The third-party manufacturing model allows pharmaceutical companies to outsource production while focusing on marketing and distribution. It is a widely used model in India, especially by startups and small-scale enterprises.
Montelukast and Levocetirizine Hydrochloride Tablets IP is used to treat allergic rhinitis and related symptoms. This product falls under the anti-allergic/antihistaminic therapeutic segment, which sees consistent demand due to common allergic conditions in urban and rural populations.
Also read this: Levocetirizine Hydrochloride Tablets IP 5mg
Product Overview of Montelukast and Levocetirizine Hydrochloride Tablets IP:
- Composition: Montelukast Sodium 10 mg + Levocetirizine Hydrochloride 5 mg
- Dosage Form: Tablet
- Uses: Relief from allergic rhinitis, nasal congestion, chronic urticaria
- Regulatory Status: Prescription drug (Rx), listed under Schedule H in India
Third-Party Manufacturing Process
- Inquiry: Discuss product, quantity, and packaging
- Quotation: The Manufacturer provides cost and timelines
- Documentation: Required documents include:
- Drug License (Form 20B/21B)
- GST registration
- PAN card
- Letter of Intent (LOI)
- Order Confirmation: Advance payment and design approval
- Production: Manufactured as per approved formulation
- Dispatch: Quality check, packaging, and shipment
Manufacturer vs. Marketer
- Manufacturer: Handles formulation, compliance, testing
- Marketing Company: Responsible for brand promotion and sales
Quality & Compliance
- Manufacturing as per WHO-GMP and ISO standards
- Tests include assay, dissolution, uniformity, and stability
- Labeling must comply with the Drugs and Cosmetics Rules
Packaging: Options include Alu-Alu or blister. Each strip must carry product details, batch no, expiry, MRP, and mandatory warnings.
Cost and Investment of Montelukast and Levocetirizine Hydrochloride Tablets IP:
- MOQ: 500 boxes (10×10 tablets)
- Cost Elements:
- Raw material
- Packaging
- Testing
- Freight
- GST @12%
- Estimated Price Range: INR 28,000–34,000 per 500 boxes
Cost Optimization Tips
- Use standard packaging
- Order in bulk
- Confirm all details before production
How to Choose a Manufacturer
- Verify licenses and certifications
- Assess manufacturing capacity and timelines
- Ask about repeat order timelines and QC practices
Red Flags
- No valid license
- Incomplete communication
- Poor facility standards
Marketing & Branding Strategy
- Use clear, compliant packaging
- Distribute promotional items (MR bags, visual aids)
- List products on pharma directories and B2B platforms
Regulatory Compliance
- Include statutory declarations on labels
- Track and report adverse reactions (pharmacovigilance)
- Maintain legal and product liability records
FAQs:- Montelukast and Levocetirizine Hydrochloride Tablets IP:
1. What documents are needed to start third-party manufacturing?
Drug License, GST, PAN, LOI
2. What is the MOQ?
500 boxes (10×10 tablets)
3. What is the production timeline?
30–35 days initially, 20–25 days for repeat orders
4. Can I customize packaging and use my brand name?
Yes, most manufacturers offer this service
5. What certifications should a manufacturer have?
WHO-GMP and ISO
6. What is the current price for manufacturing this product?
Approx. INR 28,000–34,000 for 500 boxes
7. Is pharmacovigilance required?
Yes, for marketed brands
