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Gland Pharma stated that the United States Food and Drug Administration (FDA) has conducted a routine Good Manufacturing Practice (GMP) inspection at the company’s VSEZ sterile oncology formulations facility and API facility at Visakhapatnam between August 24, 2026 and September 01, 2026.
The company said the inspection was concluded with ZERO (0) Form 483 observations.
The company is present in sterile injectables, oncology and ophthalmic segments, and focuses on complex injectables including NCE-1s, First-to-File products and 505(b)(2) filings. The company operates primarily under a business to business (B2B) model and has a track record in the pharmaceutical research and development, manufacturing and marketing of complex injectables.
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