### **Overview** Vivimed Labs Limited, headquartered in Hyderabad, India, is a global pharmaceutical company with over three decades of presence in the healthcare and specialty chemicals sectors. Founded in 1988 (incorporated in 1989), the company has evolved from a contract manufacturer into a diversified player focused on the development, manufacturing, and commercialization of **generic and branded generic formulations** for regulated and semi-regulated markets. The company previously operated as an integrated entity with presence in **APIs (Active Pharmaceutical Ingredients), Finished Dosage Forms (FDF), and Specialty Chemicals**, but has strategically divested its API/CDMO and specialty dyes business to focus primarily on **formulations** and **export-driven growth**. As of 2025, Vivimed Labs’ core operations center around **solid and complex dosage form development**, **ophthalmic and nasal formulations**, **contract development and manufacturing (CDMO)**, and **innovation-led R&D** through its dedicated unit, **Finoso Pharma Pvt. Ltd.** --- ### **Strategic Focus & Business Model** #### **1. Strategic Pivot (2020–2025)** - **Divestment of Non-Core Assets**: - Exited its API/CDMO business in FY22 due to rising costs and margin pressures. - Divested **Vivimed Specialty Chemicals** (hair dyes & photochromics) in 2019 to reduce leverage and refocus on pharmaceuticals. - Monetized stake in **Uquifa s.a.** (former API arm with USFDA facilities) between 2020–2024, retaining minority ownership. - **Strategic Shift in Markets**: - Moved from **highly competitive regulated markets (e.g., U.S.)** to **semi-regulated and underpenetrated geographies (e.g., CIS, Middle East, Africa, Canada, Latin America)**. - Identified higher-margin, lower-competition opportunities in fast-growing **"pharmerging" markets**. - **Delivery Platform Expansion**: - Transitioning from solid dosage (IR/MR tablets) to **sterile and semi-solid platforms**, including **ophthalmic suspensions, nasal sprays**, and **oral liquids**. - Strengthening R&D and manufacturing capabilities in **complex and differentiated formulations**. #### **2. Core Business Verticals (Post-2023)** | Segment | Focus | |--------|-------| | **Finished Dosage Formulations (FDF)** | Core revenue driver; includes generics, branded generics, export formulations, and CDMO services. Focus on **complex generics** (e.g., MR tablets, antidiabetics, anticoagulants) and **new delivery systems**. | | **Contract Manufacturing (CMO/CDMO)** | Offers end-to-end services for multinationals and domestic pharma companies. Key clients in Canada, Russia, CIS, and the Middle East. | | **R&D & Innovation** | Driven by **Finoso Pharma Pvt. Ltd.** – in-house CDMO/CRO unit focusing on product development, tech transfer, and regulatory filings. | #### **3. Subsidiaries & Global Structure** Key subsidiaries supporting international operations: - **Finoso Pharma Pvt. Ltd.** (India) – Dedicated R&D and CDMO hub. - **Vivimed Labs USA Inc.** (New Jersey) - **Vivimed Holdings Limited** (Hong Kong) - **Vivimed Labs Mauritius Limited** These entities facilitate global regulatory compliance, product registrations, and CDMO partnerships. --- ### **Research & Development (R&D)** #### **R&D Focus Areas** - Developing **generic products** for **regulated markets** (U.S., Canada, Europe, Australia). - Building a portfolio of **high-volume OTC drugs** and **complex generics** with chemistry/formulation challenges. - Expanding through **line extensions, value-added innovations (e.g., extended-release formulations), and out-licensing**. - Focus on **short- and long-term revenue projects** across **chemistry, IP, regulatory, and manufacturing complexity**. #### **Capabilities** - End-to-end drug development: - Pre-formulation → Formulation → Analytical Development → cGMP Scale-up → Stability Testing → BA/BE Support. - Technical expertise in: - Immediate Release (IR) and Modified Release (MR) solid oral dosages. - Ophthalmic, nasal, oral liquid, and otic formulations. - Regulatory filings in: - **U.S., Canada, EU, Australia, CIS, Middle East, Africa, Latin America, and Southeast Asia**. - ANDA and dossier submissions supported for multiple geographies. #### **R&D Expenditure** - R&D spend increased from **₹2.11 crore (FY23)** to **₹4.22 crore (FY24)** – all as revenue expenditure, no capital outlay. - Significant increase from earlier highs (₹264 crore in FY21) due to strategic realignment, now optimized for focused innovation. #### **Key R&D Achievements (2023–2025)** - **Positive pivotal bioequivalence studies** for Rupatidine, Bilastine, Sertraline, and Sitagliptin+Metformin. - Successful **scale-up and commercial supply** of: - Bilastine Tablets - Rivaroxaban Tablets - Edoxaban Tablets - Dalfampridine Tablets - Development of **complex formulations**: - Empagliflozin (IR) - Sitagliptin + Metformin (IR and ER) - Molnupiravir Capsules, Favipiravir Tablets - Filed dossiers in **Bolivia, Vietnam, Tanzania, Philippines, Mexico, Zambia, Saudi Arabia, Chile**. - **Out-licensing**: 2 product dossiers licensed to clients in Saudi Arabia. - New **parenteral R&D analytical section** established in 2023. - Collaborations with clients in **EU, Canada, India, Australia** for tech transfer and product development. --- ### **Manufacturing & Regulatory Compliance** - **6 manufacturing facilities** in India (including units in **Bidar, Jeedimetla, Haridwar**). - Major sites approved by: - **Health Canada**, **PICS/GMP**, **Ukraine Ministry of Health**, **Russian GMP authorities**. - **Unit 2 (Jeedimetla)**: - PICS and Health Canada approval for **ophthalmic and nasal products**. - Passed Russian regulatory inspection (Q1 FY24), enabling large-volume CDMO deals. - **Haridwar site**: Approved to supply nasal sprays to Cambodia and other CIS nations. --- ### **Commercial & Market Performance (2023–2025)** #### **Recent Launches & Approvals** - **Bilastine Tablets**: - Launched in Kyrgyzstan (initial order: **$15,000**). - Approvals secured in **Ukraine, Azerbaijan, Kyrgyzstan**. - Commercial order received from **Propharma Ukraine**. - Regulatory filings underway in **U.S., Canada, Saudi Arabia**; approvals expected in **Q1 FY26**. - **Rupatidine**: - Regulatory filings ongoing; approvals expected in **Q1 FY26**. - **Edoxaban**: - Filings submitted in **Bolivia and Chile**; commercial orders received from **ROW markets**. - **Chlorthalidone (Canada)**: - 10mg and 20mg commercially launched. - **Allopurinol (Canada)**: - Approved in 100mg, 200mg, 300mg – launch delayed due to customer-side issues. - **Empagliflozin (10/25mg)**: - Filed in **Saudi Arabia, Mexico, Zambia**. - Approved for launch in **Canada (May 2026)**. - **Ophthalmic Products**: - **11 ophthalmic products commercialized in Africa**. - Regulatory submissions completed in **Philippines, ROW countries**. - Strong pipeline of ophthalmic and ocular formulations. #### **Export Growth** - **Uzbekistan**: Secured strategic export order worth **$200,000** for oral liquids in Q4 FY24. - **Cambodia, Kyrgyzstan, Uzbekistan**: Fulfilling nasal spray orders from Haridwar. - **Canada**: Strong traction with regulatory approvals and commercial supply. - **CIS Markets**: Expanded footprint from 3 products (FY19) to 18+ (FY24), with 10+ dossiers approved. - **Africa**: Positioning as a key supplier of ophthalmic and oral liquid products. #### **Key CDMO Agreements** - **Canada**: 5 CDMO projects signed with new client; engaged with major partners for future generic offtake. - **Russia**: Signed **18 CDMO projects** with leading pharma company (13 ophthalmic + 5 otic products). - **Duo Pharma (Malaysia)**: CDMO agreement for **Brimonidine eye drops**. - **GCC, CIS, EU**: Partnerships established for product development and regulatory filings. --- ### **Domestic Business (India)** - **Domestic Branded FDF Segment**: - Averaged **₹2 crore/month sales** in FY24. - Potential to scale to **₹3 crore/month** with new product launches. - Challenged by high **field force attrition and compensation misalignment**. - Initiatives underway to **stabilize remuneration for MRs and Area Managers**. - **Institutional Sales**: - ₹40 crore revenue in FY23, primarily from **Telangana’s TSMIDC**. - Banking issues affected tender participation in FY23; expected resolution in FY25. - **Vilberry Brands Integration**: Contributed marginally in FY23; full benefits expected in current year.