Sun Pharma’s travails with US regulator may drag on

The USFDA noted that Sun Pharma was “deficient regarding operations related to aseptic processing of drugs, its procedures for cleaning and maintenance failed to include sufficient detail of the methods of disassembling and reassembling equipment and there are lack of procedures to describe sampling, testing and approval and rejection of drug product containers”.

Although the USFDA did not find any data integrity violations, analysts said that one of the observations will require the company to redesign civil work inside the plant.

“We believe the observation will require minimum 3-6 months to redesign the filing lines (approved by FDA) followed by civil works, which could facilitate efficient aseptic practices including process of cleaning vials and lack of possibility for air-flow contamination,” said Surjit Pal, analyst with Prabhudas Lilladher. He added that the whole process may lead to shut down (at least partially) of filing lines of the current production of injectable and impact revenues of US exports of injectable products.