Medicamen Biotech Limited
2,305words
9turns
0analyst exchanges
0executives
Key numbers — 11 extracted
150 million
40 million
rs
52.92
47.08%
44.83%
44.20%
10.97%
Rs 30 crore
1450 MT
95%
3500 MT
Speaking time
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Opening remarks
Additional Services
CDO, CMO & CRAMS R&D Center Bhiwadi Agrochemicals Plant Dehradun API Plant Dahej Agro- & Speciality Chemicals Plant (to be ready in 2023) Dahej Non-Oncology FDF Bhiwadi Non-Oncology FDF, Unit-1 Haridwar Oncology FDF, Unit-2 Haridwar API = Active Pharmaceutical Ingredient, FDF = Finished Dosage Form, CDO = Contract Development Organization, CMO = Contract Manufacturing Organization, CRAMS = Contract Research And Manufacturing Services Confidential 5 Group Structure Shareholding as of June 30, 2021 Promoters 52.92% Public 47.08% SRL 44.83% Public 44.20% 10.97% Pharmadenica A/S, Denmark Shivalik Rasayan Ltd (SRL) Medicamen Biotech Ltd (MBL) Confidential 6 Milestones d e t i m i L n a y a s a R k i l a v i h S 1 1980- 99 1981: Commences commercial production - Dehradun Agrochemical Plant 1985: Company declared sick & registered with BIFR 1 1980- 99 1996: Operations started - Bhiwadi FDF Plant (non-onco) 1998: WHO-GMP approval – Bhiwadi FDF Plant (non-onco) 2002: Company taken over by Rahul
Product selection criteria
* attractive market size * patent expiry launches * low competition S No Product API by SRL Global Revenues* S No Product API by SRL Global Revenues* 1 2 3 4 5 6 7 8 Abiraterone Planned $ 3.2 b Bortezomib Available $ 1.5 b Dasatinib Planned $ 2.3 b Ibrutinib Planned $ 5.8 b Lenalidomide Planned $ 5.7 b Nilotinib Planned $ 1.6 b Palbociclib Planned $ 5.7 b Pemetrexed Planned $ 2.5 b 1 2 3 4 5 6 7 8 Carfilzomib Planned $ 1.1 b Cabozanitinib Planned $ 1.0 b Lenvatinib Acalabrutinib Pazopanib Planned Planned Planned $ 0.6 b $ 0.2 b $ 0.6 b Capecitabine Available $ 0.7 b Azacitidine Available $ 0.7 b Bendamustine Available $ 0.7 b * Note IQVIA, MAT Q1-2020 Products protected by valid patents (of innovators / third parties) are not offered for commercialization / sale in countries where the sale of such products constitutes a patent infringement Confidential 15 Non-Oncology APIs
Well thought after product strategy
• • Products with attractive global revenues (> $ 1b) Substantial expected revenues for SRL Development Completed # 1 2 3 API Dimethyl Fumarate Fingolimod Pirfenidone Global Revenues* $ 4.9 b $ 3.7 b $ 1.3 b Under Development (>20 APIs) # 1 2 3 API Saxagliptin Sitagliptin Phosphate Vildagliptin # 4 5 6 API Monomethly Fumarate Acebrophylline Sofosbuvir * Note IQVIA, MAT Q1-2020 Products protected by valid patents (of innovators / third parties) are not offered for commercialization / sale in countries where the sale of such products constitutes a patent infringement Confidential 16 Contents Corporate Overview Portfolio & Pipeline R&D and Manufacturing Strategy & Plans Confidential 17 R&D and Manufacturing At A Glance New Delhi Head Office 1 R&D Center Bhiwadi 5 Non-Onco FDF Plant 4 API Plant Dahej 3 Agro- & Speciality Chem Plant Dahej Dehradun Agrochemicals Plant 2 Haridwar Unit-1: Non-onco FDF Plant Unit-2: Onco FDF Plant 6 7 Confidential 18 1 R&D Center Bhiwadi Confidential 19 1 R&D C
Fungicides
• Planned annual capacity: 3500 MT • Operation commencement expected in Jan 2023 Confidential 22 4 API Plant Dahej Confidential 23 Confidential 23 4 API Plant Dahej • Site area of 50,000 m2 including all production blocks, buildings, utilities* • Design complaint with best-in-class regulatory requirements (US, Europe, Japan) • 4 oncology & 4 non-oncology blocks planned: thereof 1 onco & 1 non- onco block presently operational • Robust GMP compliant containment facility to rule out cross contamination between onco & non-onco APIs • Extensive use of Active & Passive valves at various stages of process to achieve full containment • Containment compliance starting from active raw material & API sampling to dispensing • Tested & validated technology transfer capabilities from R&D center to production floor • Fully equipped in-house quality control laboratory for chemical & microbiological testing • On-site regulatory affairs department experienced in approval requirements of all major geogr
Injectable Section
• Capacity of 120 vials/min with flexibility of handling different vial sizes, integrated with Particle Monitoring System for non-viable particle counting (NVPC) • 5.6 m2 with 6+1 radiant shelves Lyophilization Unit from LSI having self-stoppering facility • Unit Preparation & Sterilization: A double-door autoclave, SCADA (Supervisory Control and Data Acquisition) operated 10 litre & 50 litre capacity for manufacturing or holding vessel with filtration skid installed in between LAF/DPB units to maintain sterility of the products • A dedicated MLAF Unit for lyophilizer loading and unloading SCADA: Sterile Manufacturing Integrated Vial Filling Line Confidential Confidential 28 7 Tablet Compression in Isolator Integrated Line FBD Oncology FDF Plant Unit-2: Haridwar Oral Solid Dose (OSD) Section: • • • • • Integrated Granulation line (Glatt , 30 Kg capacity) with WIP technology & interchangeable bowl size Tablet compression & encapsulation with Isolators Tablet coater with WIP technology (
Global Head Quarters
1506 Chiranjiv Tower, 43 Nehru Place, New Delhi – 110019, India info@shivalikrasayan.com +91 11 47589500