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The company has formed a Pediatric Center of Excellence in support of the development and manufacture of dosage forms for pediatric indications.
On May 10, 2017, Halo Pharma announced the formation of its Pediatric Center of Excellence in support of the development and manufacture of dosage forms tailored for pediatric indications. Halo Pharma has been working closely with pharmaceutical companies to overcome the challenges in developing pediatric dosage forms (PDFs) of already approved adult dosage forms.
In support of its Pediatric Center of Excellence, Halo Pharma has developed the infrastructure, process trains, and equipment needed for efficient, cost-effective, and rapid production of small- to medium-scale cGMP clinical drug products that are used in pediatric clinical studies. Halo Pharma has partnered with several pharmaceutical companies to develop commercially viable PDFs that have received both US and international regulatory approvals.
The company currently has multiple clinical and commercial PDF programs underway. In nearly all cases, developing a PDF from an adult dosage form requires additional product development work. In many cases, it is necessary to provide the PDF in various strengths matched to different pediatric age/weight brackets. Halo Pharma has the capability to manufacture batches of PDFs that typically range in scale from 5 kg to 1000 kg.
Halo Pharma will be exhibiting at the CPhI North America conference in Philadelphia PA, from May 16–18, 2017.
Source: Halo Pharma