In the pharmaceutical industry, building a manufacturing plant requires a lot of money and a lot of red tape. For companies who are looking to make medicines, but don’t have their own manufacturing plant, a loan license is a viable option. Supermax Laboratories, in Dehradun, Uttarakhand, shows how to use a loan license for pharmaceutical manufacturing.
What is a Loan License?
The loan license is a mechanism for a company (the licensee) to manufacture drugs at a licensed facility owned by another company (the lending licensee). Therefore, the licensee can market and distribute the drugs manufactured by the lending licensee under its own brand name. The licensee does not have to bear the hassle and costs associated with investing in its own manufacturing capacity. The lending licensee is bound by the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, which requires the lending licensee to manufacture in accordance with Good Manufacturing Practices (GMP).
Supermax and the Loan License Advantage
At Supermax, we are committed to delivering high-quality, affordable, and innovative medicines. Through the loan licensing route, we collaborate with GMP-certified, approved manufacturers across India, ensuring compliance with all regulatory standards while retaining full control over our formulations, quality assurance protocols, and branding.
This approach enables Supermax to:
- Accelerate product launches across therapeutic segments
- Reduce manufacturing costs and reinvest in research and development
- Ensure regulatory compliance while expanding production capacity
- Maintain consistency and quality across all product lines
Key Benefits of Loan Licensing
- Cost-Effective Production: No need for capital investment in plant infrastructure.
- Speed to Market: Quicker product rollouts due to existing manufacturing setups.
- Regulatory Simplicity: Operates under established legal and procedural frameworks.
- Scalability: Easily expand production across multiple licensed facilities.
Procedure to Obtain a Loan License
To begin manufacturing under a loan license in India, the following steps are followed:
- Selection of Manufacturer: Identify a licensed manufacturer with GMP certification.
- Application Submission: Apply to the SLA using Form 27A (for allopathic drugs), accompanied by fees and supporting documents.
- Inspection & Evaluation: Drug authorities may inspect the manufacturing site to ensure it meets standards for the proposed products.
- Issuance of Loan License: Upon approval, a loan license is granted, allowing the applicant to begin manufacturing their drugs at the partner facility.
Documents Required
- Application in Form 27A (or Form 24A for Ayurvedic products)
- Valid drug manufacturing license of the partner manufacturer
- No Objection Certificate (NOC) from the manufacturing unit
- Proof of technical staff and facility layout
- Product specifications and details
- Affidavit and company registration documents
Compliance and Quality Control at Supermax
Even under loan license arrangements, Supermax remains fully accountable for product quality, pharmacovigilance, and regulatory compliance. Our team conducts regular audits and maintains strict quality oversight at every stage of production — from raw material sourcing to finished product release.
The loan license model represents a powerful manufacturing strategy in India’s pharmaceutical sector. For Supermax, it opens the door to innovation, scalability, and cost-efficiency — while upholding our unwavering commitment to safety, efficacy, and excellence.
By combining agile manufacturing with stringent quality control, Supermax continues to deliver trusted healthcare solutions — shaping a healthier future for all.
Industry Trends and the Growing Role of Loan Licensing
India’s pharmaceutical industry is expected to reach a market size of over USD 130 billion by 2030, fueled by increased healthcare demand, government initiatives like Make in India, and growing exports. With evolving drug regulations and increased scrutiny from global agencies like the USFDA, MHRA, and WHO, companies are shifting towards operational models that balance compliance, agility, and cost-efficiency.
Loan licensing has emerged as a strategic enabler, especially for:
- Pharmaceutical marketing companies that focus on brand development.
- Start-ups and research-driven firms that lack in-house production capacity.
- Export-oriented firms that need flexibility in manufacturing for regulated and semi-regulated markets.
Supermax has been at the forefront of adopting this model, using it not only as a business solution but as a strategic pillar for growth and international expansion.
India’s Drugs and Cosmetics Act & Rules lay down the framework for all drug manufacturing practices. Compliance with these rules is mandatory — and under the loan license model, both the applicant and the manufacturer are jointly responsible for ensuring quality, safety, and consistency.
Supermax’s dedicated Regulatory Affairs Team handles:
- Dossier preparation and submission
- Regulatory inspections and audits
- Product registrations for domestic and global markets
- Documentation management and license renewals
By ensuring end-to-end regulatory support, Supermax strengthens its compliance posture, making it a reliable partner in both Indian and global markets.
Supermax’s Future Roadmap with Loan Licensing
Looking ahead, Supermax aims to expand its therapeutic portfolio through loan licensing in the following focus areas:
- Chronic care medications (cardiology, diabetes, neurology)
- Pediatrics and women’s health
- Nutraceuticals and herbal products
- Export-focused formulations compliant with EU and US guidelines
To support this, Supermax is actively:
- Forging long-term alliances with GMP- and WHO-certified manufacturers across India.
- Investing in advanced analytics and stability testing through partnered labs.
- Developing in-house formulation R&D for differentiated and value-added products.
Why Choose Supermax as a Loan License Holder?
If you’re a third-party manufacturer or contract manufacturing partner, collaborating with Supermax brings:
✅ Consistent business volume with assured product demand
✅ Professional regulatory and quality oversight
✅ Timely payments and ethical business conduct
✅ Partnership in long-term growth initiatives
For healthcare providers, retailers, and global distributors, Supermax offers:
🔹 High-quality, affordable products manufactured in state-of-the-art facilities
🔹 Compliance with Indian and global regulatory standards
🔹 Rapid product availability and new product launches
Final Thoughts
The loan license model is more than a regulatory provision — it’s a transformative business strategy. For pharmaceutical companies navigating today’s competitive and compliance-driven market, it offers a practical pathway to scale, speed, and sustainability. At Supermax, the loan licensing framework plays a pivotal role in our operational model, allowing us to focus on innovation, market expansion, and therapeutic excellence without the constraints of manufacturing infrastructure ownership.
By partnering with GMP-certified manufacturing units across India, Supermax ensures that every product adheres to the highest quality and safety standards. This approach enables us to introduce new formulations rapidly, respond to market demands efficiently, and allocate greater resources to R&D, quality assurance, and regulatory affairs.
Our strategic use of loan licenses also supports our mission to make high-quality medicines more accessible — both domestically and globally. We view this model not just as a cost-saving tool, but as a growth accelerator that enhances our agility, strengthens our supply chain, and builds long-term value for all stakeholders.
Supermax remains committed to responsible growth, ethical practices, and scientific innovation. With the loan license model at the core of our strategy, we are shaping the future of pharmaceuticals — smartly, sustainably, and with care.
Supermax: Manufacturing Smarter. Growing Stronger. Healing Better.