Antibiotic APIs
Life-Saving Active Pharmaceutical Ingredients for Bacterial Infection Treatment
About Antibiotic APIs
Holiness Pharmaceutical is a leading manufacturer and global exporter of high-quality Antibiotic APIs used in treating bacterial infections. Our comprehensive portfolio includes macrolides, fluoroquinolones, beta-lactams, and other antibacterial classes manufactured under strict WHO-GMP guidelines. We are committed to combating antimicrobial resistance through quality manufacturing and supporting global efforts to ensure access to effective antibiotics.
Key Features
- WHO-GMP certified antibiotic manufacturing facility
- Compliance with IP, BP, USP, and EP pharmacopeial standards
- Multiple antibiotic classes and generations
- Advanced fermentation and synthesis technology
- Comprehensive microbial contamination control
- Sterility assurance for parenteral products
- Complete regulatory documentation and DMF support
- Support for antimicrobial stewardship programs
Application Areas
Respiratory Infections
Treatment of pneumonia, bronchitis, and upper respiratory tract infections
Urinary Tract Infections
Management of UTIs, cystitis, and pyelonephritis
Skin and Soft Tissue Infections
Treatment of cellulitis, wound infections, and abscesses
Gastrointestinal Infections
Management of bacterial gastroenteritis and enteric infections
Systemic Infections
Treatment of sepsis, bacteremia, and severe systemic infections
Quality Assurance
Our antibiotic APIs undergo rigorous microbiological and chemical testing including potency assays, sterility testing for parenteral products, bacterial endotoxin testing, HPLC analysis for purity and related substances, residual solvent analysis, heavy metal testing, and comprehensive stability studies. Each batch is certified to meet international standards for antimicrobial efficacy and safety.
Our Antibiotic APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Amoxicillin Trihydrate API | 61336-70-7 | IP/ BP/ USP | API Powder | View Product |
Azithromycin API | 83905-01-5 | IP/BP/USP | API Powder | View Product |
Ciprofloxacin HCL API | 93107-08-5 | IP/BP/USP | API Powder | View Product |
Ciprofloxacin Hydrochloride Monohydrate API | 86393-32-0 | IP/BP/USP | API Powder | View Product |
Clarithromycin API | 81103-11-9 | IP/USP | API Powder | View Product |
Delafloxacin Meglumine API | 352458-37-3 | IP/BP/USP | API Powder | View Product |
Erythromycin API | 114-07-8 | IP/BP/USP | API Powder | View Product |
Levofloxacin Hemihydrate API | 138199-71-0 | IP/BP/USP | API Powder | View Product |
Linezolid API | 165800-03-3 | USP | API Powder | View Product |
Mupirocin Calcium API | 115074-43-6 | IP/BP/USP | API Powder | View Product |
Frequently Asked Questions
What are Antibiotic APIs?
Antibiotic APIs are active pharmaceutical ingredients that kill or inhibit bacterial growth, used to treat bacterial infections. They include various classes: macrolides (azithromycin), fluoroquinolones (ciprofloxacin), beta-lactams (amoxicillin), and others, each with specific mechanisms of action and spectrum of activity against different bacteria.
Which antibiotic APIs does Holiness Pharmaceutical manufacture?
We manufacture Azithromycin (macrolide), Ciprofloxacin and Levofloxacin (fluoroquinolones), Amoxicillin Trihydrate (beta-lactam), Clarithromycin (macrolide), Erythromycin (macrolide), Mupirocin Calcium (topical antibiotic), and related antibacterial APIs meeting international pharmacopeial standards.
How do you prevent cross-contamination in antibiotic manufacturing?
We maintain dedicated production areas for different antibiotic classes, implement strict cleaning validation protocols, use closed processing systems, maintain positive pressure differentials, conduct environmental monitoring, and follow comprehensive change-over procedures. Beta-lactam antibiotics are manufactured in completely segregated facilities to prevent cross-contamination and allergic reactions.
What is the difference between bactericidal and bacteriostatic antibiotics?
Bactericidal antibiotics like fluoroquinolones and beta-lactams kill bacteria directly, while bacteriostatic antibiotics like macrolides inhibit bacterial growth and reproduction, allowing the immune system to eliminate the infection. The choice depends on infection severity, patient immune status, and bacterial susceptibility. We manufacture both types.
How do you ensure potency and stability of antibiotic APIs?
We conduct microbiological potency assays using validated bioassay methods, chemical potency determination via HPLC, and comprehensive stability studies under various conditions. Antibiotics are packaged in moisture-barrier containers with proper labeling of storage conditions. Stability data supporting shelf life is provided with regulatory documentation.
Do you manufacture APIs for combination antibiotic products?
Yes, we supply APIs for combination products. We provide compatibility data, stability studies in combination, and technical support for formulation development. Our regulatory documentation supports combination product registrations globally.
How do you address antibiotic resistance concerns?
We support antimicrobial stewardship by ensuring consistent high-quality APIs that maintain therapeutic efficacy, providing proper dosing guidance to prevent sub-therapeutic levels, supporting development of newer generation antibiotics, and participating in quality surveillance programs. We also ensure proper environmental controls to prevent antibiotic residues in manufacturing effluents.
What special handling is required for beta-lactam antibiotics?
Beta-lactam antibiotics require dedicated manufacturing facilities due to high potency and allergenicity risks. We maintain completely segregated production areas, implement strict personnel training, use specialized containment systems, and follow rigorous cleaning validation. These measures prevent cross-contamination and protect operators and patients from allergic reactions.