supply product from the facility.
The firm has already received approval from the US Food and Drug Administration (FDA) for the medicine that will be manufactured at on-site – potassium chlorine extended-release tablets. The issues at the Bangalore facility were identified as part of the FDA’s pre-approval product inspection.
The announcement to The National Stock Exchange of India did not specify what prompted the three observations noted by the FDA.
However, the company stated, “the observations are not material in nature and we have already responded to the US FDA.”
As a result of the announcement, the share price of Strides dipped from 500 rupees ($6.96) to 477 rupees, before rebounding to 490 rupees.
In response to a request for further detail on the observations, a spokesperson for Strides stated: "The company has already responded to the US FDA within the stipulated timelines. As a policy, we do not comment on specifics of observations unless we believe that there is a material impact."
Good news down under
Just two days announcing the Form 483, Strides released positive news on the clearance of a merger between Arrow Pharmaceuticals, a division of Strides, and Apotex Australia.
The deal had to be verified by the Australian Competition and Consumer Commission, which notified Strides today that it would have no opposition to the deal. The new company will provide generic medication to the Australian market.
It is not the first time that Strides has chosen to merge a smaller subsidiary with another company, it had previously done the same with its active pharmaceutical ingredient (API) unit in a transaction with Sequent. The newly-formed company is now known as Solara Active Pharma Sciences.