USFDA Cites Aspen Biopharma for Major Manufacturing Lapses in Telangana

Aspen Biopharma Labs faces a critical warning from the USFDA for significant manufacturing deficiencies at its Telangana-based API facility. The concerns include inadequate building designs, lack of appropriate separation for hazardous materials, and insufficient stability testing protocols. Aspen's future in the US drug market remains uncertain.

The US Food and Drug Administration (USFDA) has issued a warning to Aspen Biopharma Labs, highlighting significant manufacturing deficiencies at its active pharmaceutical ingredients (API) production facility in Telangana.

Concerns include improper building design, lack of separation for hazardous materials, and the facility's overall state of disrepair.

The firm must now decide whether to cease production for the US market, while implementing corrective measures for future compliance.

(With inputs from agencies.)