Tetracyclin HCL

In the ever-evolving world of infectious diseases, antibiotics continue to play a vital role in the treatment and prevention of a wide variety of bacterial infections. Among the earliest and most widely used broad-spectrum antibiotics is Tetracycline Hydrochloride (HCL). Due to its time-tested efficacy, low cost, and broad antimicrobial spectrum, Tetracycline HCL remains in demand across global healthcare systems, particularly in regions with rising antimicrobial resistance or limited access to newer agents.

BluepillExpress, a WHO-GMP certified third-party pharmaceutical manufacturer, offers end-to-end contract manufacturing services for Tetracycline HCL in oral tablet and capsule forms. With extensive manufacturing capabilities, robust regulatory support, and custom formulation expertise, BluepillExpress provides high-quality, affordable antibiotic solutions tailored to your market requirements.

What is Tetracycline HCL?

Tetracycline HCL is a semi-synthetic derivative of the naturally occurring tetracycline group of antibiotics. It belongs to the bacteriostatic class of antibiotics and works by inhibiting bacterial protein synthesis. Specifically, Tetracycline binds to the 30S ribosomal subunit, preventing the attachment of aminoacyl-tRNA to the mRNA-ribosome complex, thereby halting bacterial replication.

With broad-spectrum activity against both Gram-positive and Gram-negative bacteria, as well as atypical organisms, Tetracycline is highly effective for respiratory tract infections, skin infections, urinary tract infections, sexually transmitted infections, and zoonotic diseases.

Therapeutic Class

• Broad-Spectrum Antibiotic
• Tetracycline Derivative
• Bacteriostatic Agent

Key Benefits of Tetracycline HCL

1. Broad Antibacterial Coverage

Effective against a wide range of pathogens, including Streptococcus spp., Staphylococcus aureus, Haemophilus influenzae, Chlamydia trachomatis, Mycoplasma pneumoniae, Rickettsiae, Brucella, and Vibrio cholerae.

2. Cost-Effective and Globally Accepted

Affordable and well-documented, making it ideal for developing countries, institutional programs, NGOs, and public health sectors.

3. Multiple Indications

Used for systemic bacterial infections, topical acne, rickettsial infections, and travel-related diseases such as cholera and malaria (as an adjunct).

4. WHO Essential Medicine

Included in the WHO Model List of Essential Medicines, ensuring its importance and relevance for global procurement and supply.

5. Customizable Strengths and Formulations

Available in tablets, capsules, and custom doses suitable for tender supply and regulatory requirements.

Indications

Tetracycline HCL is indicated for the treatment of:

• Respiratory tract infections (e.g., bronchitis, pneumonia)
• Sexually transmitted infections (chlamydia, syphilis, gonorrhea)
• Skin infections (acne vulgaris, folliculitis, infected wounds)
• Urinary tract infections
• Gastrointestinal infections (cholera, traveler’s diarrhea)
• Rickettsial diseases (Rocky Mountain spotted fever, typhus)
• Brucellosis, plague, and Lyme disease
• Prophylaxis of malaria (in combination therapy)

It is also useful for treating infections in penicillin-allergic individuals and is sometimes used in periodontal therapy.

Available Dosage Forms and Strengths

BluepillExpress manufactures Tetracycline HCL in the following standard dosage forms and strengths:

Tablets

• Tetracycline HCL 250 mg
• Tetracycline HCL 500 mg

Capsules

• Tetracycline HCL 250 mg
• Tetracycline HCL 500 mg

Each formulation is produced using USP/BP/IP-compliant APIs, with validated processes ensuring uniform potency and bioavailability.

Custom formulations and strengths (e.g., dispersible tablets or combination therapies) are available based on client specifications.

Dosage and Administration

Adults:

• 250–500 mg every 6 hours orally, depending on infection type and severity

Children over 8 years (weight-based dosing):

• 25–50 mg/kg/day divided into 4 doses

Duration of Therapy:

• Typically 7–14 days, based on infection type and clinical response

Important Notes:

• Take on an empty stomach with water, 1 hour before or 2 hours after meals
• Avoid concurrent intake of dairy products, iron, or antacids which reduce absorption
• Not recommended for children under 8 years or pregnant women due to risk of permanent teeth discoloration and enamel hypoplasia

Mechanism of Action

Tetracycline HCL works by:

• Binding to the 30S subunit of bacterial ribosomes
• Preventing aminoacyl-tRNA attachment
• Halting protein synthesis
• Resulting in bacteriostatic activity, preventing further bacterial growth

Its activity is concentration-independent but requires continuous plasma levels to maintain efficacy.

Pharmacokinetics

• Absorption: Rapid oral absorption (60–80%)
• Bioavailability: Reduced by food, calcium, and magnesium
• Peak Plasma Concentration: 2–4 hours post-administration
• Distribution: Widely distributed, crosses placenta
• Excretion: Primarily renal; partially fecal in patients with impaired renal function
• Half-life: 6–11 hours

Manufacturing Capabilities

BluepillExpress offers large-scale, GMP-certified manufacturing capabilities suited for high-volume antibiotic production.

Facilities Include:

• Dedicated lines for antibacterial APIs and formulations
• Granulation, compression, encapsulation, and coating lines
• Dust-free environments for safe handling of tetracycline group antibiotics
• In-house analytical labs for stability, dissolution, assay, and microbial testing
• Automation for blister packing, bottle filling, and strip sealing

Our quality-driven process supports white-label manufacturing, bulk supply, and institutional contract production.

Packaging and Labeling

We provide flexible and compliant packaging solutions tailored to domestic, hospital, export, and OTC requirements.

Tablet & Capsule Packaging Options:

• Blister packs (PVC/Alu, Alu-Alu)
• HDPE bottles with or without desiccants
• 10×10, 10x1x10 strip packs
• Bulk jars for hospital supply

Labeling Services:

• Multilingual carton and label design
• Custom artwork and brand integration
• Barcode, QR code, and serialization (as per client or regulatory needs)
• Patient information leaflets (PIL) included upon request

Quality Assurance and Compliance

At BluepillExpress, every product batch undergoes rigorous testing and documentation to ensure global compliance and therapeutic integrity.

Certifications:

• WHO-GMP
• ISO 22000:2018
• FSSAI (if oral suspensions are requested)
• Indian FDA license
• Regulatory dossier support for CTD and ACTD markets

Quality Tests Conducted:

• Assay and uniformity
• Dissolution and disintegration
• Microbial limit tests
• Impurity profiling and stability testing
• Moisture content (LOD) and hardness/friability (for tablets)

A complete Certificate of Analysis (CoA) and Batch Manufacturing Record (BMR) is provided with every batch.

Regulatory Documentation Support

BluepillExpress provides complete documentation for regulatory and registration purposes:

Available Documents:

• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Certificate of Origin (COO)
• CTD/ACTD Dossiers (Modules 1–5)
• MSDS (Material Safety Data Sheet)
• Stability data for real-time and accelerated conditions
• Product development and validation reports

We assist in registrations across Africa, Asia, CIS, Latin America, and Middle Eastern markets.

Export and Logistics

We support full-service global exports with:

• Incoterms: EXW, FOB, CIF, DDP
• Air, sea, and land shipping coordination
• Tamper-proof bulk packaging and pallets
• Product documentation for customs clearance
• Express delivery for sample lots

Our team ensures safe and on-time delivery to clients in over 30 countries.

Minimum Order Quantities and Lead Times

Product Form	MOQ	Lead Time
Tablets / Capsules	100,000 units	20–25 working days
Custom Packaging	50,000 units	25–30 working days
Sample Lots	20–50 packs	7–10 working days

Market Demand and Applications

Tetracycline HCL remains in demand due to:

• Inclusion in WHO Essential Medicines List
• Use in NGO and government tenders
• Broad applications across infectious disease, gynecology, dermatology, and dental medicine
• Availability in OTC and prescription models in various markets
• Use in combination therapies for malaria and H. pylori (in triple therapy regimens)

Ideal Business Partners

We collaborate with:

• Generic medicine exporters
• Public health distributors
• Government tender participants
• OTC product marketers
• NGOs and institutional suppliers
• Private-label pharmaceutical companies

BluepillExpress supports custom brand development as well as bulk generic supply under your name or label.

Why Choose BluepillExpress?

• WHO-GMP certified and globally trusted
• Decades of expertise in antibiotic manufacturing
• Competitive pricing for high-volume production
• Customizable packaging, dosage forms, and branding
• Full regulatory and technical support
• Reliable delivery and transparent communication

Conclusion

Tetracycline HCL continues to serve as a trusted, affordable, and clinically versatile antibiotic, especially in areas where broad-spectrum oral therapy is essential. From respiratory infections to STIs, Tetracycline offers proven efficacy at a low cost, making it a staple in global pharmaceutical supply chains.

BluepillExpress delivers the quality, consistency, and compliance you need to succeed in antibiotic manufacturing. Whether for export, tender supply, or private-label development, we ensure your Tetracycline HCL products meet the highest standards—every time.