Chloramphenicol

Chloramphenicol is a potent broad-spectrum antibiotic widely used to treat severe and life-threatening bacterial infections when other antibiotics are either ineffective or contraindicated. Known for its rapid bacteriostatic action, Chloramphenicol has a long-standing reputation in global medicine, especially for treating typhoid fever, bacterial meningitis, conjunctivitis, and infections caused by multidrug-resistant organisms.

As antibiotic resistance increases and demand grows for legacy, effective antibiotics, BluepillExpress offers global-standard third-party manufacturing of Chloramphenicol in oral, topical, and injectable forms. Our WHO-GMP and ISO-certified production facilities ensure quality, safety, and regulatory compliance for domestic and international clients alike.

What is Chloramphenicol?

Chloramphenicol is a broad-spectrum antibiotic originally derived from Streptomyces venezuelae and later synthesized chemically for large-scale production. It works by inhibiting bacterial protein synthesis at the 50S ribosomal subunit, halting the growth of various Gram-positive and Gram-negative pathogens.

Therapeutic Class: Broad-spectrum Antibacterial Agent
Mechanism of Action: Inhibits peptidyl transferase activity, interfering with protein synthesis
Available Forms: Capsules, Oral Suspension, Eye Drops, Eye Ointment, Injectable

Indications and Therapeutic Uses

Chloramphenicol is typically reserved for serious infections where other antibiotics have failed or cannot be used due to allergies or resistance. It is included in the WHO Model List of Essential Medicines, especially for low-resource and developing settings.

Primary Indications Include:

• Typhoid and paratyphoid fever (Salmonella infections)
• Meningitis (especially in penicillin-allergic patients)
• Rickettsial infections (when tetracyclines are contraindicated)
• Anaerobic bacterial infections
• Ocular infections: bacterial conjunctivitis, keratitis, and blepharitis
• Brain abscess and systemic sepsis (parenteral form)

While effective, Chloramphenicol must be used with caution due to rare but serious side effects, making quality control and formulation precision critical in its manufacture.

Why Choose BluepillExpress for Chloramphenicol Manufacturing?

At BluepillExpress, we understand the responsibility of manufacturing critical antibiotics like Chloramphenicol. Our facilities follow strict quality and sterility protocols, ensuring product safety and regulatory adherence at every level.

Key Advantages Include:

• WHO-GMP & ISO-certified manufacturing units
• Dedicated cleanrooms for ophthalmic and parenteral formulations
• Compliance with BP, USP, and IP standards
• Custom labeling, branding, and multilingual packaging
• Flexible order sizes and low MOQs
• Full support for international export documentation

We serve clients across regulated, semi-regulated, and developing markets, including governments, hospitals, and pharmaceutical distributors.

Product Forms & Strengths

We manufacture Chloramphenicol in multiple dosage forms to suit different clinical needs and regulatory markets.

Oral Formulations

• Chloramphenicol Capsules 250 mg / 500 mg
• Chloramphenicol Oral Suspension 125 mg/5 ml / 250 mg/5 ml

Topical Ophthalmic Formulations

• Chloramphenicol Eye Drops 0.5% w/v
• Chloramphenicol Eye Ointment 1% w/w

Parenteral Form (On Request)

• Chloramphenicol Sodium Succinate Injection 1 g/vial

Composition

All products are formulated with pharmaceutical-grade excipients and tested to meet pharmacopeial requirements.

Example: Chloramphenicol Capsule 500 mg

• Active Ingredient: Chloramphenicol base 500 mg
• Excipients: Magnesium stearate, starch, lactose monohydrate, and gelatin capsule shell

Example: Eye Drops 0.5%

• Active Ingredient: Chloramphenicol IP 0.5% w/v
• Excipients: Boric acid, sodium chloride, benzalkonium chloride (preservative), purified water

Preservative-free and single-use vials can be developed for sensitive formulations or special market needs.

Manufacturing Process

We follow stringent protocols and validated methods for all Chloramphenicol formulations to ensure safety, potency, and stability.

General Process Steps:

1. Raw Material Testing: All APIs and excipients undergo identity, purity, and microbial load checks
2. Blending & Granulation: Materials are mixed and processed for optimal uniformity
3. Capsule/Tablet Compression or Filling: Accurate dosing ensured via high-speed, validated equipment
4. Sterile Filtration (for ophthalmic/parenteral): Solutions filtered through 0.22-micron filters
5. Filling and Packaging: Conducted under ISO Class 5 or Class 7 cleanroom environments
6. Final QC Testing: Includes assay, sterility, endotoxin levels, particulate matter, and stability

All products are subject to batch traceability and controlled storage, ensuring regulatory readiness.

Quality Control and Compliance

At BluepillExpress, quality is the backbone of our operations. We implement multi-stage quality control procedures that align with international standards.

Each batch is tested for:

• Active pharmaceutical ingredient assay
• Dissolution and disintegration time
• Microbial contamination and endotoxin levels
• Uniformity of content and weight
• Sterility (for eye and injectable products)
• Heavy metal and residual solvent limits

We also conduct stability studies (accelerated and real-time) in accordance with ICH guidelines for Zones II, III, and IV, depending on the intended market.

Regulatory Documentation Support

Our team offers full regulatory documentation to facilitate registration and compliance with importing countries.

Standard Documents Provided:

• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Product Dossier (CTD format available)
• GMP, ISO, and Free Sale Certificates
• Stability and Validation Data
• Method of Analysis (MOA)
• Master Formula Records (MFR) and Batch Manufacturing Records (BMR)

Our dossier support team assists in filing for regulatory approvals across Africa, Asia-Pacific, CIS, Middle East, and Latin America.

Packaging and Branding

We offer complete customization of packaging and labeling as per client and country-specific needs.

Packaging Options Include:

• Capsules/Tablets: Alu-Alu / PVC-Alu blister packs (10×10, 10×1, 1×6 formats)
• Dry Syrup: HDPE bottle with measuring cap and flavoring for pediatric use
• Eye Drops/Ointment: LDPE dropper bottles, laminated tubes, and tamper-evident secondary packaging
• Injectables: Glass vials with flip-off caps, shrink wrap, and export-ready outer cartons

All packaging is compliant with FDA, EU, SFDA, TGA, and WHO labeling standards, where applicable.

Target Clients and Application Markets

We serve a diverse client base across multiple segments of the global pharmaceutical industry.

Our Chloramphenicol products are ideal for:

• Generic drug marketers and distributors
• Hospitals and clinical supply chains
• Government procurement agencies
• NGOs and humanitarian aid organizations
• Private label and white label antibiotic brands
• Tender-based international medical suppliers

Export Capabilities

BluepillExpress is a trusted pharmaceutical exporter serving over 30 countries globally. Our Chloramphenicol range is exported to:

• Africa: Kenya, Uganda, Nigeria, Ethiopia, Ghana
• Middle East: UAE, Iraq, Yemen, Jordan, Saudi Arabia
• Asia-Pacific: Philippines, Bangladesh, Vietnam, Cambodia
• CIS Countries: Uzbekistan, Kyrgyzstan, Georgia
• Latin America: Bolivia, Dominican Republic, Peru
• Island Nations: Papua New Guinea, Solomon Islands, Fiji

We manage all export logistics, including:

• Shipping documentation
• Regulatory and customs compliance
• Air and sea freight forwarding
• Cold chain management (for sensitive formulations)

Advantages of Partnering with BluepillExpress

Choosing BluepillExpress as your Chloramphenicol third-party manufacturing partner offers you:

• Access to WHO-GMP certified infrastructure
• Rapid product development and formulation support
• Low MOQ with scalability
• Cost-effective pricing with global competitiveness
• Dedicated regulatory and project management teams
• Confidential, white-label manufacturing support
• On-time production and delivery guarantees

We are committed to helping you grow your brand and serve healthcare markets effectively and ethically.