Imipenem & Cilastatin

In the landscape of modern antimicrobial therapy, combating multidrug-resistant infections has become a top priority for global healthcare systems. Among the most potent options available for serious and life-threatening infections is the combination of Imipenem and Cilastatin. This highly effective beta-lactam antibiotic blend is reserved for critical infections, especially those caused by resistant Gram-positive and Gram-negative bacteria.

BluepillExpress, a globally recognized pharmaceutical manufacturer and exporter, proudly offers end-to-end third-party manufacturing solutions for Imipenem & Cilastatin formulations, including sterile injectables, supported by cutting-edge infrastructure, WHO-GMP certification, and rigorous quality assurance systems. With our international reach and customized services, we enable pharmaceutical brands, distributors, and healthcare institutions to deliver reliable treatment options for severe bacterial infections.

About BluepillExpress

BluepillExpress is a certified pharmaceutical manufacturer and global exporter based in India, with a presence across 30+ countries. Our capabilities span prescription drugs, specialty antibiotics, injectables, and critical care formulations. As a third-party manufacturing partner, we offer:

• WHO-GMP certified production facilities
• ISO 9001:2015 and FSSAI certified units
• In-house R&D and formulation development
• Regulatory documentation and export compliance
• Private labeling and custom packaging
• Timely production and delivery with scalable capacity

We specialize in manufacturing sterile injectables, including complex antibiotic combinations such as Imipenem and Cilastatin, used extensively in hospitals and ICUs.

Product Overview: Imipenem & Cilastatin

Imipenem is a broad-spectrum carbapenem antibiotic effective against a wide range of aerobic and anaerobic, Gram-positive and Gram-negative bacteria. It is highly resistant to beta-lactamases, making it effective against multidrug-resistant organisms. However, Imipenem is rapidly degraded in the kidneys by the enzyme dehydropeptidase I.

To counter this, Cilastatin, a specific renal dehydropeptidase inhibitor, is co-administered. It prevents the inactivation of Imipenem, thereby increasing its efficacy and plasma half-life.

Composition

• Imipenem (as monohydrate): Typically available in 250 mg, 500 mg, or 1 g dosage strengths
• Cilastatin (as sodium): Co-formulated in an equivalent dose ratio (e.g., 250 mg, 500 mg, or 1 g)

Pharmacological Classification:
Beta-lactam Antibiotic – Carbapenem class
Dehydropeptidase I Inhibitor

Mechanism of Action

• Imipenem inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell death.
• Cilastatin inhibits dehydropeptidase I in the renal tubule, preventing hydrolysis of imipenem, thus ensuring higher therapeutic levels in the body.

Therapeutic Indications

Imipenem & Cilastatin is indicated in the treatment of moderate to severe infections, including:

• Lower Respiratory Tract Infections (e.g., hospital-acquired pneumonia, ventilator-associated pneumonia)
• Intra-abdominal Infections (e.g., peritonitis, abscesses)
• Septicemia and Bacteremia
• Urinary Tract Infections (complicated)
• Skin and Soft Tissue Infections
• Bone and Joint Infections
• Gynecological Infections
• Post-operative Infections
• Multidrug-resistant bacterial infections

Dosage and Administration

• Administered via intravenous (IV) infusion
• Dosage depends on the severity of the infection, renal function, and the body weight of the patient
• Infusion typically administered over 20–60 minutes
• Must be reconstituted with suitable sterile diluents before administration
• Renal dose adjustments are required for impaired kidney function

Manufacturing Strengths at BluepillExpress

BluepillExpress offers sterile injectable manufacturing of Imipenem & Cilastatin under fully compliant, validated conditions designed for critical care formulations:

• Aseptic Manufacturing Zones: Cleanroom environment with Class 100/Grade A laminar flow
• Fully Automated Vial Filling and Sealing Machines
• Sterile Lyophilization (Freeze Drying) technology for powder-based injectables
• Controlled Environment: HEPA-filtered air, humidity and temperature regulation
• Sterilization Equipment: Autoclaves, sterilizing tunnels, vial washing units
• Batch Production Records: Digitally monitored, traceable, and compliant with cGMP

Packaging Solutions

We provide customizable packaging options tailored to regulatory and commercial preferences across different markets:

• Glass Vials (Type I Borosilicate) – 10 ml, 20 ml capacities
• Flip-off or Tear-off Aluminum Seals
• Sterile Water for Injection (optional ampoule/vial)
• Outer Monocarton Packaging
• Multilingual and Regulatory-Compliant Labeling
• Tamper-evident, barcoded packaging available for institutional supply

Product Stability and Shelf Life

Our lyophilized injectable formulations are validated for extended shelf life and storage stability:

• Storage Conditions: Between 2°C to 8°C or at room temperature (as per final formulation)
• Shelf Life: 18 to 24 months under specified conditions
• Stability Data: Real-time and accelerated studies per ICH guidelines

Quality Control and Assurance

Our quality protocols ensure compliance at every stage:

• Raw Material Testing: Verified using pharmacopeial methods (USP/EP/IP)
• In-process Checks: Uniformity, weight variation, sterility, reconstitution time, particulate matter
• Final Product Testing: Assay (Potency), pH, Sterility, Endotoxin level, Water content, Particulate load
• Documentation: Certificate of Analysis (CoA), Sterility Certificates, BMR, and SOP compliance

Certifications & Regulatory Standards

BluepillExpress’s manufacturing infrastructure and processes meet the most stringent international norms:

• WHO-GMP Certified
• ISO 9001:2015 Certified
• FSSAI Licensed
• Compliant with ICH, USFDA, MHRA, and PIC/S guidelines for sterile injectables

Regulatory Documentation & Support

Our dedicated regulatory team ensures seamless product registration and documentation support for international clients:

• Certificate of Pharmaceutical Product (COPP)
• Product Dossier in CTD/ACTD Format
• Stability Data & Validation Reports
• GMP Certificate & Site Master File
• Certificate of Analysis (CoA) & MSDS
• Batch Manufacturing Records (BMR)
• Shipping Documents & Customs Declarations

Private Label Manufacturing & Customization

BluepillExpress supports white-label and private label manufacturing for pharmaceutical brands, distributors, and institutional suppliers. Our services include:

• Brand-name printing and logo integration
• Regulatory-compliant design support for box, vial, and insert
• Customizable strength options (e.g., 250 mg/250 mg, 500 mg/500 mg, 1 g/1 g)
• Batch-specific barcoding and QR traceability
• Support for hospital tenders and institutional procurement

Logistics & Export Capabilities

As a global pharmaceutical exporter, BluepillExpress offers:

• Export-ready documentation for over 30 international markets
• Cold chain logistics where required
• Air and sea freight arrangements with regulated freight forwarders
• Regulatory packaging and labeling support for MENA, Africa, Southeast Asia, and CIS regions
• Multilingual instructions and inserts as per MOH requirements

Target Clients

Our Imipenem & Cilastatin manufacturing is ideal for:

• Pharmaceutical Marketing Companies
• Critical Care and Antibiotic Drug Portfolios
• Institutional Buyers and Government Tenders
• Hospital Chains and ICU Medication Suppliers
• International Pharmaceutical Distributors
• NGOs and Public Health Procurement Projects

Why Choose BluepillExpress?

• Proven track record in sterile injectable manufacturing
• WHO-GMP and ISO-certified infrastructure
• Competitive pricing with uncompromised quality
• Complete regulatory support for product registration and exports
• Flexible minimum order quantities for global buyers
• Fast turnaround times and scalable production capacity
• Total confidentiality and IP protection for contract manufacturing

Conclusion

The combination of Imipenem & Cilastatin is a critical tool in the fight against resistant and hospital-acquired infections. At BluepillExpress, we are committed to manufacturing this life-saving formulation under the most stringent quality standards, with full regulatory and technical support to ensure successful distribution across local and global markets.

With our integrated capabilities, global partnerships, and trusted pharmaceutical expertise, BluepillExpress is your ideal third-party manufacturing partner for Imipenem & Cilastatin injectables—delivering excellence, safety, and reliability with every batch.