Haemophilus influenzae type B conjugate vaccine
| Product Overview | |
| Generic Name | Haemophilus influenzae type B conjugate vaccine |
| Brand Name(s) | BioHIB® |
| Form | Lyophilized powder for reconstitution/injection (0.5 mL vial) |
| Strength | 0.5 mL per vial; |
| Therapeutic Class | Subunit (capsular polysaccharide–protein conjugate) vaccine |
| ATC Code | J07AG02 |
| Manufacturing & Regulatory | |
| Manufacturer | Bharat Biotech International Ltd |
| Country | India |
| GMP Compliance | WHO-GMP certified |
| DMF/CEP | Manufacturer-specific, not public |
| COFEPRIS | Pending |
| Free Sale Certificate | Available per batch upon request |
| Logistics & Export | |
| MOQ | 200 vials for export |
| Shelf Life | 24 months |
| Storage | 2–8 °C; do not freeze; use within 24 hours post‑reconstitution |
| Incoterms | FOB Indian port (Mumbai) or EXW Hyderabad |
| Lead Time | 2–6 weeks, depending batch availability |
| Documentation | |
| Certificate of Analysis (COA) | Certificate of Analysis provided per batch by Bharat Biotech |
| SDS | Standard SDS available for PRP–TT vaccine upon request |
| CTD Summary | export summary available on request, proprietary |
Description
Indications & Usage: BioHIB® is indicated for active immunisation against Haemophilus influenzae type b (Hib) diseases, including meningitis, pneumonia, epiglottitis, and bacteremia, particularly in infants and young children aged 6 weeks–4 years. It contains purified PRP polysaccharide conjugated to tetanus toxoid (PRP–TT), derived from an Indian Hib strain (CS‑68). Administer intramuscularly per WHO/IAP schedules, typically at 6, 10, 14 weeks of age. Adverse events are generally mild: injection-site reactions, fever, irritability, loss of appetite. Store at 2–8 °C; reconstitute before administration and use within 24 hours.
