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Home , Panacea Biotec

PANACEA BIOTEC HUMBLE

BEGINNING... GREAT FUTURE

2 | Make In Express Pharma anacea Biotec is masses. In 1989, a India’s one of the manufacturing plant was set up leading health in under the name of management Radicura Pharma. company. Way In 1989, a pharma back in 1927, the formulations plant was set up in company started , under the name of of as a pharmacy Panacea Drug. In 1993, Panacea shop in Sialkot, now in Pakistan. Drugs and Radicura Pharma InP 1927, the family shifted to Delhi were merged to form Panacea and put up the first pharma plant Biotec. The company went public in Delhi. In 1983, it collaborated in 1995. With the money from with an Italian company called IPO, more sales staff were hired Sclavo, which later on was and products were introduced. acquired by Chiron and then by Between late 90s and early Novartis. The company initially 2000, a collaboration was held started with its their various with Cuba-based Heber Biotec products and started marketing and a manufacturing plant was them. In 1984, Panacea Drug was set up at Lalru, Punjab for set up with a commitment to hepatitis vaccine. In 2005, the make novel and innovative world’s first medicines affordable to the was developed in collaboration Dr Rajesh Jain, Joint Managing Director, Panacea Biotech

Express Pharma Make In India | 3 with Chiron, which was launched MANUFACTURING FACILITIES PHARMACEUTICAL in the same year. Also in 2005, the The company’s manufacturing company raised $100 million from facilities for and MANUFACTURING SECTOR the foreign convertible currency pharma formulations were bonds to fund expansion and put situated at Lalru and Baddi. It NEEDS GREATER up more R&D centres. has state-of-the-art integrated The team at Panacea Biotec facility for drug substance of ASSISTANCE IN TERMS OF led by Dr Rajesh Jain crafted the vaccines and biosimillars at ‘Vision 2020’. The vision ‘To Lalru and were set up in AVAILABILITY OF FINANCE, create Panacea Biotec as one of compliance with international the World’s Greatest, Largest regulatory standards including TAX INCENTIVES FOR UPTO and Most Admired US FDA, WHO-cGMP and Biotechnology Company by European Union. 10 YEARS FOR CAPACITY 2020.’ The vision covered the four perspectives of customer; PHARMA FORMULATIONS ENHANCEMENT AND finance; internal learning, Facility at Baddi growth, and innovation and The facility in Baddi became SETTING UP R&D UNITS internal processes. operational in 2006. It is Under the vision 2020, the equipped for conventional company developed 23 strategic tablets, bi-layered tablets, tablet- objectives, cascaded with in-tablet, mini-tablets, complex currently 168 strategic sustained release coatings and initiatives. The three pillars, delayed release coatings. The which lay the foundation of vision facility has been approved by 2020, are: ‘One Click’ (all National Regulatory Authority of information is available to India (NRA), US FDA, BfArM anyone with just one click), ‘Zero Germany and ANVISA Brazil Slip’ (deliver whatever you etc. The facility has faced many commit without any slips), and regulatory audits and ‘Zero Defect’ (absolutely no successfully received product defect in the quality to the approvals as under: customer). ◗ Cleared 3 audits from USFDA,

4 | Make In India Express Pharma LAKSH: Drug Discovery Research and Development Centre, Mohali Global Research and Development Centre (GRAND),

◗ Cleared audit from BfArM Vaccines formulation facility pre-filled syringe (PFS), liquid and bacterial and viral vaccine bulk Germany. The vaccine formulation facility at lyophilised vaccines in vials. The and antigens. It manufactures ◗ 161 products approval received Baddi is spread across 23 acres. It facility has also been approved by Recombinant Hepatitis B surface from 14 countries. is WHO pre-qualified for Indian NRA. antigen, Haemophilus influenzae The company has recently set Pentavalent Vaccine Easy FiveTT. type B conjugate bulk (Hib-TT) up a Cytotoxic (anti-cancer) It consists of two blocks which Vaccine antigens and diphtheria, tetanus toxoids and formulation facility at Baddi, started its operations in 2008. The biosimillars at Lalru whole cell pertussis. with two lines dedicated for facility consists of production, The company has drug liquid and lyophilised vials as quality control and quality substances, vaccine and antigen Working for ‘Make in India’ well as pilot scale up batches. It assurance, warehousing and cold manufacturing facilities with Panacea Biotec under the has filed seven ANDA with US storage facility. It has filling lines dedicated blocks for leadership of Dr Rajesh Jain lays FDA from this facility. for injectable liquid vaccines in manufacture of recombinant, a strong emphasis on ‘Make in

Express Pharma Make In India | 7 STATE-OF-THE-ART PHARMACEUTICAL MANUFACTURING FACILITY AT BADDI IS USFDA, BFARM, ANVISA CERTIFIED

India’. The company focused on chemical and biological entities develop fully liquid pentavalent biological research, NCE/NBE, high quality infrastructure, ◗ Design and development of vaccine – Easyfive (DTwP-Hep NDDS, and difficult-to-develop quality management process, new generation prophylactic and B-Hib) generics have enabled the skill development, innovation, therapeutic vaccines ◗ First to develop monovalent company to become one of the own R&D and adoption global ◗ Development of humanised OPV (Oral ) leading research institution management practices. and fully human therapeutic ◗ First to develop Bivalent OPV through its product pipeline such monoclonal antibodies. (Oral Polio Vaccine) as Nab-Paclitaxel, doxorubicin CORE STRENGTHS ◗ The company has several novel ◗ The company has launched liposomes, pentavalent vaccine, Established R&D capabilities vaccines in pipelines few of them indigenously developed Albumin pneumococcal conjugate vaccine, The company has built a strong includes Japanese Encephalitis, bound paclitaxel particles trasutizumab, recombinant R&D base over the last decade to pneumococcal, dengue formulation – PacliALL for darbepoietin etc. Panacea support its various business conjugated tetravalent breast cancer Biotec's R&D efforts are focused segments and the current recombinant vaccine, which the The company has collaborated on four major areas of research - research strengths of Panacea company is intended to launch in with leading research institutes, ◗ NCE research: Metabolic Biotec are focused on: next two to three years. academic universities and disorders, anti-infectives, CNS ◗ Drug delivery system design commercial corporations. ◗ NBE research: Autoimmune and optimisation R&D initiative includes: These efforts are sustained by diseases, dermatology, metabolic ◗ Discovery and synthesis of new ◗ Panacea Biotec is the first to dedicated R&D centres for disorders

8 | Make In India IIExpress Pharma Pharmaceutical formulation facility, Baddi, Himachal Pradesh ◗ Drug delivery research: Oral than 116 scientists, over 571 modified release, employees engaged in nanotechnology, depot production and quality injections, transdermal systems control/quality assurance and ◗ Vaccine research: New over 1,289 professionally trained generation combination and motivated employees vaccines, new prophylactic engaged in sales, marketing and vaccines (paediatric and adult) logistic activities.

STRONG BRAND PORTFOLIO QUALITYASSURANCE Panacea Biotec’s product Quality is at the core of Panacea portfolio includes highly Biotec’s business processes and innovative prescription products systems. Its manufacturing in important therapeutic areas facilities for vaccines and such as , pharma formulations comply cardiovascular disease with various key international management, organ regulatory standards like WHO transplantation, diabetes cGMP, USFDA, BfArM Germany, management, renal disease ANVISA Brazil, etc. management, , anti-osteoporosis, anti- INTELLECTUAL PROPERTY tubercular, gastro-intestinal care The company has been granted products and vaccines. 34 product patents worldwide for different products/ technologies. MOTIVATED TEAM As at the end of the year under There are around 2,748 people review, the company has filed SAMPANN: Drug delivery research and development working together to achieve the around 1,516 patent applications centre, Lalru, Punjab goal of meeting every healthcare worldwide (including 225 Indian need with a Panacea Biotec and 102 PCT applications) out of brand and service. It has more which 422 patents have been

10 | Make In India Express Pharma Express Pharma Make In India | 11 Vaccine formulation facility, Baddi, Himachal Pradesh

granted/accepted for grant generics with high barrier to ◗ ESRD Drug Suspension completed development of including six patents granted in entry. Following this strategy, the ◗ Pregabalin Modified Release several products and the Russia, China, Europe, the US company has already identified ◗ Voriconazole Modified Release company has filed 7ANDAs with and India during the year under some niche products which are ◗ Mycophenolate Modified US FDA since its first product review. currently under different stages Release was launched in the US. The company has filed over of development at its R&D The company has also 723 trade mark registration centres, these include: Growing in overseas market strategically partnered with the applications out of which 441 ◗ Cyclosporine SEDDS capsules The company has laid its future Russian Federation government have been registered including ◗ Anticancer drugs growth strategy with focus on for immunosuppressant’s such as five applications registered nanoparticles, depot injection, the regulated markets of the US Panimun Bioral and Mycept. It during the year under review. liposomes and Europe. The company will introduce brand Pangraf In addition, the company has ◗ Urology drug depot injection launched its first product Tacpan (Tacrolimus) in the Russian also filed 515 International Trade ◗ Antifungal drug (Tacrolimus) in 2011 in Germany market. Mark applications out of which ◗ Immunosuppressant Modified and it has now become the The company is in the final 291 have been granted. Release second largest generic in stages of registration and ◗ Antiemetic Nanoparticle Oral Germany. It has also launched approval in key markets like Great future ahead Formulation Tacrolimus in the US in Egypt, South Africa & Saudi The company’s strategy is to The company is also developing December 2012. Arabia (GCC). develop and launch selective 505(b)(2) products for US, these Over the last few years, the portfolio of difficult to develop include: company’s R&D centres have

12 | Make In India Express Pharma ACHIEVEMENTS

1984 Incorporated as 2011 Supply of over 45 million UNICEF over last 15 years. Panacea Drugs doses of Pentavalent Vaccines (EasyFive) to UNICEF, GAVI for 2014 Long-term supply contract 1989 Production of supply in over 31 countries with WHO for supply of Pentavalent pharmaceuticals and vaccines vaccine (Easyfive TT) for the period commenced 2011 PacliALL – 1st nanoparticle of 2014-16 affordable Albumin-based Paclitaxel 2003 Pre-Qualification of Oral Polio anti-cancer formulations launched in 2014 Strategic alliance with Apotex, Vaccine (OPV) by WHO India which received Biospectrum Canada for marketing PBL drugs in Product of the Year Award North American markets. 2005 Launch of “EasyFive”: 1st fully 2012 Collaboration with PT liquid pentavalent vaccine in the BioFarma, Indonesia 2014 Strategic collaboration with world Rising Pharmaceuticals. USA, for 2012 Launch of pharmaceutical marketing PBL drugs in US 2006 Collaboration with formulations in the US market. Netherlands vaccine Institute (NVI) for introduction of Inactivated Polio 2014 Polio eradication: Panacea Vaccines (IPV) Biotec has played a key role in polio eradication in India by 2008 WHO Pre-Qualification for supplying over 10 billion doses Pentavalent Vaccine (EasyFive) OPVs to Government of India,

Express Pharma Make In India | 13