IndiaMart
FIEO
In the ever-evolving world of infectious disease management, Clindamycin Hydrochloride continues to be a critical therapeutic tool for clinicians worldwide. As an effective lincosamide antibiotic, Clindamycin plays a significant role in the treatment of bacterial infections, especially those caused by anaerobic organisms and Gram-positive cocci. It is widely used in both community and hospital settings for skin, dental, respiratory, and gynecological infections.
At BluepillExpress, we specialize in the third-party manufacturing of high-quality Clindamycin Hydrochloride formulations in multiple dosage forms. With decades of pharmaceutical experience, WHO-GMP certified facilities, and extensive export expertise, we ensure that your product is manufactured with precision, supported by documentation, and ready for global distribution.
Product Overview
Generic Name: Clindamycin Hydrochloride
Pharmacological Class: Lincosamide Antibiotic
Available Dosage Forms:
Clindamycin Capsules
Clindamycin Tablets (Hydrochloride equivalent)
Clindamycin Oral Solution / Syrup
Clindamycin Injection (IV/IM)
Clindamycin Topical Gel / Lotion / Solution
Strengths Available:
Capsules: 75 mg, 150 mg, 300 mg
Oral Solution: 75 mg/5 ml
Injection: 150 mg/ml in 2 ml and 4 ml ampoules or vials
Topical Solution/Gel: 1% w/v
Pharmacopoeial Compliance: IP / USP / BP (as per client requirements)
Manufacturing Type: Third-party or contract manufacturing under private label
Packaging Options:
Blister, alu-alu, bottle packs (oral and topical), ampoules, FFS vials, mono-cartons with printed leaflets
Pharmacology and Mechanism of Action
Clindamycin Hydrochloride is a semi-synthetic derivative of lincomycin. It works by binding to the 50S subunit of the bacterial ribosome, thereby inhibiting bacterial protein synthesis. This results in a bacteriostatic effect and, at higher concentrations, bactericidal activity against susceptible pathogens.
Clindamycin has a high affinity for anaerobic bacteria and Gram-positive aerobic organisms, including Staphylococcus aureus, Streptococcus pyogenes, and other streptococcal species. It also has significant tissue penetration, including bone, which makes it useful in osteomyelitis and dental infections.
Antimicrobial Spectrum
Clindamycin is active against:
Anaerobic bacteria (e.g., Bacteroides fragilis)
Gram-positive cocci (e.g., Staphylococcus aureus, including some MRSA strains)
Streptococcus pneumoniae
Propionibacterium acnes (topical application)
Toxoplasma gondii (in combination therapy)
Plasmodium spp. (as adjunctive antimalarial in certain regimens)
It is not effective against most Gram-negative aerobic bacteria and should be used based on susceptibility patterns.
Indications
Clindamycin is indicated in the treatment of a wide range of infections, including:
Skin and soft tissue infections (boils, abscesses, cellulitis)
Dental infections and periodontal abscesses
Bone and joint infections (osteomyelitis)
Lower respiratory tract infections (bronchitis, pneumonia)
Pelvic inflammatory disease (PID), endometritis
Intra-abdominal infections (in combination with other antibiotics)
Septicemia and bacterial endocarditis (in selected cases)
Toxoplasmosis (in immunocompromised patients)
Acne vulgaris (topical gel/lotion)
Clindamycin is also used as an alternative in patients with penicillin allergies.
Dosage and Administration
Oral Dosage for Adults:
150 mg to 300 mg every 6 to 8 hours, depending on the severity of the infection
Pediatric Oral Dosage:
8–20 mg/kg/day divided into 3–4 equal doses
Parenteral Dosage:
600–2700 mg/day IV or IM in 2–4 divided doses, depending on the infection severity
Topical Use:
Apply thin layer once or twice daily to affected skin areas
Duration of Therapy:
Usually 7 to 14 days; longer in chronic or bone infections
Note: Dose adjustment is necessary in hepatic impairment and in prolonged therapy due to the risk of C. difficile-associated diarrhea.
Benefits of Clindamycin Hydrochloride
Excellent activity against anaerobic bacteria and Gram-positive aerobes
High bioavailability in oral and parenteral forms
Deep tissue penetration, including into bones
Multiple dosage forms for flexible treatment options
Preferred antibiotic in dental, orthopedic, and gynecological practice
Effective adjunctive treatment in acne and toxoplasmosis
Alternative in patients with penicillin allergy
Why Choose BluepillExpress for Clindamycin Manufacturing?
WHO-GMP and ISO Certified Production Units
BluepillExpress operates world-class pharmaceutical manufacturing facilities with GMP-compliant infrastructure, sterile production lines for injectables, and high-speed filling lines for capsules and oral solutions.
Customizable Formulations
We provide flexibility in formulation, flavor (for pediatric syrup), preservatives (paraben-free), and packaging. Options include alcohol-free oral solutions, sugar-free syrups, and unit-dose oral sachets.
Extensive Regulatory Support
We offer the complete regulatory and documentation package, including:
Certificate of Analysis (COA)
Certificate of Pharmaceutical Product (COPP)
Free Sale Certificate
Stability Data (real-time and accelerated)
Master Formula Record (MFR)
Product Technical Dossiers (CTD/ACTD format available)
MOH registration assistance in multiple countries
Global Export Expertise
Clindamycin products from BluepillExpress are exported to:
Africa (Nigeria, Kenya, Ghana, Tanzania)
Asia (India, Philippines, Vietnam, Myanmar)
Latin America (Bolivia, Guatemala, Peru)
Middle East (Yemen, Iraq, Jordan, UAE)
CIS & Central Asia (Uzbekistan, Kazakhstan, Kyrgyzstan)
Europe (select semi-regulated markets)
We ensure full compliance with packaging, labeling, and transport regulations for each destination.
Stringent Quality Control
Our products undergo comprehensive in-process and post-production testing, including:
API assay and related substances
Content uniformity and dissolution
Microbial limit testing
Sterility testing (for injections)
Preservative content analysis (for topical and oral solutions)
Container-closure integrity testing
Packaging and Labeling Services
We offer a wide range of packaging services to suit retail, institutional, and export channels:
Alu-Alu and PVC blister packing for capsules and tablets
PET or HDPE bottles with child-resistant caps for syrups
Topical bottles with droppers or nozzles for dermatological use
Sterile ampoules and vials for injection
Multilingual labels (English, French, Spanish, Arabic, Russian)
Private label and OEM branding services
Tamper-evident, serialized labeling on request
QR-coded track-and-trace authentication (for regulated markets)
Manufacturing Process and Partner Support
BluepillExpress ensures a smooth, transparent, and professional third-party manufacturing experience.
Step 1: Requirement Discussion and NDA
Product type, dosage form, and regulatory scope are discussed, and a confidentiality agreement is signed.
Step 2: Customization and Quotation
Product specifications and packaging are finalized. A competitive quote and lead time are shared.
Step 3: Sampling and Approval
Trial batch or samples are developed and provided for approval before commercial production.
Step 4: Production and Quality Assurance
Commercial batches are manufactured under strict GMP guidelines. Full quality testing and validation are performed.
Step 5: Packaging, Dispatch, and Documentation
Products are packed as per your branding and dispatched with supporting documents for domestic or export use.
Market Potential and Commercial Relevance
With a significant rise in community-acquired infections, post-surgical infections, and skin-related conditions, Clindamycin continues to enjoy strong demand across both public and private healthcare systems. Its relevance in dental practice, dermatology, and gynecology further enhances its market value.
Clindamycin also enjoys a prominent position in national essential medicines lists and treatment guidelines, making it a critical product for tenders, institutional procurement, and public health programs.
By partnering with BluepillExpress, pharmaceutical companies can introduce a proven product to the market under their brand with confidence in quality, stability, and regulatory compliance.
Ideal For
Pharmaceutical marketers launching antibiotic or dental care lines
Distributors and wholesalers in domestic and export markets
Healthcare organizations and hospitals requiring institutional packs
NGOs and government contractors supplying national health programs
Private-label brands needing ready-to-register dossiers and quick turnaround
Conclusion
Clindamycin Hydrochloride remains an indispensable antibiotic in the global pharmaceutical landscape, offering reliable treatment against a range of infections, particularly those involving anaerobes and resistant Gram-positive organisms. With a variety of oral, parenteral, and topical formulations available, the molecule presents significant commercial opportunity and clinical relevance.
BluepillExpress brings unmatched expertise in third-party manufacturing of Clindamycin products. We combine advanced infrastructure, robust quality systems, international documentation capabilities, and market insights to help you scale your brand in competitive markets.
