In the evolving Indian pharmaceutical landscape, third party manufacturing has emerged as a cost-effective and scalable business model, allowing marketing companies and startups to launch their own brand of medicines without investing in manufacturing infrastructure.
Among the top-trending antibiotics today is Azithromycin Tablets IP 500mg, a macrolide class antibiotic widely prescribed for respiratory infections, skin infections, and STDs. Owing to its broad-spectrum effectiveness and relatively low side-effect profile, the demand for Azithromycin 500mg remains strong in both domestic and export markets.
According to industry data, the Indian azithromycin market has witnessed steady growth, valued at over ₹400 crores annually, especially during flu seasons and post-COVID scenarios, making it a lucrative product for third party or contract manufacturing ventures.
Also Read: Azithromycin Tablets IP 250mg
Product Overview
- Composition: Azithromycin IP 500mg
- Dosage Form: Tablets
- Strength: 500mg
Therapeutic Use of Azithromycin Tablets IP 500mg:
Azithromycin is used to treat a wide variety of bacterial infections, including:
- Upper and lower respiratory tract infections (like pharyngitis, bronchitis)
- Skin and soft tissue infections
- Urogenital infections
- Typhoid fever (in some cases)
Benefits of Azithromycin Tablets IP 500mg:
- Once-daily 500mg
- Short treatment course
- High patient compliance
- Broad-spectrum antimicrobial action
Regulatory Classification:
- Rx Drug: Prescription only
- Schedule H: Under the Drugs and Cosmetics Act, 1940
- Export-friendly: Widely accepted in ROW and semi-regulated markets
Third-Party Manufacturing Process for Azithromycin Tablets IP 500mg
Step-by-Step Process:
- Product Finalization: Choose Azithromycin Tablets IP 500mg with required specifications.
- Manufacturer Shortlisting: Find GMP-certified contract manufacturers.
- Quotation & MOQ Agreement: Typically, MOQ is 500 boxes (10×3 tablets).
- Documentation Submission:
- Drug License (Form 20B & 21B)
- GST Registration
- LOI (Letter of Intent)
- Company PAN & Aadhaar
- Artwork Design & Approval: Brand name, label design, foil details, carton layout.
- Manufacturing & QA Checks: BMR, BPR, QC, and QA release as per GMP norms.
- Dispatch & Billing: Product is packed, labeled, and shipped via authorized transporter.
Roles:
- Manufacturer: Handles procurement, production, testing, and packing.
- Marketing Company: Owns the brand, handles promotion, and distribution.
Quality & Compliance Considerations
Azithromycin, being a critical antibiotic, must meet high quality and compliance standards:
- cGMP Compliance: Manufacturing in a WHO-GMP approved facility
- ISO Certification: ISO 9001 or ISO 22000 recommended
- Testing Parameters: Assay, dissolution, related substances, stability
- Stability Studies: Real-time and accelerated stability under ICH guidelines
- Labeling Requirements:
- Schedule H warning
- Storage conditions
- Batch number, Mfg/Exp dates
Packaging must be tamper-evident, moisture-resistant, and clearly labeled as per D&C Act.
Cost and Investment Breakdown
MOQ:
500 boxes (10×3 tablets)
Cost Structure (Indicative) of Azithromycin Tablets IP 500mg:
| Component | Cost Range (per box) |
|---|---|
| Manufacturing | ₹190 – ₹200 |
| Packing Material | ₹10 – ₹12 |
| Freight & Forwarding | ₹1.50 – ₹2 |
| Testing Charges | ₹0.50 – ₹1 |
| GST (12%) | As applicable |
Total Estimated Cost: ₹210 – ₹220 per tablet (Approx.)
Tips for Cost Optimization:
- Choose bulk MOQ (1000+ boxes)
- Standardize carton & foil layout for future batches
- Negotiate the packing design templates upfront
Choosing the Right Manufacturer
How to Shortlist Vendors:
- WHO-GMP/GLP certification
- Years of experience in antibiotic manufacturing
- Timely delivery record
Questions to Ask:
- Do you offer stability data and COA?
- What is the batch release timeline?
- Can you help with packaging design?
Red Flags:
- No documentation support
- Inconsistent pricing
- Lack of regulatory approvals
Marketing and Branding Strategy
Packaging Tips:
- Use bold branding with distinctive colors
- Include QR codes for authenticity
- Use aluminum-aluminum blister for a premium look
Promotional Material Ideas:
- Visual aids for doctors
- MR bags with logo
- Sample kits for product trials
Make sure your packaging stands out in the crowded Azithromycin segment.
Regulatory and Legal Compliance
- Label Claims: Must not suggest a cure for viral infections or non-indicated use
- Declarations: Schedule H warning, MRP, batch details, and mfg address
- Pharmacovigilance: Adverse reaction tracking and customer complaints must be documented
Frequently Asked Questions (FAQs)
1. What is the MOQ for third party manufacturing of Azithromycin Tablets IP 500mg?
Usually, it’s 500 boxes (10×3 tablets per box).
2. Can I manufacture under my brand name?
Yes, with a valid Drug License and GST registration.
3. What documents are required to start?
LOI, Drug License copy, GST certificate, and company PAN/Aadhaar.
4. What is the shelf life of Azithromycin 500mg tablets?
Typically 24 to 36 months depending on formulation and packaging.
5. How can I differentiate my brand in the market?
Focus on packaging design, doctor engagement, and sample distribution.
6. Can I export Azithromycin Tablets manufactured through a third party?
Yes, provided the manufacturer holds export licenses and complies with destination country norms.
7. What is the current price of Azithromycin Tablets IP 500mg?
It varies from ₹27 to ₹33 per box depending on quantity and specifications.
