Cipla To Begin US Supplies From China Facility

Pharma major Cipla is set to commence supply operations to the US market from its China facility in the latter half of the current fiscal year, following approval from the US Food and Drug Administration (USFDA). 

Managing Director and Global CEO Umang Vohra noted this in the company’s Annual Report for 2023-24 and also detailed efforts to resolve regulatory issues at various domestic plants.

The China facility recently cleared the USFDA audit, positioning Cipla to initiate US supplies by the second half of FY 2024-25. Vohra provided updates on other facilities, noting that the Patalganga and Kurkumbh plants in India received Voluntary Action Indicated (VAI) status, indicating compliance. However, the Goa site faced certain observations, and the Indore plant is currently undergoing remediation. 

Addressing these regulatory challenges remains a top priority for the company, which has developed a comprehensive blueprint for expansion in India and is working closely with the USFDA to remediate these sites.

In addition to regulatory updates, Vohra outlined Cipla’s strategic focus on new therapeutic areas, including obesity-related diseases and liver conditions, supported by significant investments in tech-based solutions. The company aims to bolster its capabilities and continue its stewardship activities to combat the global threat of antimicrobial resistance (AMR). Cipla is enhancing its efforts in lung leadership, AMR and wellness while exploring therapies for obesity-related diseases, mental health and oncology.

Further, Cipla plans to introduce the novel Plazomicin injection in India as part of its robust antimicrobial portfolio. The company is also heavily investing in advanced technologies such as CAR-T cell therapy, peptides, oligonucleotides and biosimilars, which are expected to make a substantial impact in the future.