Caplin Point Laboratories said it has received an Establishment Inspection Report (EIR) from the US FDA for a recently concluded inspection at the manufacturing plan run by its unit Caplin Steriles Limited.
“This was the third successful US FDA audit at the plant since 2016,” the company said, referring to the June inspection.
An EIR means that the company can continue to export products manufactured at its India plant to the US. In case inspectors find anything amiss in their checks, they usually issue a Form 483 noting the discrepancies. If everything goes well, they issue an EIR.
“We’re glad to receive the EIR within a short period of completing the inspection.. We’re also starting to see traction in terms of product approvals and commercial batches being rolled out of this facility,” said CC Paarthipan, Chairman of Caplin Point Laboratories Limited.
Caplin Point Laboratories Limited is a fast-growing pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa.
It operates in regulated markets such as US through Steriles Limited, Caplin.
Caplin Point Labs has three manufacturing locations: Pondicherry, which focuses on tablets, capsules, granules, liquid orals, ointments and creams; Baddi, which specializes in tablets, capsules, granules, liquids orals, ointments and creams; and Chennai, which is home to its sterile manufacturing facility for regulated markets like USA, Europe, Brazil, Russia, South Africa & Australia.
The company recently expanded its Pondicherry plant to produce suppositories, soft gelatin capsules and penems.
The company also has an R&D Centre in Chennai.