When US Food and Drug Administration (FDA) inspectors arrived unannounced at Hetero Labs’ warehouse facility in Visakhapatnam, India, on 19 September , they documented conditions that would result in a scathing six-observation Form 483: birds flying through storage areas, lizards crawling between active pharmaceutical ingredient (API) drums, inadequate environmental controls, and compromised storage of active pharmaceutical ingredients destined for US-registered facilities.
This recent instance is not a rare exception. The FDA conducts nearly 15,000 inspections annual. In 2024, they issued nearly 1,800 citations from 443 inspections for drug and biologics alone. The most significant impact of these citations may have nothing to do with the violations themselves, but the opportunities they present to the broader industry.
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For contract manufacturers capable of absorbing API production, equipment suppliers who could support facility remediation, and service providers offering compliance solutions, access to real-time and proprietary signals is the game changer setting apart the leaders.
The supply chain ripple effect
The opportunity and ripple effects can be demonstrated using this recent example with Hetero Labs. According to GlobalData’s proprietary data, the affected facility manufactures APIs for two critical drugs supplied to pharmaceutical giants Pfizer and Novartis. This facility engages in the API manufacturing of nirmatrelvir for Pfizer’s Covid-19 treatment, Paxlovid, and diclofenac sodium for Novartis’s anti-inflammatory drug, Voltaren.
While both companies maintain diversified supply chains for these products, the inspection creates immediate opportunities across the pharmaceutical supplier ecosystem—if stakeholders can identify them quickly enough.
Pfizer’s Paxlovid supply chain illustrates the complexity of modern pharmaceutical manufacturing. The company produces nirmatrelvir API at its own facility in Ireland while also sourcing from external manufacturers including Esteve, AbbVie, Axplora, and WuXi AppTec, in addition to Hetero. When one supplier faces regulatory challenges, pharmaceutical companies must rapidly assess alternative capacity and potentially accelerate relationships with secondary sources.
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By GlobalDataSimilarly, based on information compiled by GlobalData, Novartis manufactures diclofenac sodium for Voltaren at facilities in the UK and Switzerland, supplementing internal production with external suppliers including Hetero. This diversification provides some buffer against supply disruptions, but regulatory events still trigger urgent supply chain reviews and vendor qualification processes.
These situations present multiple strategic opportunities. The immediate need is capacity replacement—pharmaceutical companies facing potential supply constraints must identify alternative manufacturers who can meet quality standards and regulatory requirements. GlobalData research shows that contract manufacturing organisations (CMOs) who engage within days of a regulatory event, rather than weeks, capture a disproportionate share of redirected business.
Beyond capacity needs, regulatory events like these create longer-term competitive intelligence advantages. CMOs with knowledge of their competitors’ compliance history can differentiate proposals by emphasising facility standards, inspection track records, and quality system maturity. In an industry where reputation and reliability drive purchasing decisions, these insights prove invaluable.
The opportunities extend beyond manufacturing. Suppliers of environmental monitoring systems, laboratory equipment, and validation services find urgent demand during facility remediation efforts. Quality consultants and compliance service providers become strategic partners as organisations work to address Form 483 observations and prevent recurrence. Even logistics and packaging providers may see opportunities as pharmaceutical companies redirect supply chains or establish new distribution pathways.
Regulatory changes impact on international opportunity flow
These opportunities are expected to grow. In May 2025, the FDA announced the expansion of unannounced inspections at international facilities. This comes after years of US facilities being subject to frequent, unannounced FDA inspections while giving at least a week’s notice to sites internationally.
“Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections,” a statement from the FDA commissioner noted. The higher deficiency rate at international facilities with advanced notice leads us to expect a growing number of citations while the FDA continues to review policies and operations in an attempt to hold international facilities to the same standard as US sites.
The real-time intelligence advantage
Leading pharmaceutical CMOs and suppliers increasingly recognise that success depends not just on capabilities, but on the speed and quality of market intelligence. The most successful organisations rely on real-time insights. Just as CROs use GlobalData’s Sales Intelligence solution to understand future clinical trial opportunities, now CMOs, equipment suppliers and consultants are using these critical data-driven that have been newly added into the Sales Intelligence solution.
Life science suppliers need insights beyond simple regulatory and clinical events. GlobalData’s proprietary buying signals and supply chain mapping links facilities to drug companies and products, providing a sophisticated level of intelligence needed to optimise sales operations. When an inspection occurs, suppliers can immediately understand which products are affected, which pharmaceutical companies may need alternatives, and what specific technical capabilities would be required to serve as a replacement manufacturer. For example, a CMO specialising in antibody development can receive alerts tailored to its expertise, which would be distinct for one that focuses on small molecule API manufacturing.
The question facing pharmaceutical supply chain organisations is no longer whether to invest in advanced intelligence capabilities, but rather how quickly they can deploy systems that turn regulatory events into captured business opportunities.
Amanda Murphy is the Senior Director of Digital Product Management at GlobalData. To learn how GlobalData’s Sales Intelligence solution can help you capitalise on market opportunities and to book a demo, click here.
