In today’s dynamic pharmaceutical market, third party manufacturing of levocetirizine hydrochloride tablets IP 5mg has emerged as a preferred business model for distributors, wholesalers, and marketing companies aiming to launch their own branded generics without owning a manufacturing unit. It allows businesses to focus on sales and marketing while leveraging the infrastructure and compliance of WHO-GMP certified manufacturers.
Among the various formulations in demand, Levocetirizine Dihydrochloride Tablets IP 5mg is a top contender in the antiallergic/antihistamine category. It is widely used to treat allergic rhinitis, hay fever, and urticaria. With the Indian antihistamine market seeing consistent growth driven by pollution, seasonal allergies, and lifestyle changes, distributors are keen on adding Levocetirizine to their product line.
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Product Overview:
- Composition: Levocetirizine Hydrochloride IP 5mg
- Dosage Form: Oral solid – Tablets
- Strength: Levocetirizine Hydrochloride IP 5mg per tablet
Therapeutic Uses:
- Relief from sneezing, runny nose, and itching
- Treatment of chronic urticaria
- Controls symptoms of allergic rhinitis and skin allergies
Regulatory Classification:
Requires physician supervision
Rx drug (Prescription-only)
Schedule H under the Indian Drugs and Cosmetics Act 1940 and Rules 1945.
Third-Party Manufacturing of Levocetirizine Hydrochloride Tablets IP 5mg Process
Here’s a step-by-step overview of the third party manufacturing process for Levocetirizine Hydrochloride Tablets IP 5mg:
Step-by-Step Workflow:
- Product Finalization
Choose tablet specifications, packaging style, and brand name. - Documentation Submission
- Drug License (Retail/Wholesale DL)
- GST Registration
- Company PAN Card
- Letter of Intent (LOI)
- Aadhaar and Authorization Letter
- Quotation & Order Confirmation
The manufacturer provides a box rate and MOQ (usually 500 boxes). - Artwork & Packaging Approval
Design of strip, monocarton, and outer box shared for approval. - Production & Testing
Batch manufacturing, in-process testing, and stability studies. - Dispatch & Billing
Final QC, invoice generation, and dispatch to the distributor’s address.
Role Division:
Marketing Company: Handles product branding, marketing, and distribution
Manufacturer: Ensures compliance, quality, and timely production
Quality & Compliance Considerations
To maintain credibility and regulatory compliance, manufacturers adhere to:
- WHO-GMP and ISO Certifications
- Stability Testing: Ensures shelf-life consistency
- Quality Parameters: Assay, uniformity of content, dissolution, etc.
- Packing Requirements:
- 10×10 blister/aluminium/aluminum-aluminum packs
- Clear labeling as per D&C Act with Rx symbol, Mfg/Exp, Batch No., etc.
Cost and Investment Breakdown
MOQ:
Minimum order quantity is usually 500 boxes (10×10 tablets).
Typical Costing Structure:
| Component | Approximate Cost per Box |
|---|---|
| Manufacturing Cost | ₹22 – ₹30 |
| Packing (monocarton, foil, box) | ₹4 – ₹6 |
| Quality Testing | ₹1 – ₹2 |
| Freight & Transport | ₹2 |
| GST (12%) | As applicable |
Estimated Cost Range per Box: ₹30 – ₹40
Cost Optimization Tips:
- Order in bulk to reduce unit cost
- Opt for standard packing designs
- Negotiate freight-inclusive rates
- Ask for combo deals (Levocetirizine + Montelukast)
Choosing the Right Manufacturer
Shortlisting Criteria:
- WHO-GMP, ISO Certified facility
- Experience in antiallergic drug manufacturing
- Transparent pricing & batch timelines
Key Questions to Ask:
- Do you provide a test COA (Certificate of Analysis)?
- What’s the batch turnaround time?
- Can you customize the packaging with our brand?
Red Flags to Avoid:
- No documentation trail
- Vague pricing
- Inconsistent lead times or no after-sales support
Marketing and Branding Strategy
In a crowded generic market, differentiation is key.
Packaging Tips:
- Use allergy-relief colors (blue/green tones)
- Highlight benefits like “Non-sedative”, “24-hr relief”
- Include a QR code for doctor information
Promotional Materials:
- Visual Aids for MRs
- MR bags & doctor pads
- Sample packs
- Digital brochures for WhatsApp marketing
Regulatory and Legal Compliance
- Labeling Requirements:
- Schedule H caution
- Rx symbol
- Mfg. details, Batch No., Expiry
- Pharmacovigilance:
- Maintain batch-wise records
- Handle any adverse reaction complaints
- Product Liability:
- Get product insurance if marketing under own brand
- Ensure proper indemnity clauses with the manufacturer
FAQs – Third Party Manufacturing of Levocetirizine Hydrochloride Tablets IP 5mg
1. What is the MOQ for Levocetirizine Hydrochloride Tablets IP 5mg?
The standard MOQ is 500 boxes (10×10).
2. What documents are required to start third-party manufacturing?
Drug License, GST, LOI, company details, and Aadhaar card.
3. How long does it take for manufacturing and dispatch?
20–25 working days from artwork approval.
4. Can I get customized packaging under my brand name?
Yes, most manufacturers allow full customization.
5. What is the current market price of Levocetirizine Hydrochloride Tablets IP 5mg?
MRP ranges between ₹30–₹50 per strip depending on brand positioning.
6. Are there combined formulations available like Levocetirizine + Montelukast?
Yes, many manufacturers offer combo packs on request.
7. Is Levocetirizine OTC or Rx?
It is an Rx drug – only available on prescription.
Call to Action
If you’re a pharma distributor or entrepreneur planning to enter the antiallergic segment, Levocetirizine Hydrochloride Tablets IP 5mg is a high-demand, low-risk molecule to begin with.
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Support in branding, designing, and regulatory documentation.
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