Manufacturer of Ceftriaxone Sodium and Sulbactam Sodium Injection in India

India is one of the global leaders in the pharmaceutical industry, known for its robust manufacturing infrastructure, skilled workforce, and high-quality injectable products. Among the front-runners is R K Lifecare INC, a GMP-WHO-certified manufacturing facility based in Jhajjar, Haryana. The company is a reliable name in both human and veterinary injectables, especially known for its expertise in manufacturing dry powder injections such as Ceftriaxone Sodium and Sulbactam Sodium for Injection.

Section 1: Understanding Ceftriaxone and Sulbactam Combination

1.1 What is Ceftriaxone Sodium?

Ceftriaxone is a third-generation cephalosporin antibiotic with broad-spectrum bactericidal activity. It works by inhibiting bacterial cell wall synthesis. It is commonly used in the treatment of respiratory tract infections, intra-abdominal infections, meningitis, skin infections, and urinary tract infections.

1.2 What is Sulbactam Sodium?

Sulbactam is a β-lactamase inhibitor that enhances the efficacy of beta-lactam antibiotics like Ceftriaxone. Sulbactam does not have significant antibacterial activity alone but prevents the degradation of Ceftriaxone by resistant bacteria.

1.3 Why the Combination?

The combination of Ceftriaxone Sodium and Sulbactam Sodium enhances the antimicrobial spectrum and effectiveness, especially against beta-lactamase-producing organisms.

Section 2: About R K Lifecare INC – Experience and Expertise

2.1 Company Background

With a legacy rooted in innovation and compliance, R K Lifecare INC has over a decade of experience in manufacturing a diverse range of injectables. We specialize in dry powder injections, catering to both the domestic Indian market and overseas clients in Africa, Southeast Asia, and Latin America.

Our infrastructure includes:

• WHO-GMP certified manufacturing plant

• ISO 9001:2015 certification

• Dedicated cleanroom facilities (Class 1000 to 100,000)

• In-house microbiology and chemical labs

• Skilled pharmacists, chemists, and QA/QC personnel

Section 3: Raw Material Procurement – Building Trust Through Quality

3.1 Active Pharmaceutical Ingredients (APIs)

The APIs—Ceftriaxone Sodium and Sulbactam Sodium—are procured from certified and audited vendors who comply with ICH-GMP standards. Every batch of API is subjected to:

• COA Verification (Certificate of Analysis)

• Identity testing (FTIR, UV, HPLC)

• Impurity profiling

• Microbial limits test

3.2 Excipients and Packaging Material

Other materials like sterile water, rubber stoppers, flip-off seals, and glass vials are also sourced from trusted vendors who meet pharmacopeial standards (USP/BP/IP).

Section 4: Manufacturing Process – Authoritative Technical Breakdown

4.1 Pre-Manufacturing Activities

a. Environmental Monitoring:

Cleanrooms are validated daily through:

• Particle count monitoring

• Air pressure differentials

• Temperature and humidity logs

• Microbial monitoring (settle plates, swabs)

b. Equipment Sanitization:

All mixing vessels, filling machines, and lyophilizers are sanitized and validated. Autoclaving and dry-heat sterilization are used for parts in contact with sterile products.

4.2 Step-by-Step Manufacturing of Ceftriaxone and Sulbactam Injection

Step 1: Weighing and Dispensing

• API and excipients are weighed in a separate Class 10000 area.

• Weighing is done on calibrated digital balances under laminar air flow (LAF) to prevent cross-contamination.

Step 2: Solution Preparation

• Ceftriaxone and Sulbactam are dissolved in Water for Injection (WFI) in separate SS316 reactors under controlled temperature and pH conditions.

• Solution pH is adjusted and filtered through 0.2-micron filters.

Step 3: Bulk Solution Sterilization

• The filtered solution is passed through a double 0.22-micron membrane filter.

• Sterility is ensured using a closed-loop filtration system with nitrogen blanketing.

Step 4: Aseptic Filling

• The sterile solution is filled into sterilized glass vials in Class 100 cleanrooms.

• Filling is done using peristaltic pumps for consistent volume accuracy.

• Inert nitrogen is flushed into the headspace before sealing.

Step 5: Lyophilization (Freeze Drying)

• The vials are loaded into lyophilizers where the solution is frozen and then sublimated under vacuum.

• The freeze-drying cycle is pre-validated to ensure correct cake structure and moisture content.

Step 6: Rubber Stoppering and Sealing

• Sterile rubber stoppers are partially inserted before lyophilization and sealed post-process using aluminum caps.

• Flip-off seals are applied automatically.

4.3 In-Process and Final QC Testing

In-process Tests Include:

• Fill volume check

• Sterility tests

• pH and clarity

• Moisture content (Karl Fischer method)

Final Release Tests:

• Assay by HPLC

• Related substances

• Reconstitution time

• Particulate matter

• Bacterial Endotoxin Test (BET)

• Container closure integrity

Each batch is released only after QA review and QC clearance.

Section 5: Packaging and Labeling

5.1 Primary Packaging

• Type I or II clear glass vials

• Flip-off aluminum seals

• Sterile rubber stoppers

5.2 Secondary Packaging

• Printed cartons with product information, batch number, expiry date, and barcodes

• Product inserts (if required)

• Tamper-evident shrink sleeves (optional)

Packaging is done in humidity-controlled areas to maintain product integrity.

Section 6: Regulatory Compliance and Documentation

At R K Lifecare INC, we uphold regulatory excellence by complying with:

• WHO-GMP Guidelines

• Indian Drugs & Cosmetics Act

• Schedule M standards

• 21 CFR Part 210 & 211 (for export)

We maintain:

• Master Formula Records (MFR)

• Batch Manufacturing Records (BMR)

• Equipment Qualification (IQ, OQ, PQ)

• Annual Product Reviews (APR)

• Deviations and CAPA logs

Section 7: Stability Studies and Shelf Life

We conduct:

• Accelerated stability studies at 40°C/75% RH

• Long-term stability at 25°C/60% RH

• Zone IVb studies (for hot/humid countries)

Stability protocols ensure that the combination maintains potency, sterility, and clarity throughout the shelf life.

Section 8: Export and Supply Chain Management

R K Lifecare INC serves over 20+ countries with a strong supply chain. All exports are backed by:

• COPP (Certificate of Pharmaceutical Product)

• COA (Certificate of Analysis)

• MSDS (Material Safety Data Sheet)

• Stability Data (as per ICH Guidelines)

Products are shipped in temperature-controlled vans and handled as per GDP (Good Distribution Practices).

Section 9: Why Choose R K Lifecare INC? (Trustworthiness)

• Decade-Long Industry Experience

• GMP and ISO Certified Facility

• End-to-End In-House Testing

• Transparent Documentation & Audits

• Customer-Centric B2B Approach

• Track Record of Zero Major Regulatory Findings

Conclusion

The manufacturing of Ceftriaxone Sodium and Sulbactam Sodium Injection is a complex process that demands high-level expertise, sterile infrastructure, and stringent quality protocols. At R K Lifecare INC, we follow industry-best practices to ensure that every vial we produce is safe, effective, and regulatory compliant. With our in-depth technical know-how and consistent delivery record, we proudly stand among India’s leading dry injection manufacturers.

Whether you are a pharma distributor, hospital buyer, or regulatory authority, you can place your trust in R K Lifecare INC for world-class injectables that meet global standards.