India’s pharmaceutical industry frequently uses the process of loan license manufacturing (also known as toll manufacturing) to allow companies to outsource manufacturing without having their own manufacturing license. Loan license manufacturing in Delhi is especially beneficial for startups, marketers, e-commerce pharma companies, or foreign companies wanting to efficiently enter the Indian market without developing their own facility.
🔍 What is a Loan License (Forms 25A / 28A)?
Loan license manufacturing allows Company A (the “loan licensee”) to manufacture a medicine under its brand using Company B’s licensed manufacturing unit under the Drugs and Cosmetics Act. This arrangement has the benefit of a license without incurring costs and without investing in capital of a facility. Company A must adhere to Schedule M/GMP norms and obtain the necessary manufacturing license (Form 25A for Non-Scheduled Drugs, Form 28A for Injectables etc.) The licensor has to allow full access ad irrevocable access to their compliant, full-scale facility, technical manpower, QA/QC systems, and environmental controls (such as effluent treatment).
✅ Why a Loan License Model?
- Cost-effective means of entering manufacturing without having to operate a plant
- Scalability & flexibility – small or large batches and termination in different dosage forms
- Compliance with compliance is ensured by the licensor’s certified facilities and technically competent team
- The Manufacturer will also assist with regulatory compliance and dossier preparation
🌟 Supermax Laboratories: A First Class Loan License Partner
Supermax Laboratories was founded in the late 80s (or 1990) in Delhi. Supermax Laboratories operates multiple WHO-GMP and ISO-certified manufacturing facilities within the DSIIDC industrial area in Delhi (Unit-I and Unit-III) as well as Uttarakhand. Our Delhi plants have over 20,000 sqm of compliant infrastructure, in-house QA/QC laboratories, and highly trained staff.
Supermax highlights loan license manufacturing as one of their key services and says—“Partner access to our facility and license, producing pharmaceuticals under your branding and total regulatory compliance.”
🧪 Capabilities & Compliance
Supermax’s manufacturing capabilities include tablets (coated, chewable, effervescent), capsules, liquid orals, dry syrups, sachets, and injectables. Beta‑lactam and non‑Beta products are manufactured in separate, contamination-free zones, with fully compliant AHU/HVAC systems, zero-discharge effluent treatment plants, and rigorously enforced environmental and separation controls.
Quality measures include calibrated instruments (HPLC, GC, FTIR), documented batch release practices, environmental monitoring, and strict QA/QC supervision by qualified pharmacists and chemists, based on Supermax’s motto “Supreme Quality with Maximum Therapeutics.”
🚀 Advantages of Working with Supermax for Loan License Manufacturing
Certification & Trustworthiness: WHO- GMP and ISO 9001:2015/2017 certified, obtaining FDA-indi approvals with a proven history since 1987/1990.
Flexible Manufacturing: Capable of addressing small -large batch size, multiple dosages and therapeutic categories makes them great for exporters & private labels, or third party brands.
Regulatory Expertise: Acts as a collective for its clients, helps in dossier submission, compliance documentation, and licensing, and significantly reduces the legal burden on the licensee .
Benefit from Reduced Cost: Buying the products under a loan license reduces overheads such as land, construction and pollution clearances. Supermax’s Delhi facilities already have all necessary SPCB consents and adequate ETP infrastructure.
Getting to market quicker because you avoid delays from new product registration. Your production can commence more quickly with existing and certified lines. Capacity exists.
Summary
If you want to tap into the potential of the Indian pharma market and gain access to an efficient production pathway without the investment in infrastructure, loan license manufacturing in Delhi is a good option. Supermax Laboratories, with over 30 years of experience in the domestic and international markets and multiple GMP certified facilities in Delhi and Uttarakhand, can support you through full end to end support, from manufacturing, pharma production planning, quality assurance, and regulatory compliance. This means that brand owners and marketers can put together their pharma portfolios with confidence, leveraging Supermax’s major infrastructure, expertise and compliance systems.
If you want to launch your pharmaceutical brand or want to be able to efficiently outsource your manufacturing to India, entering a loan license agreement with Supermax Laboratories is a good strategic move. Please let me know if you would like me to provide information about a specific formulation, or export market, or if you want to provide me with your business plan!