BioHIB-Haemophilus influenzae type B conjugate vaccine
Product Overview
| Generic Name | BioHIB-Haemophilus influenzae type B conjugate vaccine |
| Brand Name(s) | BioHIB® |
| Category | Vaccines |
| Form | Lyophilized powder for reconstitution/injection (0.5 mL vial) |
| Strength | 0.5 mL per vial; |
| Therapeutic Class | Vaccine (bacterial vaccine) |
| ATC Code | J07AG01 |
Manufacturing & Regulatory
| Manufacturer | Bharat Biotech International Ltd |
| 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 | 12-18 months |
| Storage | 2–8 °C; do not freeze; use within 24 hours post‑reconstitution |
| Incoterms | Ex-Works Mexico |
| Lead Time | 4–6 weeks, depending batch availability |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Certificate of Analysis provided per batch by Bharat Biotech |
| SDS-Safety Data Sheet (PDF) | Standard SDS available for PRP–TT vaccine upon request |
| CTD Summary (PDF) | export summary available on request, proprietary |
Special Notes
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. Contains purified PRP polysaccharide conjugated to tetanus toxoid (PRP–TT), derived from an Indian Hib strain (CS‑68). Administer intramuscularly at 6, 10, 14 weeks of age.