Set up 2 new GLP-compliant labs equipped with the best-in-class automation (pilot batch-making facilities) that ensure complete data integrity.
Promoted a 60:40 JV (Aleor Dermaceuticals Limited) with Orbicular Pharmaceutical Technologies.
This alliance increased the dermatology pipeline to 45 molecules, 4 of which they hope to file during FY18.
For Alero, they are setting up a greenfield manufacturing facility for dermatology products in Karakhadi which should go on stream by the H2FY18: US$ 4.7 billion market.
Commissioned a new API block to double the capacity.
US front end: Crossed US$50 million in revenues in only the first full year of operations in the US.
Transferred 18 products from their partners to their front-end and added two new products. In 2017- 18, they hope to transfer two products from their partners to their own label and add about 10 new products.
The difference between niche and commodity is declining faster than ever, leading to profit margins for conventional products getting squeezed. Two, each player is increasing the complexity play – increasing the pipeline of complex products that mandate a firm grasp on multi-step, challenging chemistries. This necessitates large investments by corporates in widening their capabilities and growing their intellectual capital bases.
Partnered with leading research outfits to intensify our R&D. The result: ~25% of our research programs are carried out in collaboration with partners.
Indian formulations business was impacted again by multiple price cut announcements and the FDC ban by the Indian regulatory authorities.
Stagnant performance continues
NPPA: The ban on 344 fixed dosage combinations included their 3 large brands (cold and cough). We were among the first few companies to get a stay on this ban.
Other developed markets are merely good for business presentations; no such revenue scaleup.
all of their facilities – API units (at Panelav and Karkhadi) and oral solid dosage (OSD) facility (Panelav) – successfully cleared the USFDA audit
Big goals: we hope to file 100 ANDAs in the next three years (starting 2017-18) – a sizeable proportion of which would comprise challenging products (Para IV/FTF opportunities).
Is partially able to achieve this with an average run rate of 25+ in the upcoming years.