Pharmaceuticals maker Caplin Point Laboratories said the US FDA has completed inspection of its Sterile Injectable manufacturing facility at Gummidipoondi in Chennai and issued two observations.
The good manufacturing process inspection was done between June 6th and 14th.
“The Company believes these to be of procedural in nature and the corrective and preventive actions for these observations will be presented to the US FDA shortly.
“The observations made were not repeat observations or related to data integrity,” the company said.
This was the third US FDA audit at the plant since 2016.
“Our primary focus is to ensure integrity and maintain transparency in our quality systems, and we’re pleased with the result of yet another successful audit,” said Mr CC Paarthipan, Chairman of Caplin Point Laboratories Limited.
Caplin Steriles Ltd, which operates the plant, is a wholly owned subsidiary of Caplin Point Laboratories Limited.
It is a niche sterile product manufacturing company that is approved by US FDA and EU-GMP.
The company has filed 11 generic applications so far, with 4 approvals.
It said it has a pipeline of 40+ ANDAs that it intends to file over the next 5 years.
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 is present in regulated markets such as US through Caplin Steriles Limited.