Anti-Bacterial APIs
Premium Antibacterial Active Pharmaceutical Ingredients for Infection Control
About Anti-Bacterial APIs
Holiness Pharmaceutical manufactures and exports high-quality Anti-Bacterial APIs for treating various bacterial infections in humans and animals. Our portfolio includes fluoroquinolones, nitrofurans, and glycylcyclines manufactured under WHO-GMP standards. We serve pharmaceutical and veterinary companies globally, providing APIs for developing broad-spectrum antibacterial medications that combat resistant bacteria.
Key Features
- WHO-GMP certified antibacterial manufacturing facility
- Compliance with IP, EP, USP, and veterinary pharmacopeial standards
- Broad-spectrum antibacterial agents
- Advanced synthesis technology for complex molecules
- Both human and veterinary pharmaceutical grades
- Comprehensive microbial contamination control
- Complete regulatory documentation and DMF support
- Technical support for multiple dosage forms
Application Areas
Urinary Tract Infections
Treatment of complicated and uncomplicated UTIs, cystitis, and pyelonephritis
Respiratory Infections
Management of pneumonia, bronchitis, and respiratory bacterial infections
Skin and Soft Tissue Infections
Treatment of complicated skin infections and diabetic foot infections
Multidrug-Resistant Bacteria
Treatment options for resistant Gram-positive and Gram-negative bacteria
Veterinary Applications
Antibacterial treatment in livestock, poultry, and companion animals
Quality Assurance
Our anti-bacterial APIs undergo rigorous quality testing including potency assays by microbiological and chemical methods, HPLC analysis for purity and related substances, chiral purity assessment for fluoroquinolones, residual solvent analysis, heavy metal testing, and comprehensive microbiological evaluation including sterility testing for parenteral products. Each batch meets stringent antimicrobial efficacy standards.
Our Anti-Bacterial APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Enrofloxacin API | 93106-60-6 | - | API Powder | View Product |
Nifuroxazide API | 965-52-6 | BP/EP/USP | API Powder | View Product |
Nitrofurantoin Anhydrous API | 67-20-9 | IP/USP | API Powder | View Product |
Nitrofurantoin Monohydrate API | 17140-81-7 | IP/USP | API Powder | View Product |
Ofloxacin API | 82419-36-1 | IP/EP/USP | API Powder | View Product |
Tigecycline API | 220620-09-7 | IP/EP/USP | API Powder | View Product |
Frequently Asked Questions
What are Anti-Bacterial APIs?
Anti-Bacterial APIs are active pharmaceutical ingredients that inhibit bacterial growth or kill bacteria. They include fluoroquinolones that inhibit DNA gyrase and topoisomerase, nitrofurans that damage bacterial DNA, and glycylcyclines that inhibit protein synthesis. These provide broad-spectrum activity against various Gram-positive and Gram-negative bacteria.
Which anti-bacterial APIs does Holiness Pharmaceutical manufacture?
We manufacture Ofloxacin (fluoroquinolone), Enrofloxacin (veterinary fluoroquinolone), Nitrofurantoin (Anhydrous and Monohydrate forms), Tigecycline (glycylcycline for resistant bacteria), and related antibacterial agents. Products meet IP, EP, USP, or veterinary pharmacopeial standards for human and animal use.
What makes fluoroquinolones effective against resistant bacteria?
Fluoroquinolones work by inhibiting bacterial DNA gyrase and topoisomerase IV, essential enzymes for bacterial DNA replication. Their unique mechanism, broad-spectrum activity, excellent tissue penetration, and concentration-dependent killing make them effective against many resistant bacteria. However, resistance is increasing, making judicious use critical.
Do you manufacture veterinary-specific antibacterial APIs?
Yes, we manufacture Enrofloxacin, a veterinary fluoroquinolone used extensively in livestock, poultry, and companion animals. It's not approved for human use but is critical in veterinary medicine. We maintain separate manufacturing areas and provide veterinary-specific documentation supporting animal health product registration.
What is Tigecycline and when is it used?
Tigecycline is a glycylcycline antibiotic effective against multidrug-resistant bacteria including MRSA, VRE, and extended-spectrum beta-lactamase producers. It's reserved for complicated infections when other antibiotics fail, making it a critical last-line option. We manufacture to strict specifications for this important therapeutic agent.
How do you ensure chiral purity in fluoroquinolone APIs?
Fluoroquinolones like Ofloxacin exist as racemates or single enantiomers. We use validated chiral HPLC methods to ensure enantiomeric composition meets specifications. For racemic drugs, we control the ratio of enantiomers. For single enantiomers like levofloxacin, we ensure >99% enantiomeric purity for maximum efficacy.
Why does Nitrofurantoin have different hydrate forms?
Nitrofurantoin exists as anhydrous and monohydrate forms with different properties. Anhydrous form has faster dissolution suitable for immediate-release formulations. Monohydrate form is more stable and commonly used for sustained-release formulations. We manufacture both forms to IP and USP specifications for different formulation needs.
How do you support antimicrobial stewardship with your products?
We ensure consistent high-quality APIs that maintain potency, provide comprehensive stability data, support proper dosing to prevent resistance development, participate in quality surveillance programs, and promote responsible use through education. We're committed to preserving antibiotic effectiveness through quality manufacturing and stewardship support.