Meropenem

Meropenem is a broad-spectrum, beta-lactam antibiotic belonging to the carbapenem class. It is widely used in clinical settings for the treatment of serious and life-threatening infections caused by multidrug-resistant organisms. As one of the most potent antibiotics in modern medicine, Meropenem plays a critical role in combating bacterial resistance and treating severe hospital-acquired and community-acquired infections.

At BluepillExpress, we specialize in third-party and contract manufacturing of Meropenem for Injection, formulated and packaged in sterile, WHO-GMP-certified facilities. Our expertise in the production of injectable antibiotics, robust quality control systems, and global compliance capabilities allow us to deliver Meropenem products tailored to diverse market requirements and regulatory needs.

Product Overview

Product Name: Meropenem for Injection
Form: Sterile Lyophilized Powder
Route of Administration: Intravenous (IV)
Available Strengths:

• Meropenem 250 mg
• Meropenem 500 mg
• Meropenem 1 g
  Packaging: Single-dose vial in a monocarton, optionally with sterile water for injection

Therapeutic Category:

Carbapenem-Class Broad-Spectrum Antibiotic (Antibacterial – Injectable)

Mechanism of Action

Meropenem works by inhibiting bacterial cell wall synthesis, specifically by binding to penicillin-binding proteins (PBPs), which are essential for the bacterial cell wall structure. Its mechanism leads to cell lysis and bacterial death. Meropenem is effective against a wide range of gram-positive and gram-negative bacteria, including many anaerobic and aerobic pathogens.

It is known for its:

• Resistance to most beta-lactamases
• Broad spectrum of activity
• High stability in the presence of dehydropeptidase-1 (no need for co-administration with cilastatin)
• Effective penetration into tissues and body fluids

Indications

Meropenem for injection is indicated for the treatment of the following serious infections:

• Complicated intra-abdominal infections
• Bacterial meningitis
• Hospital-acquired and ventilator-associated pneumonia
• Sepsis and bacteremia
• Urinary tract infections (complicated and uncomplicated)
• Skin and soft tissue infections
• Febrile neutropenia
• Gynecological infections
• Pediatric infections (based on weight-specific dosing)

Why Choose BluepillExpress for Meropenem Manufacturing?

1. State-of-the-Art Injectable Manufacturing Facilities

Our dedicated sterile production lines for lyophilized injectables are equipped with advanced isolator systems, precision filling machines, and Class 100 aseptic processing environments. From formulation to vial filling and terminal sterilization, we ensure a contamination-free process that meets international standards.

2. Certifications and Quality Compliance

All Meropenem products manufactured by BluepillExpress are produced in WHO-GMP, ISO 9001:2015, and GLP-certified facilities. We adhere to international pharmacopeial standards including IP, USP, BP, and EP.

Available regulatory documentation:

• Certificate of Analysis (CoA)
• Batch Manufacturing Records (BMR)
• Certificate of Origin
• Stability Data
• Method of Analysis (MoA)
• Validation Reports (Analytical & Process)
• Free Sale Certificate
• CTD/ACTD Dossier (on request)

These documents ensure global acceptance of our Meropenem products in regulated and semi-regulated markets.

3. Global Export Capabilities

BluepillExpress has an established presence in over 35 countries across Asia, Africa, CIS, the Middle East, and Latin America. Our export team manages:

• Country-specific registration support
• WHO prequalification compliance (where applicable)
• Multi-lingual labeling and artwork
• Shipment coordination (air/sea freight with cold chain options)
• International logistics and documentation

We work with government tenders, institutional buyers, wholesalers, and private healthcare distributors.

4. Superior Product Stability and Packaging

Meropenem is highly sensitive to moisture and temperature, requiring strict control during manufacturing and storage. We ensure:

• Lyophilized (freeze-dried) presentation for increased stability
• Vials made from Type I or Type II borosilicate glass
• Tamper-evident aluminum seals and rubber stoppers
• Nitrogen flushing and vacuum sealing (if required)
• Options for pairing with sterile water for injection (as per market preference)

Shelf life typically ranges from 18 to 36 months, depending on formulation and storage conditions.

5. Quality Assurance and Quality Control

Our QA/QC framework is designed to ensure each batch meets the highest standards of identity, potency, purity, and sterility. Key tests include:

• Assay of Meropenem content (HPLC validated method)
• Bacterial endotoxin testing (BET)
• Sterility testing as per pharmacopeial standards
• Particulate matter and pH testing
• Water content (Karl Fischer method)
• Reconstitution time and appearance
• Container closure integrity
• Accelerated and long-term stability testing

All tests are conducted in qualified in-house laboratories or approved third-party testing labs.

Custom Formulation and Presentation

We offer flexible customization options to suit the specific requirements of our clients and their target markets:

• Branded or generic versions of Meropenem
• Multi-vial pack options (e.g., 10 vials per box for hospitals)
• Combo packs with disposables (syringes, saline, etc.)
• Vials with or without sterile water for injection
• Ready-to-register dossiers for marketing authorizations

Our product development team can also assist with variations in excipients and presentations based on local regulatory expectations.

Private Label and Contract Manufacturing Services

BluepillExpress provides full-service private labeling and contract manufacturing, helping pharmaceutical companies bring Meropenem to market under their own brand. Our services include:

• Custom label and packaging design
• Market-specific artwork and layout
• Brand development and regulatory compliance
• Batch coding and serialization (as required)
• Fast-track production for government tenders or emergency procurement

We support businesses of all sizes—from national distributors and hospital procurement companies to international NGOs and institutional buyers.

Target Markets and End Users

Our Meropenem for Injection is ideal for the following applications:

• Hospitals and tertiary care centers
• Government procurement agencies and tenders
• ICU and emergency departments
• Oncology and transplant units (for febrile neutropenia)
• Pediatric departments (dose-adjusted formats)
• International humanitarian aid programs

With increasing rates of antimicrobial resistance globally, the demand for high-quality Meropenem continues to grow. BluepillExpress ensures a reliable and consistent supply of this critical antibiotic to meet urgent public health needs.

Manufacturing Workflow

Our transparent and efficient third-party manufacturing process includes:

1. Requirement Analysis & Product Finalization
   • Strength, dosage form, packaging, labeling, regulatory scope
2. Quotation & Agreement
   • Pricing, terms, production schedule, and MOQ approval
3. Product Sample or Validation Batch
   • Optional sample development and documentation submission
4. Bulk Manufacturing & QC Testing
   • Sterile production with comprehensive in-process and post-process QA
5. Packaging & Branding
   • Labeling and secondary packaging as per client specifications
6. Logistics & Dispatch
   • Coordinated shipment with export documentation

Average production timeline: 30 to 40 working days, subject to order volume and labeling needs.

Advantages of Partnering with BluepillExpress

• WHO-GMP certified manufacturing for injectable antibiotics
• High-quality lyophilized powder with assured sterility
• Expertise in regulated market documentation
• End-to-end support from formulation to export
• Low minimum order quantities for market entry
• Proven track record in international government tenders

Conclusion

As the global burden of multidrug-resistant infections grows, the need for safe, reliable, and potent antibiotics such as Meropenem is more critical than ever. At BluepillExpress, we are committed to producing Meropenem formulations that meet global standards in sterility, efficacy, and regulatory compliance.

With cutting-edge facilities, expert personnel, and a client-centric approach, we offer a full range of third-party and contract manufacturing services to healthcare organizations, pharmaceutical brands, and institutional buyers worldwide.