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PeptiNova is not a compounding pharmacy or chemical compounding facility as defined under 503A of the Federal Food, Drug, and Cosmetic act

these are FDA-registered outsourcing facilities held to cGMP manufacturing standards, a higher bar than standard 503A compounding pharmacies

according to the latest meta-analysis including over 11 million patients, the rate for the world population is 1 : 313, but in patients with ischaemic heart disease the incidence is 10 times higher (1 : 31), with premature ischaemic heart disease 20 times (1 : 15), and in those with severe hypercholesterolaemia, 23 times higher (1 : 14) [276]

Shakeri A, Tabibi H, Hedayati M

What are the main challenges companies face when trying to improve efficacy or safety in this competitive class

In other cases, switching to a different medication might be the best option