Vaccine formulations facility at Baddi

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.

Pharmaceutical Formulations facility at Baddi

The new Manufacturing facility for pharmaceuticals formulation ( tablets, hard gelatin capsules,
ointments and syrups) at Baddi was commissioned during April 2006. This world class facility
complies with regulatory requirements of US FDA, UK MHRA, MCC (South Africa), WHO and
other international standards.

A new pharmaceutical formulation facility of ‘ soft gelatin capsules’ at Baddi Complex was
inaugurated in July, 2006. The manufacturing facility for herbal formulations and anti-TB drugs
has also been added in Baddi complex.

The company plans to manufacture its patented products scheduled to be launched in developed
markets at its new Baddi formulation facility.

Vaccines Formulation facility in New Delhi

Vaccines formulation facility in New Delhi is a WHO cGMP approved facility with WHO Pre-
qualification for Oral Polio and Recombinant Hepatitis B Vaccines. The facility has been
designed, constructed and maintained to suit production of vaccines following Good
Manufacturing Practices. With a built up area of more than 50,000 sq ft. it has three vial filling
lines - two lines dedicated to Oral Polio Vaccines both Trivalent & Monovalent and one line
dedicated to Hepatitis B & Combination Vaccines. Provision has also been made for a separate
filling line for pre-filled injection devices. Also any injectable preparation can be filled in vials.
The Injectable Vaccine facility is also expected to be WHO pre-qualified for Combination
Vaccines during the current fiscal.

Bulk Vaccines facility at Lalru, Punjab.

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 (Ecovac, Easy Four and Easy Five)
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.