The third-party manufacturing model allows pharmaceutical companies to outsource production to licensed manufacturers. This model is suitable for marketers who want to launch products without owning a production facility.
Pantoprazole and Domperidone Tablets are commonly used in the treatment of acid reflux and gastrointestinal disorders. This combination belongs to the gastroenterology category and has steady demand in the Indian pharmaceutical market.
Also read this:- Pantoprazole and Domperidone SR Capsules.
Product Overview of Pantoprazole and Domperidone Tablets:
- Composition: Pantoprazole 40mg + Domperidone 10mg
- Dosage Form: Tablets
- Strengths: Pantoprazole 40mg + Domperidone 10mg
Uses and Regulatory Status:
- Used for treating acid reflux, GERD, and nausea
- Requires prescription (Rx)
- Classified under Schedule H of the Drugs and Cosmetics Act
Third-Party Manufacturing Process
- Inquiry: Share product details with a manufacturer and request pricing.
- Composition Finalization: Confirm formulation and packaging style.
- Documentation:
- Drug License
- GST Registration
- PAN and Aadhar
- Letter of Intent (LOI)
- Agreement: Finalize terms and sign a manufacturing agreement.
- Production: The Manufacturer proceeds with batch production and testing.
- Dispatch: Goods are packed and shipped.
Roles:
- The manufacturer handles production, testing, and packaging.
- A marketing company manages branding and distribution.
Quality & Compliance
- Facilities should follow cGMP and ISO standards
- Testing includes stability, dissolution, and microbial analysis
- Packaging must meet legal and quality norms
- Labeling should display all regulatory details
Cost and Investment
- MOQ: 500 boxes (10×10 tablets each)
- Costing Structure:
- Manufacturing: INR 6.5 – 7.00 per strip
- Packing: INR 1.00 – 1.50 per strip
- Additional: Freight, testing, GST @12%
Cost Control Tips:
- Larger quantities reduce per-strip cost
- Standardize packaging materials
Choosing a Manufacturer
Selection Criteria:
- Check certifications and track record
- Review manufacturing capacity and timelines
Questions to Ask:
- Do you provide COA and stability data?
- What is your lead time?
Red Flags:
- Incomplete documentation
- Poor communication
Marketing and Branding
- Packaging should clearly present product information
- Promotional materials may include MR bags, visuals, and prescription pads
Regulatory Considerations
- Labels must meet DPCO and CDSCO rules
- Include statutory declarations like Schedule H warning
- Set up systems for post-market safety monitoring
FAQs – Pantoprazole and Domperidone Tablets:
1. What is the MOQ for Pantoprazole and Domperidone Tablets?
Generally, 500 boxes.
2. What documents are needed?
Drug License, GST, PAN, Aadhar, LOI.
3. How long is the manufacturing cycle?
Typically 30-35 days.
4. What is the per strip price?
Around INR 7, based on requirements.
5. Can I use my brand name?
Yes, branding is customizable.
6. Are stability reports provided?
Yes, if requested.
7. Do manufacturers provide promotional material?
Some may provide design or samples.
