Pantoprazole Gastro-Resistant Tablets IP belong to the category of Proton Pump Inhibitors (PPIs), primarily used in the treatment of gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. The active ingredient Pantoprazole works by reducing the amount of acid produced in the stomach, offering effective relief to patients suffering from chronic acidity and related disorders.
In recent years, Pantoprazole Gastro-Resistant Tablets IP have witnessed a consistent surge in demand due to the rising prevalence of gastrointestinal issues globally. The Indian market alone sees a multi-crore turnover in the PPI category. For pharma entrepreneurs, opting for third party manufacturing of Pantoprazole Gastro-Resistant Tablets IP is a more cost-effective, scalable, and quality-assured strategy compared to stocking or promoting existing PCD brands.
Also read this: Pantoprazole and Domperidone Tablets
Product Overview: Pantoprazole Gastro-Resistant Tablets IP 40mg
- Composition: Pantoprazole Sodium Sesquihydrate equivalent to Pantoprazole 40mg
- Dosage Form: Gastro-resistant tablets
- Strength: 40mg
- Uses:
- Treatment of acid reflux
- Healing of erosive esophagitis
- Preventive care in long-term NSAID therapy
- Regulatory Status:
- Rx Drug (Prescription required)
- Falls under Schedule H as per Drugs and Cosmetics Act, India
Third Party Manufacturing Process: Step-by-Step
Here’s how the third-party manufacturing of Pantoprazole Gastro-Resistant Tablets IP unfolds:
- Inquiry & Quotation: Choose a reliable manufacturer and request a quote.
- Finalize Composition: Confirm strength, dosage, and packaging preferences.
- Documentation Submission:
- LOI (Letter of Intent)
- Drug License (Form 20B & 21B)
- GST Number
- Company PAN and Aadhaar
- Packaging Material Design: Share brand name, logo, and packaging preferences.
- Approval & Manufacturing: Manufacturer processes raw material, conducts trials, and completes batch production under GMP conditions.
- Quality Checks & Testing: In-house and third-party lab testing with COA (Certificate of Analysis).
- Dispatch & Logistics: Final dispatch to the distributor/entrepreneur’s address.
Quality & Compliance Considerations
- Compliance Certifications:
- cGMP certified units
- ISO 9001:2015 compliance
- Quality Testing:
- Assay, disintegration, dissolution, and stability testing
- Stability: Minimum 24 months shelf life
- Packaging & Labeling:
- Mention Schedule H Warning: “To be sold by retail on the prescription of a Registered Medical Practitioner only.”
- Batch no., manufacturing & expiry dates, manufacturing license number must be mentioned
- Packing Options:
- Alu-Alu in cartons of 10×10 tablets
Cost and Investment Breakdown
- MOQ: 500 boxes (10×10 tablets/box)
- Typical Costing:
- Manufacturing: ₹6.5 – ₹7 per strip
- Packing: ₹1.50 – ₹2.00 per strip
- Testing & QC: ₹0.50 – ₹1.00 per strip
- GST (12%): Applied on total invoice
- Freight: As per actuals or negotiable
Tips for Cost Optimization:
- Order in higher quantities to leverage bulk discounts
- Opt for Alu-Alu packing for premium positioning
- Negotiate freight rates with logistics partners
Choosing the Right Manufacturer
Checklist to shortlist a reliable manufacturer:
- WHO-GMP and ISO certifications
- Good past client reviews
- Specialization in gastro products
Questions to Ask:
- What is the lead time per batch?
- Are there additional charges for packing material design?
- Do you provide product samples before final dispatch?
Red Flags:
- No transparency in costing
- Delayed communication
- Absence of quality testing reports
Marketing and Branding Strategy
- Packaging Differentiation: Use clean, modern design with Pantone colors
- Promotional Materials:
- MR Visual Aids
- Product Cards
- Doctor Reminder Pads
- MR Bags branded with the product name
- Brand Identity: Register a trademark for the brand name to build a trusted pharma label
Regulatory and Legal Compliance
- Ensure label claims match DCGI-approved text
- Include statutory declarations (Schedule H)
- Keep pharmacovigilance process in place
- Maintain batch recall procedures to manage product liability
FAQs– Pantoprazole Gastro-Resistant Tablets IP:
1. What is the MOQ for third-party manufacturing of Pantoprazole Gastro-Resistant Tablets IP?
Minimum 500 boxes (10×10 tablets) is standard.
2. What documents are needed for third-party manufacturing?
LOI, Drug License, GST registration, PAN, and Aadhaar of the company.
3. Is Pantoprazole 40mg a prescription drug?
Yes, it falls under Schedule H and requires a prescription.
4. How long does it take to manufacture and dispatch the product?
Generally, 25–30 working days after approval of packaging.
5. Can I use my own brand name?
Yes, you can get your own brand printed and registered.
6. Is product testing included in the manufacturing cost?
Testing charges are either included or billed separately. Confirm with manufacturer.
7. Can I order both Alu-Alu and Blister packing options?
Yes, subject to MOQ and packaging cost differences.
