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, Lyophilized products
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.

Vaccine Formulations Facility (Baddi, India)

The new Greenfield construction Vaccine Formulation plant (VFP) has been introduced in Baddi – Himachal Pradesh. The plant has been commissioned with several filling lines for bacterial and viral vaccines complying with WHO, cGMP norms for liquid Vaccines in pre-filled syringes, liquid & lyophilized Vaccines in vials. The total production capacity of this facility is one billion doses per annum.

The unit will increase our production capacity of vaccines substantially in scale and size. It would significantly improve our market presence globally and augment our plans to become a global leader in this field. 

The three-story production block is spread over approx. 2800 M² construction area at each floor. The production floor has non-metallic Modular Panels for partitioning in the critical area having walk able ceiling for easy maintenance of supply ends for utilities, clean air and lighting system. The plant also has a two-story block of Warehouse-cum-Cold Storage facility admeasuring approx. 2500 M² on each floor. 

Vaccines Formulation Facility (New Delhi , India)

Vaccines formulation facility in New Delhi with a built up area of more than 50,000 sq ft.  From this facility over 9.7 billion doses of safe and efficacious OPVs to Government of India and through UN agencies in India and abroad which has been a major contribution of Panacea Biotec to Global Polio Eradication Initiative (GPEI) and Eradication of Polio from India