About Asston Pharmaceuticals Limited
BUSINESS OVERVIEW
Asston Pharmaceuticals is engaged in the manufacturing and export of pharmaceutical formulations and nutraceutical products, operating across domestic markets and various African countries under the brand name “Asston.” The product portfolio includes tablets, capsules, oral liquids, ointments, creams, gels, lotions, and oral powders (sachets and dry syrups).
The company operates on a principal-to-principal model, supplying products to multiple corporate clients through loan licensing and contract manufacturing arrangements. It also offers formulation support to WHO-GMP-certified manufacturers, particularly for syrups, tablets, injectables, and antibiotics.
The primary manufacturing facility is located in Ambernath, Maharashtra, with dedicated floors for pharmaceutical and nutraceutical products, adhering to distinct FDA and FSSAI standards. The plant has a monthly production capacity of 8–9 crore tablets, with actual output averaging 5–6 crore tablets, depending on product weight. Additionally, the unit can produce 37.5 kiloliters of nutraceutical syrups and 30–40 lakh sachets per month.
The facility is certified by Central and State FDA, accredited by NQA, and compliant with Quality Management System (QMS) standards. It includes an in-house QA/QC department, warehouse infrastructure for controlled storage, and maintains environmental compliance under orange and green zone classifications.
The company holds over 150 registered trademarks and exports products like capsules, syrups, sachets, injectables (LVP and SVP), pediatric drugs, NTTB (New to the Basket) treatments, and eye drops to global markets including South Africa and West Africa. Finished goods are distributed directly to pharmacies and distributors.
To ensure production consistency and scalability, the company has signed five-year contracts with five WHO-GMP-certified manufacturers. One specializes in antibiotics, while the others produce generic formulations. A new loan license agreement with a Gujarat-based manufacturer is underway to scale ointment production.
The company supplies its contract partners with active pharmaceutical ingredients (APIs), excipients, and packaging materials, and also sources finished goods from other approved suppliers. All associated facilities include on-site warehousing for efficient material handling.
A dedicated regulatory department oversees formulation development, manages dossiers in compliance with global regulatory authorities, and maintains partnerships with NABL-accredited and FDA-approved labs to ensure product quality from production to export.
Since its inception in 2019, Asston Pharmaceuticals has conducted business in over 10 countries, focusing on affordable, high-quality pharmaceutical products for price-sensitive markets. As on 31 May, 2025, the have 46 Permanent employees and 6 contractual employees in various departments. The Bankers to the company are Bank of Maharashtra and ICICI Bank Limited.
INDUSTRY ANALYSIS
Indian Pharmaceutical Industry: A Comprehensive Overview
India has cemented its position as the largest global supplier of generic medicines and a leading producer of affordable vaccines. Over the past nine years, the Indian pharmaceutical industry has evolved into a dynamic and robust sector, growing at a CAGR of 9.43%, with a total turnover of ₹4,17,345 crore in FY 2023–24. The sector encompasses a wide range of segments, including generic drugs, over-the-counter (OTC) products, active pharmaceutical ingredients (APIs), biosimilars, biologics, contract research and manufacturing services (CRAMS), and vaccines.
With the highest number of USFDA-compliant manufacturing facilities outside the US and around 500 API producers contributing approximately 8% to the global API market, India is a critical player in global pharma supply chains.
Key Strengths of the Indian Pharmaceutical Industry
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Cost Efficiency: Competitive production and R&D costs.
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Skilled Talent Pool: Abundance of technically proficient scientists and managerial personnel.
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Diverse Population: Ideal for conducting large-scale clinical trials.
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Regulatory Excellence: Over 700 USFDA-approved and 2400+ WHO-GMP certified facilities.
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Government Support: Policies such as the Production Linked Incentive (PLI) scheme, Jan Aushadhi Scheme, and liberal FDI policies (100% for greenfield, 74% for brownfield).
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Biologics and Biosimilars Capabilities: Strong pipeline with long-term growth potential.
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Medical Tourism and Advanced Labs: Attracting global demand due to quality, infrastructure, and affordability.
Export Landscape
India is widely known as the "Pharmacy of the World", exporting over 60,000 generic brands across 60+ therapeutic categories. It contributes:
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20% of global generic exports by volume
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50% of vaccine demand globally
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40% of US generic demand
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25% of the UK’s medicine demand
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50% of Africa’s generics consumption
India's pharma exports totaled US$ 27.82 billion in FY24, up from US$ 25.36 billion in FY23, registering a 9.7% year-on-year growth. In April 2024 alone, exports rose 7.36% to US$ 2.43 billion. Major importing countries included:
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USA: US$ 8.73 billion (31.35% share)
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UK: US$ 784.32 million
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South Africa: US$ 718.54 million
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Netherlands: US$ 699.16 million
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France: US$ 667.49 million
India supplies anti-retroviral drugs to over 80% of global AIDS patients and has been a crucial exporter of hydroxychloroquine during global health emergencies.
Market Size and Growth Potential
The Indian pharmaceutical market was valued at US$ 49.78 billion in FY23 and is expected to reach:
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US$ 65 billion by 2024
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US$ 130 billion by 2030
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US$ 450 billion by 2047
Additional growth drivers:
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Domestic Market Growth: Expected to rise 8–10% in FY24
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Export Growth: 8% CAGR from FY18–FY23
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Biotechnology Sector: Valued at US$ 137 billion in 2022, aiming for US$ 300 billion by 2030
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Medical Devices Market: US$ 11 billion currently, projected to grow to US$ 50 billion by 2030
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Biosimilars Market: Anticipated to reach US$ 12 billion by 2025, growing at 22% CAGR
India is the third-largest API producer globally, with over 500 APIs manufactured and contributing 57% of WHO’s prequalified list.
Strategic Outlook and Policy Support
India’s pharma sector contributes around 1.72% of GDP and holds a key position in global pharmaceutical value chains. The government is focused on:
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Boosting innovation through funding and start-up support.
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Accelerating rural healthcare and increasing access to affordable generics via the Jan Aushadhi network.
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Promoting chronic care segments (cardiovascular, anti-diabetic, anti-depressants, oncology) due to the rising burden of lifestyle diseases.
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Enhancing regulatory frameworks, such as the revised Schedule-M GMP norms, to align with international best practices.
With medicine spending projected to grow 912% in the next five years, India is expected to become one of the top 10 medicine-spending nations globally.
Conclusion
The Indian pharmaceutical industry is a cornerstone of the global healthcare ecosystem. With unmatched scale, affordability, and regulatory standards, India continues to be a trusted supplier of safe and affordable medicines to the world. The growth trajectory for the sector remains strong, driven by domestic demand, export expansion, and innovation, positioning India as a future global leader in life sciences and healthcare innovation.
BUSINESS STRENGTHS
1. Formulation Expertise
Strong foundation in formulation development across diverse therapeutic segments, supported by an in-house QA/QC facility. Recognized as a reliable partner in international export markets due to consistent quality and technical capabilities.
2. Experienced Promoters
Promoters with over three decades of experience in formulations and international pharma exports have played a critical role in building the “Asston” brand and ensuring compliance with global regulatory standards.
3. Diverse Product Portfolio
Portfolio includes 100+ registered trademarks, covering generic medicines, pediatric drugs, anti-TB (NTTB) treatments, eye drops, tablets, capsules, syrups, sachets, and injectables, making Asston a one-stop solution for varied healthcare needs.
4. Strategic Location
Registered office in Navi Mumbai and manufacturing unit in Ambernath offer close proximity to the Ulwe airport, JNPT seaport, and major highways, enabling efficient logistics and export operations.
5. Skilled Workforce
A team of 50 skilled professionals oversees all stages from manufacturing to export, ensuring compliance with industry standards and maintaining product quality across supply chains.
6. Strong Contract Manufacturing Network
Ties with five WHO-GMP certified contract manufacturers and one FDA-approved in-house unit at Ambernath provide a network of six active production sites, ensuring flexibility and scalability. Expansion discussions with a Gujarat-based partner are underway.
7. Robust Quality Assurance
All products undergo stringent quality checks through a dedicated QA/QC team, ensuring compliance with domestic and international regulatory norms and maintaining consistency in deliverables.
8. Established Export Clientele
Exports primarily to pharmacies in West and South Africa, with strong relationships across 10+ international clients, focusing on emerging markets in Africa and Asia.
9. Competitive Pricing Strategy
Efficient formulation and outsourcing practices enable cost-effective pricing, offering a competitive edge in target regions, especially across price-sensitive markets.
10. Asset-Light Business Model
Operating primarily through outsourced manufacturing, the company avoids heavy capital expenditure and regulatory liabilities, ensuring lower operational risk and leaner cost structure.
BUSINESS STRATEGIES
1. Global Market Expansion
Aiming to become a leading global supplier of pharmaceutical products, with current operations in West Africa and plans to enter high-margin markets like North America and Europe through a broader portfolio of generic and branded offerings.
2. Diversification of Product Portfolio
Holds a valid nutraceutical product license and intends to introduce new products based on market demand, further expanding the current offerings.
3. Augmenting Warehouse Capacity
Existing warehouses at Ambernath and contract manufacturing sites support current operations. Plans are in place to expand storage and handling infrastructure to meet future demand and support larger export volumes and nationwide distribution.
4. Expansion of Contract Manufacturing Network
Currently partnered with five WHO-GMP certified contract manufacturers. Strategy includes increasing partnerships to diversify production risk, enhance price leverage, and scale up capacity for a growing international customer base.
5. Technology and Digital Infrastructure Upgrade
Plans to invest in ERP systems and digital tools to optimize operations, improve supply chain visibility, ensure regulatory compliance, and drive cost and time efficiency across manufacturing and distribution.
BUSINESS RISK FACTORS & CONCERNS
1. Regulatory Compliance Risk
Operations are subject to extensive regulation in India and abroad. Non-compliance with pharmaceutical, safety, environmental, labor, or health regulations (such as the Environment Protection Act, Air and Water Pollution Acts, and Bio-Medical Waste Rules) may adversely impact business operations and financial performance.
2. Dependence on Third-Party Manufacturers
While a dedicated facility exists at Ambernath, Maharashtra, production of several formulations relies on contract manufacturing. Currently, four contract manufacturers are engaged, with expansion discussions underway to add a fifth partner in Gujarat. Production lead times average 60 days post-purchase order. Disruptions or quality issues at third-party units could impact delivery schedules and customer satisfaction.
3. Customer Concentration Risk
Revenue is highly concentrated, with the top ten customers contributing over 97% of revenue in FY24, and 100% in FY23 and FY22. Only two customers are under one-year contracts, while others operate on a purchase-order basis. Loss of major customers or fluctuations in demand can significantly impact revenues.
4. Geographic Concentration Risk
All owned and contract manufacturing units, along with the registered office, are located in Maharashtra, leading to regional concentration risk. Any disruption—due to natural disasters, political instability, workforce issues, or regulatory hurdles—in this region could severely affect production and supply chains.
Asston Pharmaceuticals faces key risks related to regulatory compliance, heavy reliance on third-party manufacturers, customer concentration, and regional operational dependency. These risks, if unmitigated, could affect the company's supply continuity, financial health, and business sustainability.
