Third-party manufacturing is a practical model in the pharmaceutical industry, especially for marketing companies and distributors without manufacturing facilities. It allows businesses to get products manufactured under their brand name by partnering with licensed manufacturers.

Omeprazole and Domperidone Capsules IP is a commonly prescribed combination used in the treatment of acid reflux, gastritis, and indigestion. This product belongs to the gastrointestinal drug segment, which continues to see regular demand in both domestic and hospital markets.

Also Read this: Rabeprazole Sodium (EC) and Levosulpiride (SR) Capsules.

Product Overview of Omeprazole and Domperidone Capsules IP:

• Composition: Omeprazole 20mg + Domperidone 10mg
• Dosage Form: Capsules
• Regulatory Status: Schedule H, Prescription-only (Rx) drug
• Therapeutic Use: Used for managing GERD, nausea, functional dyspepsia, and other gastric discomforts

This combination works by reducing acid production and promoting better stomach emptying. It is included in standard treatment guidelines for gastric issues.

Third-Party Manufacturing Process

Step-by-Step Workflow:

1. Product Inquiry: Submit the required product details to the manufacturer.
2. Quotation: Manufacturer shares price, packaging options, and lead time.
3. Documents Required:
   • Drug License (Form 20B & 21B)
   • GST Registration
   • PAN and Address Proof
   • Letter of Intent (LOI)
4. Artwork and Packaging Finalization
5. Production and Quality Control
6. Testing and Batch Release
7. Dispatch with COA and Invoice

Roles:

• Manufacturer handles formulation, production, QA/QC, and dispatch.
• Marketing company manages brand promotion, distribution, and sales.

Quality and Compliance

• Standards Followed: cGMP, WHO-GMP, ISO 9001
• Testing Parameters: Assay, dissolution, stability, moisture content
• Packaging Requirements:
  • Schedule H declaration
  • Batch number, expiry, manufacturing date, and MRP
  • Packaging must follow Drugs and Cosmetics Act guidelines

Cost and Investment of Omeprazole and Domperidone Capsules IP:

• Minimum Order Quantity (MOQ): Usually starts at 500 boxes
• Typical Cost Components:
  • Product manufacturing: ₹0.40–₹0.55 per capsule
  • Packing material: ₹1.50–₹2.00 per strip
  • Freight charges: Varies by region
  • Testing/Analysis: ₹2,000–₹3,000 per batch
  • GST: 12%

Cost-Saving Tips:

• Order higher volumes for price negotiation
• Standardize artwork across batches
• Plan dispatch frequency to minimize freight charges

Choosing a Reliable Manufacturer

Shortlisting Tips:

• Ensure WHO-GMP and state FDA approval
• Review the documentation process and client references
• Prefer companies with experience in GI products

Questions to Ask:

• What is the standard lead time?
• Are all quality reports provided with each batch?
• Can I visit the facility or get proof of video?

Caution Signs:

• No written commitments
• Delayed responses or pricing without GST breakup
• Lack of in-house testing support

Branding and Promotion Strategy

• Packaging: Keep it simple and readable. Use neutral colors with dosage clarity.
• Promotional Materials:
  • Visual aids for doctors
  • Product cards or sample strips
  • MR bags with company branding

These tools can help in initial product visibility but should be aligned with local marketing practices and regulations.

Regulatory Compliance

• Label Requirements:
  • Composition, Schedule H warning, expiry, batch number, and license number
• Adverse Reaction Reporting: A Basic pharmacovigilance setup is recommended
• Liability: Product liability remains with the marketing company once goods are sold

Frequently Asked Questions (FAQs):