India’s generic-drug dominance is being squeezed as the US and Europe push for newer, tougher-to-manufacture molecules under stricter FDA compliance. Instead of building plants, Hyderabad-based HRV Pharma is banking on “drug visas,” or FDA DMFs that act as regulatory licenses for exporting active ingredients. The company, which owns no factories, operates in 55 countries and holds 66 DMFs, charging other manufacturers for the regulatory work—turning compliance into a scalable asset.
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