White-label drug manufacturing in India has emerged as a preferred business model for global pharmaceutical brands, startups, and healthcare entrepreneurs. With cost-effective production, regulatory expertise, and cutting-edge infrastructure, India offers unmatched opportunities in this domain.
Whether you’re a startup looking to launch your own OTC drug line or an established business expanding your product portfolio, this comprehensive guide will walk you through the step-by-step process of white-label drug manufacturing in India.
What is White-Label Drug Manufacturing?
White-label drug manufacturing is a model where pharmaceutical manufacturers produce medications or supplements under another company’s brand name. This allows businesses to sell high-quality pharmaceutical products without owning a manufacturing facility.
🏭 Step-by-Step Process of White-Label Drug Manufacturing in India
1. Product Ideation & Custom Formulation
Clients start by selecting the type of product—such as tablets, capsules, syrups, or topical formulations. Indian manufacturers like Tanishq Lifecare assist with:
- Product selection based on market trends
- Custom formulation development (if required)
- Ingredient sourcing and efficacy analysis
2. Legal & Regulatory Clearance
Before production, manufacturers ensure regulatory compliance with bodies like:
- CDSCO (Central Drugs Standard Control Organization)
- WHO-GMP (World Health Organization – Good Manufacturing Practices)
- USFDA (U.S. Food and Drug Administration) (for exports)
✅ You can verify CDSCO guidelines here.
3. Prototype Development & Sampling
A prototype is developed and shared with the client for:
- Stability testing
- Taste, texture, and packaging validation
- Pricing and dosage finalization
4. Bulk Production
Once the prototype is approved:
- Raw materials are procured in bulk
- Manufacturing begins under strict quality control protocols
- Every batch is tested for purity, potency, and compliance
5. Packaging & Labeling
White-label suppliers provide full branding services:
- Custom label printing
- Primary and secondary packaging
- Barcode and QR coding
- Batch numbers, expiry, and MRP as per regulations
6. Final Quality Check & Dispatch
The final product undergoes:
- Microbiological testing
- Packaging inspection
- Compliance certification
The products are then dispatched to the client for distribution or direct sale.
✅ Why Choose Indian Manufacturers for White-Label Pharma?
1. Cost-Effectiveness
India is home to some of the most affordable white-label pharma suppliers globally. Labor costs and raw material availability significantly reduce production costs.
2. Regulatory Expertise
Leading Indian manufacturers comply with global standards (WHO-GMP, USFDA), making them reliable partners for international distribution.
3. Infrastructure & Scale
Top white-label pharma companies in India like Tanishq Lifecare offer:
- Automated production units
- Dedicated R&D labs
- Fast turnaround times
4. Product Variety
From OTC drugs to nutraceuticals, manufacturers offer a wide portfolio to cater to various therapeutic areas.
🌐 Why Partner with Tanishq Lifecare?
At Tanishq Lifecare, we are among the best white-label pharma manufacturers in India, known for quality, compliance, and innovation. We specialize in:
- White-label OTC drug production
- Export-grade formulations
- Fast-track product launches for startups and SMEs
- Affordable pricing without compromising on quality
📌 FAQs – White-Label Drug Manufacturing India
1. Is white-label drug manufacturing legal in India?
Yes, white-label drug manufacturing is entirely legal in India and is governed by regulatory frameworks set by the Central Drugs Standard Control Organization (CDSCO) and the Drugs and Cosmetics Act, 1940. To ensure compliance:
- The manufacturer must possess a valid GMP or WHO-GMP license.
- Product labels must clearly mention key details such as manufacturing license number, batch number, expiry date, and drug composition.
- The marketer (brand owner) must ensure that no misleading or non-compliant health claims are made.
Tanishq Lifecare ensures all products are manufactured under strict quality standards, fully compliant with Indian drug laws. Whether you’re launching a domestic brand or exporting overseas, legal compliance is our top priority.
2. What documents are required to start a white-label pharma brand in India?
To start your own white-label pharmaceutical or nutraceutical brand in India, you’ll need the following documentation:
- Drug License: Mandatory for companies dealing with pharmaceutical drugs. It’s issued by the state drug authority.
- FSSAI License: Required if you’re marketing nutraceuticals, dietary supplements, or herbal products.
- GST Registration: Needed for invoicing and tax compliance in India.
- Brand Details: Your proposed brand name(s), logo, color scheme, and packaging preferences.
- Company Registration (optional but recommended): As a proprietorship, partnership, LLP, or private limited company.
Your white-label manufacturing partner, like Tanishq Lifecare, will guide you through each step—from documentation to regulatory assistance—making the process smooth and hassle-free.
3. Can I export white-label products from India?
Yes, you can export white-label drugs and supplements from India, provided your products meet the regulatory requirements of the target country. Tanishq Lifecare specializes in white-label pharmaceutical exports and helps you meet international compliance standards such as:
- USFDA for the United States
- EU GMP for European markets
- TGA for Australia
- PIC/S compliance for global recognition
- Country-specific product registrations and labeling requirements
We offer:
- Export documentation support (COA, MSDS, COO, etc.)
- Product customization for language and packaging
- International logistics and freight forwarding assistance
Our export-ready infrastructure ensures your products reach global markets with quality, safety, and speed.
4. What is the minimum order quantity (MOQ) for white-label manufacturing?
MOQs (Minimum Order Quantities) depend on several factors, including:
- The type of product (tablet, capsule, syrup, ointment, etc.)
- The complexity of the formulation (single vs. multivitamin, herbal blends, etc.)
- Custom packaging or label design requirements
- Regulatory documentation, if export is involved
Typically, Tanishq Lifecare offers low MOQs, starting from:
- 500 to 1,000 units for most common supplements or pharmaceutical formulations
- 2,000+ units for specialized or customized blends
This flexibility makes us an ideal partner for:
- Startups testing a new product line
- Exporters launching new brands
- Healthcare entrepreneurs seeking small-batch private labeling
We also provide economies of scale for bulk orders with competitive pricing.
5. How long does the white-label process take from start to finish?
The timeline for a white-label pharma manufacturing project depends on various factors such as product type, formulation approval, packaging design, and regulatory requirements. A typical timeline looks like this:
⏱️ Average Duration: 4–8 Weeks
Stage Breakdown:
- Product Finalization & Quote Approval: 2–4 days
- Licensing & Documentation Support: 3–7 days (if needed)
- Label & Packaging Design: 5–10 days (with client approvals)
- Raw Material Procurement & Production: 10–20 working days
- Quality Testing & Certification: 5–7 days
- Packaging, Labeling & Dispatch: 3–5 days
If the product is being exported, additional time may be required for international documentation, compliance checks, and shipping.
Tanishq Lifecare ensures transparent timelines, status updates, and on-time delivery to help you meet your go-to-market or export deadlines confidently.
For detailed regulations and guidelines, visit the official CDSCO website: https://cdsco.gov.in
Conclusion
White-label drug manufacturing in India is an excellent option for companies aiming to enter the pharmaceutical market without the heavy investment of setting up a plant. With top white-label pharma companies in India like Tanishq Lifecare, you gain a trusted partner for growth, compliance, and quality.
🚀 Start your journey with the best today – Visit Tanishq Lifecare to learn more.