The pharmaceutical third-party manufacturing model has revolutionized the way pharma businesses scale operations. It allows marketing companies and startups to launch products without investing in costly manufacturing units. Instead, they partner with WHO-GMP certified pharma manufacturers to produce high-quality medicines under their brand name.

One such product in high demand is Ofloxacin Tablets IP 200mg. A broad-spectrum antibiotic belonging to the fluoroquinolone class, Ofloxacin is widely prescribed for bacterial infections such as respiratory tract infections, urinary tract infections (UTIs), skin infections, and gastrointestinal infections. With India being one of the largest antibiotic-consuming markets, the demand for Ofloxacin Tablets remains steady in both government tenders and private markets.

Also Read this: Levocetirizine Hydrochloride Tablets IP 5mg

Product Overview: Ofloxacin Tablets IP 200mg

• Composition: Ofloxacin 200mg
• Dosage Form: Oral tablet
• Strength: 200mg

Therapeutic Use and Benefits of Ofloxacin Tablets IP 200mg:

• Effective in treating a wide range of bacterial infections
• Rapid action with good bioavailability
• Generally well-tolerated in adults

Regulatory Classification:

• Prescription Drug (Rx)
• Schedule H Drug under the Drugs and Cosmetics Act
• Must be sold on the prescription of a registered medical practitioner

Third-Party Manufacturing Process for Ofloxacin Tablets IP 200mg

Here is a step-by-step process for initiating third-party manufacturing:

1. Inquiry & Quotation

• Share product name, strength, packaging type, quantity (MOQ: 500 boxes)
• Receive a quotation with a cost breakup

2. Documentation Submission

Required documents:

• LOI (Letter of Intent)
• Drug License (Retail/Wholesale)
• GST Number
• Company PAN
• Cancelled cheque (for billing)

3. Finalization of Product Details

• Confirmation of packaging design, artwork, and brand name
• Approval of label claims and statutory details

4. Production Process

• Procurement of raw material
• In-house testing of the API
• Tablet compression, coating, and packaging

5. Testing & Quality Checks

• In-process and finished product testing
• Generation of COA (Certificate of Analysis)

6. Dispatch

• Goods are shipped via transporter or courier
• Invoice, COA, and Batch Release Certificate provided

Quality & Compliance Considerations

When choosing a manufacturer for Ofloxacin Tablets IP 200mg contract manufacturing, ensure the following:

• Certifications: GMP, ISO 9001:2015
• Stability Testing: As per ICH guidelines
• Testing Parameters:
  • Uniformity of weight
  • Disintegration time
  • Assay & dissolution
  • Microbial contamination check

Packaging & Labeling

• Blister or Alu-Alu standard packaging
• The label should include:
  • Brand name, generic name
  • Batch No.., Mfg. Date, Exp. Date
  • Schedule warning, Rx symbol
  • The manufacturer’s and marketer’s names with address

Cost and Investment Breakdown

MOQ: 500 boxes (10×10 tablets per box)

Typical Cost Structure (Indicative):

• Manufacturing: ₹0.70 – ₹0.90 per tablet
• Packing Material: ₹10 – ₹15 per box
• Freight: ₹0.50 per box (varies by location)
• Testing & COA: Included in price
• GST: 12% applicable

Tips to Optimize Cost:

• Order larger quantities for better price breaks
• Use standard packaging materials
• Select manufacturers close to your region to reduce freight costs

Choosing the Right Manufacturer

Shortlisting Vendors

• Look for manufacturers with:
  • WHO-GMP & ISO certification
  • Minimum 5 years of antibiotic manufacturing experience
  • In-house quality control labs

Questions to Ask

• What is the turnaround time for Ofloxacin Tablets IP 200mg?
• Can they support with promotional material?
• Do they offer third-party stability data?

Red Flags to Avoid

• No online presence or GST number
• Delayed documentation
• Lack of batch traceability or COA

Marketing and Branding Strategy

Packaging

• Use unique color schemes and minimalist design
• Include doctor-friendly information on the box

Promotional Ideas

• MR Bags
• Visual Aids (highlighting benefits of Ofloxacin 200mg)
• Product cards with QR codes linking to your website
• Free samples for doctors

Regulatory and Legal Compliance

• Follow labeling norms as per Schedule H regulations
• Ensure all products include statutory declarations:
  • “To be sold by retail on the prescription of a Registered Medical Practitioner only”
• Maintain proper documentation for pharmacovigilance
• Monitor and report adverse drug reactions if any arise

FAQs