Shilpa Pharma Lifesciences Unit-1 Passes Brazilian ANVISA GMP Inspection with No Critical Findings

Key Insights

• Shilpa Pharma Lifesciences Limited, Unit-1 successfully completed a GMP inspection by Brazilian regulatory authority ANVISA from June 30-July 4, 2025, with no critical or major observations.
• The facility received only procedural-related observations and recommendations, to which Shilpa is committed to respond through an appropriate CAPA plan within stipulated timelines.
• This regulatory milestone follows the facility's recent VAI classification from the USFDA in May 2025, demonstrating consistent compliance across multiple international regulatory jurisdictions.

Shilpa Pharma Lifesciences Limited, Unit-1, a wholly-owned subsidiary of Shilpa Medicare Limited, has successfully completed a Good Manufacturing Practice (GMP) inspection conducted by Brazil's National Health Surveillance Agency (ANVISA). The audit, carried out between June 30-July 4, 2025, concluded with no critical and no major observations, marking a significant regulatory achievement for the pharmaceutical manufacturer.

Inspection Results and Regulatory Compliance

The ANVISA inspection identified only minor procedural-related observations and recommendations, which the company characterized as non-critical findings. According to Shilpa's BSE filing, the company is committed to responding to the regulatory agency through an appropriate Corrective and Preventive Action (CAPA) plan addressing the procedural points within the stipulated timelines.

This successful Brazilian inspection follows another recent regulatory milestone for the same facility. In May 2025, Unit-1 received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) and was classified as Voluntary Action Indicated (VAI). The VAI classification indicates that while objectionable conditions or practices were found, the FDA is not prepared to take or recommend any administrative or regulatory action.

Company Profile and Manufacturing Capabilities

Shilpa operates as an integrated pharmaceutical group with diversified business interests spanning multiple therapeutic areas and manufacturing technologies. The company's portfolio encompasses niche oncology and non-oncology active pharmaceutical ingredients (APIs), peptides, polymers, and differentiated finished dosage formulations. Their specialized manufacturing capabilities include novel injectables, orally dispersible films, and transdermal patches, complemented by a carefully crafted biological portfolio.

The company provides comprehensive contract development and manufacturing organization (CDMO) services to global pharmaceutical companies across all its business segments. These services are supported by extensive research and development capabilities, backed by four R&D units and seven manufacturing facilities.

Market Response

Following the announcement of the successful ANVISA inspection, shares of Shilpa Medicare Limited traded at Rs. 887.75 on the BSE, compared to the previous close of Rs. 876.95. The stock experienced an intraday high of Rs. 896.00 and an intraday low of Rs. 866.50, with 2,697 shares traded across 217 transactions, generating a net turnover of Rs. 2,381,943.