### **Overview** Shivalik Rasayan Limited (SRL) is a prominent Indian manufacturer specializing in **agrochemicals**, **active pharmaceutical ingredients (APIs)**, and **specialty chemicals**. With over four decades of operational experience since its inception in 1981, the company has established itself as a key player in both domestic and international markets. It combines robust manufacturing capabilities, a DSIR-approved R&D center, and global regulatory compliance to deliver high-quality, cost-effective, and non-infringing chemical products. SRL serves a diversified portfolio of markets across India, the U.S., Europe, China, Japan, and over 30 countries globally. The company is strategically expanding from its stronghold in agrochemicals into regulated pharmaceutical markets, leveraging its integrated operations and innovation-driven business model. --- ### **Core Business Segments** 1. **Agrochemicals** 2. **Active Pharmaceutical Ingredients (APIs)** 3. **Specialty & Synthetic Organic Chemicals** --- ### **Key Highlights (as of Sep–Nov 2025)** #### **1. Regulatory Milestones & Global Market Access** - In **October 2024**, the company’s **API manufacturing facility at Dahej-II (Gujarat)** received **US FDA approval**, a significant milestone enabling access to high-compliance markets like the U.S., Europe, and Japan. - The facility is also **WHO-GMP certified** and has secured **six Certificate of Suitability (CEP)** approvals from the European Directorate for the Quality of Medicines (EDQM). - **Drug Master Files (DMFs)** have been submitted to the USFDA for high-value oncology APIs including **Bortezomib**, **Palbociclib**, and **Busulfan**. - The company has filed dossiers for five APIs in China via a local marketing partner and submitted regulatory applications for Apixaban and Linagliptin. #### **2. Strategic Partnerships & Commercial Expansion** - Entered a **strategic partnership with a leading U.S.-based firm** to co-develop **five complex molecules**, signaling rising confidence in SRL’s R&D and manufacturing excellence. - Collaborating with a **Chinese marketing firm** for API distribution in China; one dossier already submitted to China’s NMPA, two under evaluation. - Engaged in **advanced discussions with major Japanese pharmaceutical firms** to develop non-infringing versions of **Ibrutinib** and **Lenvatinib** APIs. - A Chinese company has engaged SRL to manufacture and supply three APIs for the Chinese market, reinforcing India’s role as a global API hub. #### **3. Manufacturing & Capacity Expansion** - Commissioned its **state-of-the-art greenfield plant at Dahej-III (Gujarat)** in **September 2024**, adding: - **2,000 MT/year** capacity for insecticides and fungicides. - A **3,500 MTPA phase-one block**, with future plans for herbicides and specialty chemicals. - **Dimethoate Technical production capacity increased by 250%** — from 1,450 MTPA to **5,000 MTPA**, solidifying SRL’s position as **India’s largest domestic producer**. - Total production capacity across all facilities stands at **21,550 MT/year**, with a total plant area of **50,000 sq. m.** #### **4. R&D Leadership & Innovation** - Operates a **DSIR-recognized R&D center in Bhiwadi (Rajasthan)**, spanning **12,000 sq. ft.** with an investment exceeding **Rs. 40 crores**. - Staffed by **over 60 scientists and pharmacists**, the center focuses on: - Re-engineering complex chemistries in pharma and agrochemicals. - Developing **non-infringing processes** for patent-expired molecules. - Innovations in **cancer drug delivery systems** and **genotoxic impurity profiling**. - Successfully developed **indigenous, import-substitute processes** for agrochemicals such as: - **Azoxystrobin Technical** - **Chlorantraniliprole Technical (CTPR)** - **Trifloxystrobin**, **Dinotefuran**, **Pymetrozine** - Holds **two U.S. patents** (granted Dec 2022) for highly pure **Fingolimod Hydrochloride** and **Temozolomide**, underscoring IP leadership. #### **5. Product Pipeline & Development Focus** - **API Development**: - **20 APIs** (oncology and non-oncology) under development; 8 oncology and 5 non-oncology molecules validated. - Includes high-revenue targets: **Abiraterone**, **Lenalidomide**, **Pirfenidone**, **Fingolimod**, and **Dimethyl Fumarate**. - **Agrochemical Pipeline**: - **34 agrochemical products** pending approval from India’s **Central Insecticides Board & Registration Committee (CIB&RC)**. - Developing **7 agrochemical products for European markets** under the **CDMO model**. - New molecules: **Novaluron** (insecticide) – slated for distribution next fiscal year; **Trifloxystrobin** (fungicide) – in plant trial phase with commercialization within 2–3 years. #### **6. Financial & Operational Performance** - Agrochemicals contribute **~94% of revenue**, primarily from **Dimethoate** and **Malathion Technical**. - Generated **Rs. 50 crores in agrochemical revenue** in FY 2024–25, driven by process optimization and market demand. - The **Dehradun facility** operates at **95% capacity utilization**, producing 1,450 MT annually. - Strategic investments in **Dahej-III** and regulatory readiness are expected to drive **sustained revenue growth** in global agrochemical and API markets. --- ### **Growth Strategy** Shivalik Rasayan’s strategy is built on **three interconnected pillars**: 1. **API Excellence**: Expanding into **regulated markets (US, EU, China, Japan)** via US FDA approval, CEPs, and local partnerships. 2. **Agrochemical Leadership**: Scaling capacity for **high-value, off-patent molecules** like Novaluron and Trifloxystrobin, while strengthening export potential. 3. **R&D-Driven Innovation**: Focused on **non-infringing, cost-effective processes**, import substitution, and **contract development & manufacturing (CDMO/CRAMS)** services for global clients. --- ### **Manufacturing Footprint** | Facility | Location | Key Features | |--------|--------|-------------| | **Dahej-II API Plant** | Gujarat | - US FDA & WHO-GMP approved<br>- 50,000 sq. m. area<br>- Oncology & non-oncology blocks (2 operational, 6 planned) | | **Dahej-III Agro & Specialty Plant** | Gujarat | - Operational since Sep 2024<br>- 2,000–20,100 MTPA capacity<br>- Phase I: Insecticides & Fungicides | | **Dehradun Agrochemical Plant** | Uttarakhand | - 1,450 MT/year capacity<br>- 95% utilization<br>- 20-acre site with modern infrastructure | | **R&D Center** | Bhiwadi, Rajasthan | - DSIR-approved, 12,000 sq. ft.<br>- 60+ scientists<br>- Full capabilities in chemical, analytical, and formulation R&D | --- ### **Corporate & ESG Profile** - **Workforce**: Over **250 employees** across three manufacturing sites. - **Sustainability**: Dahej-III plant built with green manufacturing practices; environmental clearance secured for large-scale production. - **IP Portfolio**: Multiple patents filed (including PCT), with focus on process innovation and impurity control.