Gland Pharma Ltd has received a GMP compliance certificate from the Danish Medicines Agency for Suite 5 of its Pashamylaram Unit II facility in Hyderabad, following a detailed inspection on November 20, 2023. This certification adds to a string of global regulatory approvals, including a recent US FDA Establishment Inspection Report (EIR) received in January 2025.
Latest Certification Scope:
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Covers aseptic manufacturing of smallvolume liquids via sterile filtration.
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Includes secondary packaging, microbiological sterility and nonsterility testing, and chemical/physical quality control.
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Applies strictly to Suite 5 operations; all other suites and lines are excluded.
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Warehousing and utility systems supporting Suite 5 are also certified.
Recent Regulatory Milestones:
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US FDA inspection (July 25–August 2, 2024) concluded with EIR issued on January 18, 2025, confirming GMP compliance.
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UK MHRA certificate also validates Suite 5 for similar operations under EU GMP norms.
Strategic Impact:
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Strengthens Gland’s sterile injectable export capabilities across Europe and the US.
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Enhances credibility for B2B partnerships and contract manufacturing in regulated markets.
Sources: Danish Medicines Agency, MHRA UK, US FDA EIR Filing, Business Standard, Moneycontrol.