Manufacturer of Ceftriaxone Sodium and Sulbactam Sodium Injection in India
                     rklifecare.co
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INTRODUCTION 
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.
What is Ceftriaxone UNDERSTANDING 
SCoeftdriaixuomne i?s a third-generation 
cephalosporin antibiotic with broad-
spectrum bactericidal activity. It works by CEFTRIAXONE AND 
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 
COMBINATION
 What is Sulbactam Why the Combination?
Sodium?
Sulbactam is a β-lactamase inhibitor The combination of Ceftriaxone 
that enhances the efficacy of beta- Sodium and Sulbactam Sodium 
lactam antibiotics like Ceftriaxone. enhances the antimicrobial 
Sulbactam does not have significant 
spectrum and effectiveness, 
antibacterial activity alone but 
prevents the degradation of especially against beta-
Ceftriaxone by resistant bacteria lactamase-producing organisms.
About R K Lifecare INC – 
Experience and Expertise
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
ACTIVE 
PHARMACEUTICAL 
TIhNe APGIs—RCefEtriaDxonIe ESodNiumT anSd S u(lbaActaPm SIoSdium)—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
EXCIPIENTS AND PACKAGING 
MOtAheTrE mRaItAeLrials like sterile water, rubber 
stoppers, flip-off seals, and glass vials are also 
sourced from trusted vendors who meet 
pharmacopeial standards (USP/BP/IP).
MANUFACTURING PROCESS – 
AUTHORITATIVE TECHNICAL BREAKDOWN
Environmental 
Monitoring:
Cleanrooms are validated daily through:
• Particle count monitoring
• Air pressure differentials
• Temperature and humidity logs
• Microbial monitoring (settle plates, swabs)
Our infrastructure 
includes:
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.
Weighing and 
01 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.
Solution 
Step-by-Step 02
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.
Manufacturing of Bulk Solution 
03 SterilizationCeftriaxone and • 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.
Sulbactam Aseptic 
Injection 04
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.
Lyophilization (Freeze 
05 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.
Company 
06 Background• Sterile rubber stoppers are partially inserted before lyophilization and sealed post-process using aluminum caps.
• Flip-off seals are applied automatically.
IN-PROCESS 
AND FINAL QC 
TESTING
In-process Tests Final Release 
Include: T•eAsstasy :by HPLC
• Related substances
• Fill volume check • Reconstitution time
• Sterility tests • Particulate matter
• pH and clarity • Bacterial Endotoxin Test (BET)
• Moisture content (Karl Fischer • Container closure integrity
method)
Each batch is released only after QA review 
and QC clearance.
Packaging and 
Labeling
 Primary Packaging
• Type I or II clear glass vials
• Flip-off aluminum seals
• Sterile rubber stoppers
Our infrastructure 
includes:
• 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.
Regulatory 
Compliance and 
ADt R Ko Lifeccarue INmC, we uephonld retgualatorty eixcoellence 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
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.
Export and Supply 
Chain 
RM K Liafecanre IaNC. gservees mover 2e0+n coutntries 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).
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
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