RPM Cybersecurity 2026: FDA 524B Mandates & SBOM Compliance

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The RPM Cybersecurity Shift: Navigating New FDA Mandates and Software Supply Chain Transparency in 2026 A Senior Cybersecurity Architect's Field Guide — Because "We Think We're Covered" Is No Longer Good Enough May 2026  |  20-minute read  |  Written for C-Suite, Regulatory Affairs, and QA Leadership 📋 Table of Contents The Confidence Paradox: Why 90% Confidence Masks a 50% Coverage Gap The FDA Mandate Reality: Section 524B Is Not a Suggestion Anymore RPM Cybersecurity 2026: How CMS Expansion Created a New Attack Surface SBOM in 2026: From Compliance PDF to Quality System Backbone Comparison Table: Pre-2026 vs. The 2026 Mandatory Framework ISO 14971 as Connective Tissue: Risk Management Meets the Supply Chain Real-World Scenario: How a Mature SBOM Prevented a Class I Recall FDA Inspection Readiness: What Investigators Will Look For Under CP 7382.850 What You Need to Do Right Now: A 7-Poin...
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Alembic seeks to mix it with US and European players

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Alembic seeks to mix it with US and European players


Indian pharmaceutical firm Alembic is seeking to expand its presence in the lucrative US and European drug markets through an expanded partnering programme. 

The Gujarat-headquartered group, which is involved in both the active pharmaceutical ingredient (API) and pharmaceutical formulation markets, aims to grow internationally and double its annual turnover over the next two to three years, according to a report in India’s Business Standard.

Company director Pranav Amin explained that the firm intends to file about 10-12 ANDAs every year and to tap potential in the generic markets of the US and Europe. 

The company has also submitted around 22 drug master file (DMF) requests to regulatory agencies in Europe and the US in recent years in a bid to boost its roster of API clients.

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