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.
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.
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.
The combination of Ceftriaxone Sodium and Sulbactam Sodium enhances the antimicrobial spectrum and effectiveness, especially against beta-lactamase-producing organisms.
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
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
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).
Cleanrooms are validated daily through:
Particle count monitoring
Air pressure differentials
Temperature and humidity logs
Microbial monitoring (settle plates, swabs)
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.
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.
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.
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.
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.
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.
Sterile rubber stoppers are partially inserted before lyophilization and sealed post-process using aluminum caps.
Flip-off seals are applied automatically.
Fill volume check
Sterility tests
pH and clarity
Moisture content (Karl Fischer method)
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.
Type I or II clear glass vials
Flip-off aluminum seals
Sterile rubber stoppers
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.
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
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.
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).
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
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.