Metronidazole

Metronidazole is a widely prescribed antibiotic and antiprotozoal agent used to treat various anaerobic bacterial and protozoal infections. It is highly effective against organisms causing conditions such as bacterial vaginosis, amoebiasis, giardiasis, trichomoniasis, and certain intra-abdominal or dental infections. Available in oral, topical, and intravenous forms, Metronidazole is essential in antimicrobial regimens, especially in the treatment of anaerobic infections and infections associated with surgical or gynecological procedures.

At BluepillExpress, we offer high-quality, WHO-GMP certified third-party manufacturing of Metronidazole in multiple dosage forms, including tablets, capsules, suspensions, IV infusions, and topical gels. We cater to domestic and international pharmaceutical companies, institutional buyers, and public health tenders, with complete regulatory support, brand customization, and consistent batch delivery.

What is Metronidazole?

Metronidazole is a synthetic nitroimidazole derivative with potent activity against anaerobic bacteria and protozoa. It is selectively taken up by anaerobic organisms and reduced to its active form, which disrupts DNA synthesis, leading to cell death. Due to its broad spectrum and excellent tissue penetration, Metronidazole is used across diverse therapeutic settings.

Therapeutic Class: Nitroimidazole Antibiotic and Antiprotozoal
Mechanism of Action: Inhibits nucleic acid synthesis in anaerobes by DNA strand breakage
Routes of Administration: Oral, Intravenous, Topical, Vaginal

Therapeutic Indications

Metronidazole is used for the treatment and prophylaxis of various bacterial and protozoal infections. It is effective alone or in combination with other antimicrobials.

Key Indications:

• Amoebiasis (intestinal and hepatic)
• Giardiasis
• Trichomoniasis (urogenital)
• Bacterial vaginosis
• Pelvic inflammatory disease (PID)
• Intra-abdominal infections (peritonitis, abscesses)
• Dental infections (acute necrotizing gingivitis, abscesses)
• H. pylori eradication (in combination therapy)
• Surgical prophylaxis (especially colorectal or gynecological procedures)
• Anaerobic septicemia and brain abscesses
• Skin and soft tissue infections caused by anaerobes

Metronidazole is included in the World Health Organization’s List of Essential Medicines, underlining its global therapeutic importance.

Why Choose BluepillExpress?

BluepillExpress brings decades of expertise in third-party manufacturing of anti-infectives, with specialized capabilities for handling antibiotics, antiprotozoals, and intravenous formulations. Our quality systems and export experience ensure that clients receive products that meet regulatory requirements and global market demands.

Key Manufacturing Advantages:

• WHO-GMP certified production units
• ISO 9001:2015 quality assurance standards
• Dedicated antibiotic and nitroimidazole manufacturing lines
• In-house R&D for formulation development and stability testing
• Regulatory documentation compliant with IP, BP, USP, and EP
• Support for private label, OEM, and white-label contracts
• Scalable manufacturing capacity with flexible minimum order quantities
• Active export to over 40 countries across Africa, Asia, LATAM, and CIS regions

Available Dosage Forms and Strengths

At BluepillExpress, we offer Metronidazole in multiple strengths and delivery formats to address clinical needs and patient preferences.

Oral Formulations:

• Metronidazole Tablets 200 mg / 400 mg / 500 mg
• Metronidazole Capsules 250 mg / 500 mg
• Metronidazole Oral Suspension 200 mg/5 mL or 250 mg/5 mL

Parenteral Formulations:

• Metronidazole Injection 500 mg/100 mL IV Infusion (Ready-to-use or concentrate)

Topical and Vaginal Forms:

• Metronidazole Gel 0.75% / 1% (for dermatological or vaginal use)
• Metronidazole Vaginal Gel (0.75% w/w)
• Metronidazole Cream (1% topical antibacterial)

We also offer combination therapies such as Metronidazole + Norfloxacin or Metronidazole + Diloxanide, based on client and market needs.

Product Composition

We manufacture all Metronidazole formulations using pharmacopeia-grade APIs and high-quality excipients, optimized for bioavailability and patient safety.

Example Composition – Metronidazole 500 mg Tablet:

• Active Ingredient: Metronidazole BP/USP/IP 500 mg
• Excipients: Microcrystalline cellulose, starch, magnesium stearate, sodium starch glycolate, colloidal silicon dioxide
• Coating (Optional): Film-coated tablets for ease of swallowing and bitter taste masking

Custom formulations with lactose-free, gluten-free, or sugar-free options are available upon request.

Manufacturing Process

We follow validated, SOP-driven production processes under GMP conditions for all forms of Metronidazole. Our facilities maintain separate areas for antibiotics to avoid cross-contamination.

Standard Manufacturing Workflow (Tablets):

1. API Verification and Dispensing
2. Granulation (wet or dry based on formula)
3. Blending with lubricants and binders
4. Tablet compression and optional coating
5. Visual inspection, coding, and packing
6. In-process QC checks and batch release

IV Infusion Workflow:

• Prepared in sterile areas (Class 100 cleanroom)
• Utilizes automated filling machines and laminar airflow systems
• Terminal sterilization via autoclave or filtration
• Packed in glass vials or plastic infusion bottles (FFS technology available)

Quality Control and Compliance

BluepillExpress is committed to quality excellence. Every batch undergoes thorough quality control and microbiological testing.

QC Parameters:

• Assay and content uniformity
• Dissolution profile (oral forms)
• pH and osmolality (injectables)
• Sterility and endotoxin testing (for IV)
• Microbial limit testing (topical and oral suspensions)
• Impurity profiling (HPLC/UV)
• Stability testing (ICH guidelines)

Every batch is accompanied by a Certificate of Analysis (COA) and full quality dossier as per international regulatory standards.

Packaging and Private Labeling

We offer custom packaging options that meet export market requirements, patient preferences, and branding objectives.

Packaging Formats:

• Blister Packs (Alu-Alu, PVC-Alu) – 10×10, 1×10 formats
• HDPE Bottles – For oral suspensions and tablets
• IV Infusion Bottles – 100 mL plastic/glass with tamper-evident caps
• Tube Packaging – For topical gel or cream
• Multilingual carton and insert printing
• Serialization, QR codes, and barcoding available

We support OEM/private label development, from artwork design to customized foil printing and carton layout.

Regulatory Support and Documentation

We provide comprehensive documentation to support registrations, export approvals, and tenders in global markets.

Available Documents:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Certificate of Analysis (COA)
• CTD/ACTD-format Product Dossier
• Stability Data (real-time and accelerated)
• Batch Manufacturing Record (BMR)
• Master Formula Record (MFR)
• Method of Analysis (MOA)
• Safety Data Sheet (SDS)
• Product Label and Patient Leaflet

Export and Supply Chain Capabilities

BluepillExpress is trusted by partners across Africa, Asia, Latin America, the CIS region, and the Middle East, with proven expertise in international shipping, customs documentation, and multilingual labeling.

Key Export Destinations:

• Africa: Nigeria, Ghana, Kenya, Ethiopia, Tanzania
• Asia: Philippines, Vietnam, Bangladesh, Sri Lanka, Nepal
• Middle East: Iraq, Yemen, UAE, Jordan
• CIS Countries: Uzbekistan, Kazakhstan, Armenia
• LATAM & Caribbean: Bolivia, Dominican Republic, Peru
• Island Nations: Maldives, Papua New Guinea

We offer support for air freight, sea freight, and local logistics coordination with all necessary documentation for clearance.

Ideal Clients for Metronidazole Manufacturing

• Generic pharmaceutical marketing companies
• Government and institutional healthcare suppliers
• NGOs and humanitarian organizations
• Hospital and clinic procurement agencies
• Tender participants for public health programs
• OTC and private label brand owners
• Exporters in regulated and semi-regulated markets

Why Partner with BluepillExpress?

• WHO-GMP certified and export-ready Metronidazole manufacturing
• Multiformat capabilities (oral, injectable, topical)
• Flexible production volumes and scalable supply
• Custom formulation and packaging development
• End-to-end regulatory and documentation assistance
• Reliable global logistics and shipment tracking
• Competitive pricing with uncompromised quality