Pharmaceutical Formulations Facility (Baddi
- State of art cGMP facility with approvals from
global regulatory authorities viz. US FDA, EU
agencies, ANVISA, TGA and many other agencies
||3 USFDA Audits cleared
||Audit from BfArM Germany cleared
- 161 products approval received from 14 countries Solid Dispersion Technology
- Maintain high standards of manufacturing by
using state of art GMP compliant machines like
Sejong for tablet compression, BQS for packaging
- Equipped for: Bi-layer tablets,
Tablet-in-Tablet, Mini-tablets, Complex Sustained
release coatings and Delayed release coatings.
- Oncology injectable facility is equipped for
Conventional, Nano particular, Liposomal,
- Capability to manufacture high volumes as well
as small volumes as per market need
Bulk Vaccines Facility (Lalru, India)
Recombinant Bulk Vaccines facility has been located, designed, constructed, adapted and maintained for production of Recombinant Hepatitis B Bulk Vaccine with Cuban Technology and other biotechnology based products following current Good Manufacturing Practices (cGMPs) prescribed by WHO and the US FDA. Recombinant Hepatitis B Bulk Vaccines and Antigens are produced at this plant.
This facility received the Pre-qualification for the Hepatitis B Vaccine from WHO. This was followed by a firm order to supply 30 Million Pediatric doses of Hepatitis B Vaccine over a period of next three years.
During the year under review, this facility has adopted and successfully scaled-up the technology to manufacture the Polysaccharide based vaccine for Haemophilus influenza type b (Hib). This molecule will to be used in Combination vaccines after conjugation with Tetanus Toxoid (TT). Phase I, II and III trials for this molecule have been successfully completed in India.
To meet the ever increasing demand of the vaccines and to have backward integration; Panacea Biotec has added one dedicated facility to manufacture Tetanus Toxoid at its Lalru Unit which will be used for the manufacturing of combination vaccines (Easy Five
TT) as well as Haemophilus influenza type B conjugated vaccine (HIB-TT).
The construction of second plant has been initiated for the manufacturing of bacterial vaccines (Diphtheria Toxoid (DT), whole cell pertusis (wP) and acellular pertusis (aP)). Both the plants have been designed and constructed following cGMP guidelines which will comply with the regulatory guidelines of WHO (Geneva), USFDA and Schedule M.
The scale up of the manufacturing of Tetanus Toxoid has been successfully completed in the newly constructed facility. Standardization of the manufacturing process for individual component of DPT group of vaccine at small scale has also been completed and will be scaled up as soon as the manufacturing facilities are ready.