### **Overview** **Medicamen Biotech Limited (MBL)** is a fully integrated, research-driven pharmaceutical company founded in December 1993 and headquartered in New Delhi, India. Under the strategic leadership of Chairman Rahul Bishnoi and backed by parent company **Shivalik Rasayan Limited (SRL)**, MBL has transformed from a domestic-focused manufacturer into a high-growth, globally oriented enterprise. The company operates across the entire pharmaceutical value chain—R&D, Active Pharmaceutical Ingredient (API) manufacturing, formulation development, and commercialization—positioning itself as a rare vertically integrated player in the Indian pharma landscape. With operations in **over 35 countries**, MBL serves emerging and regulated markets with a diverse portfolio of generic medicines and specialized oncology therapeutics. The company has recently entered a growth inflection phase, driven by regulatory approvals, manufacturing scale-up, and a focused expansion into high-value markets. --- ### **Key Strategic Developments (2023–2025)** #### **1. Regulatory Milestones & Market Access** - **EU GMP Approval (Sep 2024):** Bhiwadi manufacturing facility approved by EU (via Greece), enabling seamless market access across Europe. - **US FDA Approval (Oct 2024):** Haridwar oncology plant received full US FDA approval, supporting supply to the U.S. market. - **First US ANDA Approval (Jun 2025):** Bortezomib Injection 3.5 mg approved under ANDA, marking successful entry into the regulated U.S. generics market. - **TGA (Australia) & Health Canada Submissions:** Dossier filings ongoing; TGA approval expected by Sep 2025, with Canada plant audit in process. - **Desktop Approvals:** Leveraging USFDA and EU approvals to fast-track product registrations in Canada, Australia, Vietnam, and other SRA-recognized markets. #### **2. Manufacturing & Infrastructure Scale-Up** MBL operates **three WHO-GMP, US FDA, and EU-compliant manufacturing facilities**: - **Bhiwadi, Rajasthan (210,000 sq. ft):** - General formulations: Beta-lactam & non-beta-lactam tablets, capsules, dry/liquid syrups, ORS, iron-folic acid tablets. - Includes dedicated R&D and QC blocks. - **Haridwar Unit I (32,000 sq. ft):** - General dosage forms: tablets, capsules, liquid orals, ointments, and creams. - WHO-GMP certified; supplies both domestic and international markets. - **Haridwar Unit II (35,000 sq. ft):** - State-of-the-art **oncology-dedicated facility** producing injectables (including lyophilized and ready-to-use), oral solids, and NDDS. - Compliant with USFDA, EU, PMDA (Japan), and TGA standards. Total workforce: **400+ employees**, including 110 pharmacists and a 20-member dedicated regulatory affairs team. --- ### **Commercial Strategy & Market Expansion** #### **Geographic Focus** - **Global Presence:** Active in over 35 countries across Africa, Latin America, MENA, Asia-Pacific, and now expanding into the U.S., EU, and Australia. - **Export Orientation:** ~80% of revenue from international markets, with 70–75% of exports historically concentrated in Africa. - **Diversification Strategy:** Actively reducing dependency on Africa by entering **regulated markets (U.S., EU, Canada, Australia)** and emerging hubs (South Africa, Francophone Africa, Southeast Asia). #### **Recent Market Progress** - **Africa:** 70 product registrations in Ethiopia, 50+ in Ghana, and 600+ dossiers filed/pending in **Francophone Africa** via strategic partnership with **Eurapharma**. - **Europe:** Two marketing authorizations filed in Denmark; distribution agreement for three products; CDMO collaboration with XGX Pharma. - **South Africa:** Entered into partnership with a major South African conglomerate to access the $4 billion pharmaceutical market. - **U.S.:** First ANDA approved; partnered with U.S.-based firm for third-party oncology manufacturing and distribution. - **Australia:** 5 dossiers submitted for TGA approval; 10 products ready for filing by 2027–28. --- ### **Product Portfolio & R&D Pipeline** #### **Therapeutic Focus** - **Core Segments:** Oncology, Cardiovascular (CVD), Diabetes, Pain Management, Anti-infectives, Iron Therapy. - **High-Growth Areas:** Oncology (targeting 15% CAGR), Diabetes (13.8% CAGR), CVD (10.3% CAGR). #### **R&D Strength** - Led by **Dr. V.K. Singh (28+ years, 30+ global patents)**. - In-house capabilities: formulation development, analytical research, stability studies, process validation, IP management, Para IV filings. - **160+ registered products globally; 250+ in registration/filing pipeline.** - Key projects: - 50 oncology and CVD SKUs under development for U.S., EU, Canada, Australia (launch expected by 2027–28). - 10 non-oncology EU-targeted formulations in pipeline. - 7 products in co-development with European partner (including repurposed drug with new patent filing). - Focus on **difficult-to-manufacture, low-competition, off-patent molecules** (e.g., Abiraterone, Ibrutinib, Lenalidomide). --- ### **Business Model & Growth Drivers** #### **1. Dual Growth Engine** - **Branded Generics (Domestic India):** - Subsidiary **Medicamen Life Sciences** launched in 2022 to build strong branded presence in **CVD, diabetes, and pain management**. - 74 SKUs launched; 100-person sales team; distribution in 21 states. - Break-even expected by FY 2025–26; long-term goal: expansion into dermatology, orthopedics, and gastroenterology. - **Global Export & CDMO Services:** - Secured **three CDMO contracts with U.S.-based partners**. - Partnership with Canadian and Danish firms for tech transfer and manufacturing of 7 products. - Vision: Establish CDMO arm as a **profit center** and global preferred partner. #### **2. Oncology as a Growth Pillar** - **Vivo Oncology:** Launched in Nov 2024 with 12 products; supplies major Indian hospitals (Tata Memorial, AIIMS, Fortis, Max). - Dedicated 30+ specialist salesforce. - Global oncology rollout planned in U.S., EU, LATAM, APAC, MENA via internal teams and partners. --- ### **Leadership & Governance** - **Rahul Bishnoi (Chairman):** CA, first-generation entrepreneur with 30+ years in pharma and agrochemicals. Led turnaround of both Shivalik Rasayan (2002) and Medicamen (2016). - **Experienced Team:** - *Prashant Kumar*: 17+ years in aseptic manufacturing and FDA audits (Oncology Head). - *Dr. Manu*: PhD, 20+ years in regulatory strategy. - *Dr. Shrawat (Non-Exec Director)*: 30+ years, ex-Ranbaxy, Jubilant, Dabur Pharma.