Third-party manufacturing allows pharma marketing companies to get products manufactured under their brand name by a licensed manufacturer. This model reduces infrastructure investment and helps companies focus on marketing and distribution.

Rabeprazole Sodium (EC) & Levosulpiride (SR) Capsules is a commonly manufactured product in this model. It falls under the gastroenterology segment and is used in the treatment of acid reflux, dyspepsia, and functional gastrointestinal disorders. Due to regular demand from physicians, this product is frequently manufactured by third-party vendors.

Also Read this: Pantoprazole and Domperidone SR Capsules

Product Overview of Rabeprazole Sodium (EC) & Levosulpiride (SR) Capsules:

• Composition: Rabeprazole Sodium 20mg (Enteric-Coated) + Levosulpiride 75mg (Sustained Release)
• Dosage Form: Capsules
• Regulatory Status: Rx only, Schedule H drug

Uses of Rabeprazole Sodium (EC) & Levosulpiride (SR) Capsules:

• Rabeprazole: Proton pump inhibitor used for acid control
• Levosulpiride: Prokinetic agent for symptoms like bloating, early satiety, and indigestion

This fixed-dose combination addresses both acid-related and motility-related symptoms.

Third-Party Manufacturing Process:

Process Steps

1. Product inquiry – Define composition and quantity
2. Quotation – Manufacturer provides cost per unit with packaging options
3. Documentation – Submit:
   • Drug License
   • GST certificate
   • LOI (Letter of Intent)
   • PAN & Aadhaar (for KYC)
4. Approval – Finalize artwork, brand name, and packing material
5. Production – Manufacturer handles batch manufacturing
6. Dispatch – Product is tested and shipped with required documentation

Roles of Manufacturer and Marketing company

• Manufacturer: Handles production and quality control
• Marketing Company: Manages brand, pricing, and distribution

Quality and Compliance

For Rabeprazole Sodium (EC) & Levosulpiride (SR) Capsules, the following apply:

• Certifications: Minimum GMP or ISO preferred
• Testing: Assay, content uniformity, dissolution, and SR/EC profile
• Stability: Basic stability testing before and during shelf life
• Packaging: Alu-Alu or blister, compliant with labeling norms (Schedule H warning, Mfg/Exp dates, Batch No.)

Cost and Investment

• Minimum Order Quantity (MOQ): 500 boxes (10x10s)
• Estimated Cost Breakdown:
  • Manufacturing: ₹11–₹20 per strip
  • Packing Material: ₹1–₹1.5 per strip
  • Testing/Documentation: ₹0.5–₹1
  • Freight: ₹1
  • GST: 12%

Approximate cost per strip: ₹11–₹12, depending on vendor and packaging type

Cost Control Tips:

• Use standard packaging to minimizing the cost
• Plan higher quantities per order
• Avoid frequent design changes

Selecting a Manufacturer

How to Evaluate:

• Check plant approvals (cGMP, WHO-GMP)
• Review client references or the existing brand portfolio
• Ensure prompt documentation and delivery timelines

Key Questions:

• What is your typical lead time?
• Is packing material included in the cost?
• Are stability reports available?

Avoid

• Unclear pricing terms
• Delayed dispatch without updates
• Poor packaging compliance

Branding and Marketing

Although manufacturing is outsourced, product presentation impacts recall.

• Use clear packaging with readable fonts
• Ensure required warnings and brand details
• Keep MR promotional tools basic: visual aids, doctor samples, detailing cards

Regulatory Compliance

• Label must include Schedule H warning and statutory info
• Pharmacovigilance (AE/ADR reporting) is required for Rx products
• Avoid unapproved therapeutic claims on cartons or visual aids

FAQs – Rabeprazole Sodium (EC) & Levosulpiride (SR) Capsules