White Paper

Pediatric Dosage Forms: Reformulation And Development Expertise And To-Scale Manufacturing

Source: Cambrex

Rising demand for pediatric dosage forms requires reformulation and development expertise but also to-scale manufacturing capabilities

Pharmaceutical companies are looking to pediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. The desire to develop pediatric dosage forms (PDFs) of drugs with existing adult indications has two main drivers: (1) the US Food and Drug Administration’s (FDA’s) role in limiting off-label use in pediatric patients, which aligns with the FDA’s role in ensuring the safety and efficacy of approved products for all patients; and (2) sustaining revenue growth through pediatric exclusivity that typically adds 180 days of intellectual property protection and thus almost 6 additional months of branded drug sales, which in some cases could translate to billions of dollars in revenue.

Cambrex’s infrastructure and expertise cover the sweet spot for producing the small-to-medium-sized batches needed to meet industry demands for PDFs and Orphan Drugs, and also extend to large-scale manufacturing.


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