Gland Pharma has announced that the United States Food and Drug Administration (US FDA) conducted a routine Good Manufacturing Practice (GMP) inspection at its VSEZ sterile oncology formulations facility and API facility in Visakhapatnam, Andhra Pradesh.

The inspection was conducted between August 24 and September 1, 2026, and concluded with zero Form 483 observations, according to the company.

A Form 483 is issued by the US FDA when inspectors identify conditions or practices that may represent violations of regulatory requirements. The absence of observations indicates that no such issues were cited during the inspection.

Gland Pharma operates across sterile injectables, oncology and ophthalmic segments, with a focus on complex injectable products. Its portfolio includes NCE-1s, First-to-File products and 505(b)(2) filings.

The company primarily follows a Business-to-Business (B2B) model and has established capabilities across pharmaceutical research and development, manufacturing and marketing of complex injectable products.

The latest inspection outcome further supports Gland Pharma’s focus on maintaining regulatory compliance and manufacturing standards across its facilities serving global pharmaceutical markets.