SSPL is a leading manufacturer of rare drugs especially those which are effective in orphan diseases. Working in the field of IC/BPS, SSPL has given pentosan polysuphate to many parts of the globe.
Here are some salient points about SSPL which make it Unique:
1) Pentosan Polysulfate Sodium (USDMF No. 25827 & Written confirmation available)
2) We are the largest commercial manufacturers of Pentosan globally, with an installed capacity of 18 MT, scalable to 24 MT.
3) We are backward integrated with manufacturing the key raw material from Beechwood
4) We have been approved as PPS suppliers by Ivax (TEVA) who own the rights to the oral dosage formulation (Elmiron). We have launched our brands for Pentosan in India and Korea and are in process of launching them in countries all over the world.
5) We have launched the product in India for veterinary equine usage, and hence can supply material with microbiological control.
6) We have 10 global scientists who are working on different aspects of the molecule, including process chemistry, analytical chemistry and clinical studies, which gives us an edge in scientific backup available.
7) Sun Pharma has tied up with us for co-marketing the drug in India under brand Cystopen( pentosan capsules).
8) In addition we have conducted pre-clinical studies on animal model at the prestigious Mount Sinai School of Medicine, New York to prove equivalence between Elmiron and Comfora, and have also been approved as suppliers to the innovators (IVAX/TEVA).
9) We are conducting research with prestigious universities across the world for use of Pentosan in new indications
10) We have 10 global scientists who are working on different aspects of the molecule, including process chemistry, analytical chemistry and clinical studies, which gives us an edge in scientific backup available.
11) We are in contact with more than 2500 urologists in India, and Comfora is being sold regularly through more than 500 urologists all across India.
12) Top class clinicians in the US with more than 20 years of experience, including Dr. David Kaufman, on treating IC are on our advisory board.
14) The few important proof of why we are global leaders and authority on the subject are the US FDA approval for our API site, our progress with US FDA on the subject of characterization, our patients benefiting in India and several countries where we export for over 6 years now.