I am sensing great amount of euphoria around Natco on different forums including our very own VP, more so due to some big opportunity just round the corner (literally).
However, to me, a true balanced view comes from KNOWING, ACKNOWLEDGING and FACTORING-IN (use of caps is intentional) risks – evident or latent – to the story.
In this entire story, FDA compliance is one of the variable that is a REAL RISK. No matter how good the prospect may be from launch pipeline perspective however negative FDA observation can spoil the party big time. Its as severe as a death blow.
Looking at the industry landscape, most of the pharma majors are facing the wrath of stringent scrutiny from FDA. Take the examples of Sun pharma, (just for example purpose, it may have few others things going on as well), visionary leader, best in class execution and envious launches in its own segment however post FDA issues it never came back to its glorious past. Still struggling. Another example, IPCA, been 2.5 years and no respite in sight.
Request all to go through the attached Jan17 EIR report.
FDA EIR_Natco Pharma, Kothur, India.pdf (949.9 KB)
Observation #1 and #2 are procedural in nature.. From pharmacovigilacne and clinical data management perspective the incident and complain investigation are critical and adherence to procedures has to be established sufficiently.
For Natco, situation can become tricky as well since they dont have a back-up facility at this moment. Kothur facility is the only plant catering to US formation and this went through two successive inspection within short 6 months duration (Aug '16 and Jan'17). Vizag plant is also meant for US market however commencement and regulatory clearance are still away.
This is meant just to be cognizant of the latent risk embedded with the underlying story.