Cipla, a global pharmaceutical company, has received Voluntary Action Indicated (VAI) status from the United States Food and Drug Administration (USFDA) for two of its manufacturing facilities in India, marking positive regulatory outcomes for the company.
Goa API Facility Receives VAI Classification
The USFDA conducted an inspection of Cipla's Medispray facility in Goa from January 14 to 20, 2025. The inspection concluded with the issuance of one observation in Form 483. In an email communication dated April 11, 2025, which Cipla received on April 17, 2025, the USFDA confirmed the VAI classification for the facility.
The VAI status indicates that while the agency found violations, they are not significant enough to warrant regulatory action. This classification allows the facility to continue operations while addressing the issues identified during the inspection.
Sitec Labs' Mahape Facility Also Secures VAI Status
In a separate development, Cipla announced that its wholly-owned subsidiary, Sitec Labs Limited, has also received VAI status for its analytical testing facility located in Mahape, Navi Mumbai. The USFDA conducted a current Good Manufacturing Practices (cGMP) inspection at this facility from February 18 to 20, 2025, which initially resulted in two observations in Form 483.
The USFDA communicated the VAI classification via email on May 16, 2025, as disclosed by Cipla in a BSE filing. This classification for the Mahape facility similarly allows operations to continue while the company implements corrective actions for the identified issues.
Understanding FDA Form 483 and VAI Classification
An FDA Form 483 is issued to company management at the conclusion of an inspection when investigators observe conditions that may constitute violations of the Food, Drug, and Cosmetic Act and related regulations. The observations require attention but do not necessarily indicate serious compliance issues.
The VAI (Voluntary Action Indicated) classification is one of three possible outcomes from an FDA inspection, sitting between NAI (No Action Indicated) and OAI (Official Action Indicated). With a VAI status, the FDA has found objectionable conditions but does not consider them serious enough to warrant regulatory action, allowing the company to address the issues voluntarily.
Cipla's Market Position and Performance
Established in 1935, Cipla has grown into a major global pharmaceutical player focused on sustainable growth, complex generics, and deepening its portfolio in key markets including India, South Africa, North America, and other regulated and emerging markets.
The company operates 47 manufacturing sites worldwide, producing over 50 dosage forms and 1,500+ products that serve more than 80 markets globally. Cipla has particular strengths in respiratory, anti-retroviral, urology, cardiology, anti-infective, and CNS segments.
In its financial performance, Cipla reported strong results in Q3 FY25, with consolidated net profit jumping 48.73% to Rs 1,570.51 crore compared to Rs 1,055.90 crore in Q3 FY24. Total revenue from operations grew by 7.10% year-on-year to Rs 7,072.97 crore in the quarter ended December 31, 2024.
Regulatory Compliance and Future Outlook
The VAI classifications for both facilities represent positive outcomes for Cipla, as they allow the company to continue manufacturing operations while addressing the minor compliance issues identified by regulators. These developments are significant for Cipla's ongoing operations and its ability to maintain supply to the US market, one of its key revenue generators.
For pharmaceutical companies, maintaining good standing with regulatory authorities like the USFDA is crucial for ensuring uninterrupted business operations and preserving market confidence. The relatively minor nature of the observations at both facilities suggests that Cipla's manufacturing quality systems are largely effective, requiring only targeted improvements rather than major overhauls.
