Cefalexin

Antibiotics continue to be the backbone of modern medicine, and the demand for well-tolerated, broad-spectrum options remains high across global healthcare systems. Among the most reliable and widely used antibiotics is Cefalexin (also spelled Cephalexin), a first-generation cephalosporin with proven efficacy in treating a wide range of bacterial infections. It is especially valued for its stability, broad coverage, oral availability, and safety profile.

As a trusted third-party pharmaceutical manufacturer, BluepillExpress specializes in the large-scale, regulatory-compliant manufacturing of Cefalexin formulations. We provide high-quality generic and branded-ready versions suitable for both domestic and international markets. Our solutions are tailored for private labeling, institutional supply, government tenders, and retail distribution, ensuring cost-efficiency, reliability, and global reach.

What is Cefalexin?

Cefalexin is a first-generation cephalosporin antibiotic with bactericidal activity, functioning by inhibiting bacterial cell wall synthesis. It is particularly effective against Gram-positive organisms and selected Gram-negative bacteria. Cefalexin is resistant to degradation by certain beta-lactamases and is used primarily for mild to moderate infections that are susceptible to oral antibiotic therapy.

Administered orally, it offers a convenient and highly effective treatment for upper respiratory tract infections, skin infections, urinary tract infections, and bone infections, among others.

Therapeutic Class

• Cephalosporin antibiotic (First-generation)
• Beta-lactam class of antimicrobials
• Bactericidal agent

Key Benefits of Cefalexin

1. Broad-Spectrum Activity

Cefalexin is active against many Gram-positive cocci including Staphylococcus aureus (non-MRSA), Streptococcus pyogenes, and select Gram-negative bacilli such as E. coli, Klebsiella pneumoniae, and Proteus mirabilis.

2. High Oral Bioavailability

It is rapidly absorbed when taken orally, achieving effective serum and tissue concentrations suitable for treating systemic infections.

3. Excellent Safety and Tolerability

Cefalexin is among the most well-tolerated oral antibiotics, with low incidence of severe side effects and a well-established safety profile in pediatric and elderly populations.

4. Flexible Dosage Forms

Manufactured as tablets, capsules, and dry syrups, Cefalexin can be tailored to a variety of patient needs—ideal for hospital, pharmacy, and home care settings.

5. Ideal for First-Line Use

Cefalexin is often used as a first-line treatment before culture sensitivity results, particularly in outpatient settings.

Indications

Cefalexin is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the following conditions:

• Respiratory tract infections (pharyngitis, tonsillitis, bronchitis)
• Skin and soft tissue infections (cellulitis, impetigo, abscesses)
• Bone and joint infections (osteomyelitis)
• Urinary tract infections (cystitis, urethritis)
• Ear infections (otitis media)
• Dental infections
• Prophylaxis in certain surgical procedures (where oral administration is preferred)

It is suitable for both adult and pediatric patients, with dosing regimens adjusted based on weight and severity of infection.

Available Strengths and Dosage Forms

BluepillExpress manufactures Cefalexin in multiple strengths and formats to meet diverse patient demographics and regulatory demands.

Oral Solid Dosage Forms

Capsules (Hard Gelatin or HPMC-based):

• Cefalexin 250 mg
• Cefalexin 500 mg

Tablets (Film-coated, uncoated on request):

• Cefalexin 250 mg
• Cefalexin 500 mg
• Cefalexin 750 mg (high-dose option)

Oral Liquid Dosage Forms (Dry Syrup)

• Cefalexin 125 mg / 5 ml
• Cefalexin 250 mg / 5 ml
• Available in 30 ml, 60 ml, and 100 ml bottles
• Supplied with sterile water for reconstitution and measuring spoon or cup
• Flavored for pediatric acceptance (e.g., orange, mango, raspberry)

Each formulation is developed to comply with USP/BP/EP standards and undergoes strict quality control throughout the production cycle.

Dosage and Administration

Dosage depends on the patient’s age, weight, severity of infection, and renal function. General guidelines include:

• Adults and adolescents: 250–500 mg every 6–12 hours; up to 4 gm/day for severe infections
• Pediatrics: 25–50 mg/kg/day in divided doses
• Treatment duration: Typically 7–14 days, depending on the site and type of infection

To be administered orally with or without food, under the direction of a licensed healthcare professional.

Manufacturing Capabilities

BluepillExpress provides third-party manufacturing of Cefalexin formulations with scalable production capacity, enabling quick response to bulk orders, government procurement, or new product launches.

Manufacturing Capabilities:

• Tablet and capsule production (up to 1 million units/day)
• Liquid oral dosage production (up to 100,000 bottles/day)
• Dry syrup filling and capping lines with in-house flavoring and granulation
• Fully automated blistering and strip packaging for tablets and capsules
• Label printing and customized branding services available

All production is handled in temperature- and humidity-controlled cleanrooms, with HEPA-filtered air systems and automated validation protocols.

Packaging Options

Primary Packaging:

• Capsules/Tablets: Blister packs (Alu-Alu, PVC), HDPE bottles
• Dry Syrups: Amber glass or plastic bottles with sealed cap, measuring spoon, and label

Secondary Packaging:

• Custom-designed mono cartons
• Multilingual labeling for export
• QR codes, serialization, barcoding for traceability
• Optional leaflet insert with dosage instructions and side effect warnings

We accommodate branded and generic formats, ensuring flexibility for private-label clients or retail distribution.

Certifications and Quality Assurance

BluepillExpress maintains internationally recognized certifications and adheres to stringent quality management systems across all stages of product development and production.

Certifications:

• WHO-GMP Certified
• ISO 22000:2018
• FSSAI-compliant
• FDA (India) manufacturing license
• EU and Gulf registration support available upon request

Quality Testing Includes:

• Active Ingredient Assay (Potency)
• Dissolution and Disintegration
• Microbial Contamination
• Heavy Metals
• Uniformity of Weight and Content
• Real-time and Accelerated Stability Studies

All batches are released only after internal QC and third-party lab validations, supported with a Certificate of Analysis (CoA).

Regulatory and Export Documentation

BluepillExpress provides complete documentation and export assistance to facilitate easy registration and compliance with importing country regulations.

Documents offered include:

• Certificate of Analysis (CoA)
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Certificate of Origin (COO)
• Product Dossier (CTD/ACTD/Module 1–5 upon request)
• Manufacturing License
• Stability Data (Zone II/IVB)
• MSDS and Label Artwork Files

We support dossier development for tender bidding, regulatory filings, and custom registration formats.

Shipping and Logistics

We offer end-to-end shipping solutions under EXW, FOB, CIF, or DDP terms based on your business model and destination country.

Services include:

• Export packing and labeling
• Freight forwarding coordination
• Custom clearance support
• Cold chain storage (if required)
• Sea and air shipping options
• Global reach across Africa, Latin America, Southeast Asia, Middle East, and CIS nations

Minimum Order Quantity and Lead Time

Formulation	Minimum Order Quantity	Lead Time
Capsules/Tablets	100,000 units	20–25 working days
Dry Syrup	25,000 bottles	20–30 working days
Sample Batch	10–20 packs	7–10 working days

Lead times may vary depending on packaging, documentation, and label approval.

Market Demand and Applications

Cefalexin remains a widely prescribed antibiotic due to its:

• High efficacy in common infections
• Affordable cost profile
• Ideal pharmacokinetics for outpatient use
• Low resistance rate compared to some second-generation antibiotics
• Global recognition in essential medicine lists (WHO, National Health Policies)

With increasing demand for oral broad-spectrum antibiotics, Cefalexin is a cornerstone product for:

• Pharmacy chains
• Generic medicine portfolios
• Government tender programs
• Institutional supply (hospitals and health centers)
• Pediatric and geriatric care products

Ideal Business Partners

We partner with:

• Domestic and international pharmaceutical marketing companies
• OTC drug marketers and retail brands
• Government procurement agencies and NGOs
• Exporters in regulated and semi-regulated markets
• Distributors seeking private-label solutions

Whether launching a new brand, expanding a generic portfolio, or responding to tender contracts, BluepillExpress ensures your Cefalexin products are market-ready and regulatory-compliant.

Why Choose BluepillExpress?

• End-to-end third-party manufacturing support
• WHO-GMP certified infrastructure
• Competitive pricing for large-volume manufacturing
• Full regulatory assistance
• Customization in formulation, branding, and packaging
• Trusted by clients across 30+ countries
• Transparent communication and quality-first philosophy

Conclusion

Cefalexin is a tried-and-tested antibiotic with global acceptance and clinical trust. With BluepillExpress as your manufacturing partner, you gain access to a high-quality, scalable, and regulatory-compliant solution tailored to meet the rising demands of healthcare markets around the world.

From concept to commercialization, we deliver more than medicine—we deliver partnership, precision, and performance.