Stellence Pharmscience Pvt Ltd. 456, Road #3, Industrial Area, Jigani, Bangalore South,

Transcription

1 Stellence Pharmscience Pvt Ltd 456, Road #3, Industrial Area, Jigani, Bangalore South,

2 Stellence Background Stellence Pharmscience Pvt Limited (SPPL) is promoted by Ramachandran Radhakrishnan (Ram) and Dr. Francis Pinto managers with extensive experience and proven track record in both Indian and International pharmaceutical industry The SPPL opportunity was established in 2006 through a cost effective purchase of assets and turnaround of a distressed company in BIFR (bankruptcy restructuring) The first phase of development, financed by the promoters, has been completed - SPPL currently operates a state of the art manufacturing and research facility in Bangalore The next phase of the project focuses on the cost effective development and manufacture of niche, high value pharmaceutical products and intermediates 2

3 Historical background and milestones To Commenced operations as Karnataka Chemsyn Ltd (KCL) to manufacture ibuprofen; Ibuprofen strategy unsuccessful; Diversifies into herbal extracts Turns sick and referred to BIFR; Avigna Chemitech, promoted by Mr. R. Ramachandran and Dr. Francis J. Pinto identifies strategic opportunity to acquire KCL; Negotiates with KCL per BIFR norms; Acquires KCL and commences operations in 2006; Avigna invests heavily in KCL; Builds state of the art manufacturing, process research and development facility; Emerges from BIFR; Conducts extensive development and testing to overcome technical barriers in manufacture of contrast media agents; KCL is renamed Stellence Pharmscience Private Limited; Establishes processes and growing product portfolio; Multiple orders with strong revenue growth; In 2012, received strategic interest from an experienced overseas company with strong credentials in Latam and emerging markets; Deal does not go through because of regulatory changes and delays; Poised to grow rapidly by taking advantage of huge opportunities in core areas of interest Contrast media products, niche APIs and contract manufacturing; Expanding new product portfolio; Raising capital for expansion of Contrast media manufacturing, scaling up APIs, further development of APIs, DMFs and retiring high cost debt; 3

4 SPPL Sales Strategy - Market Opportunity Niche High Value Specialty API (SAPI) - Overall Indian Pharma market ~ $11 billion, 20% CAGR. API market is ~$4Bn - Broad range of products in space - SPPL target niche, low volume high value products - SPPL focus on off radar, and complex manufacturing High End Intermediates (HEIN) Contrast Media Products (CMP) - Contract manufacturing of intermediaries for MNC - Opportunity market worth ~$3 billion - Leverage high quality facility, cost effective process - Utilise capacity - QC validated by International Partners - Diagnostic imaging agents - Global market worth over $5 billion - Complexity in manufacturing process (Quality) - Rapid growth in emerging markets - Market controlled by a few players: Bracco, Bayer - Opportunity to source Iodine from Latam directly 4

5 SWOT Analysis Strengths Very experienced promoter/directors in the area of pharmaceutical manufacturing Contrast Media market space with limited competition and pioneer advantage State of art manufacturing facilities for catering to regulated and other markets. Well equipped Quality Control systems and experienced Quality Assurance team Proven Process Research and Development capabilities India Strong relationship and network in Pharma sector for assured opportunities. Opportunity The size of the global market for Contrast Media is growing Great opportunity for generic API and intermediates exports Big Pharma and others looking for reliable manufacturers for their off patented products India offers high quality and cost competitive production facility for bulk drugs and intermediates Challenges Ensuring and maintaining relationship with partners integrity, IPR management etc. Ensuring cost and timely delivery especially as most are long term contracts. Retention of talent is critical factor. Margin pressures and changing government policies. Working Capital and financial needs Threats Spate of M&A activities by MNC Pharma may strain established relations Growing presence of MNCs in India in the Pharma sector as Capex is easier/affordable As result increase in competition and margins can come under pressure. Changing export and import policies Foreign exchange risk 5

6 Key Products Portfolio Category Non critical raw materials Key starting materials Registered Intermediates Production Line Multiproduct line Multiproduct line Dedicated line environment controlled 5 micron filtered air APIs Dedicated line Class 100,000 specifically designed for manufacture of APIs 6

7 Facilities Lab Capacity : Small Volumes 100 Gms to 5 Kgs Fume Cupboards Vessel Capacities Nutsche Filters Driers Hydrogenator 15 nos 50 ml to 20 lts 50 Gms to 5 Kgs Fluid Bed and Vacuum Tray Driers 10 lts 100 Kgs/cm2 GMP Intermediate / API: Pilot Capacities (2 plants) : 5 Kgs to 50 Kgs SS Reactors 300 to 500 lts 2.2m 3 Nutsche Filters 24 inches 2 Numbers Centrifuges 24 inches 2 Numbers Driers Tray driers, RCVD Each one 7

8 Facilities continued. GMP Intermediate/ Fine Chemicals Manufacturing. Large Scale Capacities (2 plants) : 50 Kgs to 500 Kgs Glass Lined Reactors 300 to 8000 lts 22.8m 3 SS Reactors 300 to 7000 lts 62.0m 3 Nutsche Filters (NF) & ANF 100 to 400 Kgs NF - 3 Numbers 2 KL ANF 1 number Centrifuges 36 and 48 inches 2 & 3 Numbers Driers RCVD, Tray Driers Hydrogenator 2000 lts- 40 Kgs/cm2 pressure 2 RCVD 1 Tray drier 1 Number 8

9 Facilities continued. Large Scale Manufacture of APIs under cgmp conditions : Capacity : 100 to 500 Kgs Glass Lined Reactors 5000 lts 5m 3 SS Reactors 2000 to 4000 lts 8m 3 Centrifuges 48 inches 2 Numbers Driers RCVD 2 Numbers FBD 1 Number Blender 2500 lts 1 Number 9

10 Reaction capabilities Hydrogenation Friedel Crafts reaction Alkylation Chlorination Nitration Bromination Diazotization Esterification Oxidation Reduction Resolution Grignard reaction 10

11 Regulatory Affairs, Quality Assurance and Control Manufacturing Systems and Documentation complying to cgmp, ICH Q7 guidelines Regular Internal Audits Stringent change control systems Validation Master Plans : Tech pack / Drug Master Files for APIs in CTD format Stability Data Support Analytical Method Validation Extensive Product Release Controls 11

12 Regulatory Affairs, Quality Assurance and Control Sophisticated Analytical Lab with: HPLCs, GCs, FTIR & UV Spectrometers, Auto-titrators Validated and calibrated systems Methods Development, Standardisation and Validation Analytical Development, Specification Development API / API Intermediate specifications complying to ICH CMC guidelines Method Validation as per ICH guidelines Qualified and Experienced Technical Personnel 12

13 Key Differentiators Driven by a team of dedicated scientists and approved by Department of Science and Industrial Research, Govt of India. Enhancing customer satisfaction by providing quality products is one of the basic principles that energizes the SPPL team in this current competitive market. A major portion of the investments made in manufacturing have been to achieve the highest level of process compliance and product quality In house technical expertise in the field of hydrogenation 13

14 Custom Synthesis and Contract Manufacturing Full fledged R&D lab suitable for development activities Pilot facility for scale-up Analytical method development and related functions form an integral part of the process leading to commercial process development and potentially manufacture of final molecule. The compamy s track record of development of various molecules is interestingly different and has contributed to customer delight! Integrated approach to partnering with our customers R&D and Manufacturing Manufacturing Process development Pilot Plant & Validation Commercial Manufacturing 14

15 Safety Health and Environment Environmental Safety : Specific EHS officer to monitor and scientifically dispose effluents to authorized agencies : Pai and Pai Chemicals Liquid Effluents Ramky Incinerators Solid waste Closed systems Containment kits and bunding in specific areas On site emergency plan approved by the Inspectorate of Factories and Boilers 15

16 Safety Health and Environment SHE programs Personnel Safety Personnel protective equipment Fire alarm systems Mock Drills Evacuation plans Annual medical checkup Process Safety Risk Analysis MSDS training and inclusion of critical aspects in batch records 16

17 Thank You! 17