The pharmaceutical industry at Baddi in Himachal Pradesh, considered to be the largest pharmaceutical hub in the country with more than 200 companies, is turning to be a safe haven for export activities with several of the leading players increasingly embracing GMP norms to meet export criteria.
According to industry sources, companies located at Baddi, once focused primarily on the domestic market, are now rapidly turning their attention to the export market in order to fully exploit the tax holiday. Several leading players in the country such as Panacea Biotec, Dabur, Dr Reddy's, Glenmark, Cipla, Torrent, Wockhardt, Unichem, Alkem, Nicholas Piramal, and Johnson & Johnson have their manufacturing facilities at Baddi. All these players have set up their manufacturing facilities at Baddi with world-class infrastructure facilities meeting cGMP norms and other regulatory requirements with a view to manufacture for the export market.
Panacea Biotec
The Delhi based Panacea Biotec, one of the leading players, which is present in Baddi, recently commissioned a new vaccine manufacturing facility with an investment of Rs 100 crore. 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 and lyophilized vaccines in vials. The total production capacity of this facility is one billion doses per annum and the main focus of the plant is export oriented manufacturing.
Company chairman, Soshil Kumar Jain, says, "The new world class facility has been designed, constructed, and approved for the production of filling lines of bacterial and vital combination vaccines. 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 walkable 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.
Glenmark
The Mumbai based Glenmark Pharmaceuticals, one of India's leading research-led, integrated pharmaceutical companies, recently received approval from MHRA of UK for its state-of-the-art semi-solids (ointments & creams) manufacturing plant at Baddi. According to the company, it will enable them foray into supply of creams and ointments in Europe soon.
The Baddi plant, which has already received GMP approval from TPD, Canada, is well on course to receiving USFDA approval in the near future, which would enable Glenmark to enter the niche segment of semi-solid dosages in most of the regulated markets of the world.
Mr Glenn Saldanha, CEO & MD, Glenmark Pharmaceuticals says, "The approval from MHRA, UK will provide further impetus to our current expansion efforts in the European region. Our plant at Baddi has been built to the international standards and has been producing batches for filing in Europe and the US. Glenmark has been constantly upgrading its manufacturing facilities to efficiently meet the anticipated demands of the global markets and we look forward to the US FDA approval for Baddi as the next milestone."
Glenmark's facility at Baddi is fully commissioned with more than $52 million worth of production coming from this facility. Baddi presently supplies Glenmark's Indian requirements and has produced batches for filing in the US and Europe. It hopes that the Baddi facility will break-even in its first two years of operation.
Dabur
Dabur, the leading player in the oncology segment, is present at Baddi with two-world class manufacturing facilities, one of which is already in operation. The new facility at Baddi, with the production capacity of 60 million capsules per day and project work of which is in progress, is expected to commence commercial operation by the beginning of next year. According to the company, both the facilities at Baddi have been set up as per global regulatory requirements. The plant has been inspected and approved by the regulatory agencies of Hungary, Belarus, Jordan and Zimbabwe, besides having WHO - cGMP approval.
Torrent Pharma
The Ahmedabad based Torrent Pharmaceutical Ltd set up state-of-the-art facility with an investment of over Rs 130 crores at Baddi and it commenced operation November 2005. It has a capacity to manufacture 3600 million tablets, 400 million capsules and 18 million Oral Liquid bottles, per annum. Other operations at the plant have been streamlined, with the critical machines and operations already functional at the plant.
The Plant has been approved by ISO/IEC 17025 in May 2006. The chemical and biological testing Labs have been accredited by NABL and the QC Lab attested by NABL to be in accordance with the international standards.
Cipla
Cipla, the second largest pharmaceutical company in India in terms of retail sales, set up its state-of-the-art facility for manufacture of formulations at Baddi in 2005. According to reports, the company has expanded its facility at Baddi with a view to manufacture for the export market.
Unichem
The Baddi plant of Unichem Laboratories Ltd is a state-of-the-art pharmaceutical manufacturing unit and it houses manufacturing facility for different formulations of beta lactam range of antibiotics. It has the approvals of world's premier regulatory bodies such as WHO, MCC - South Africa and MHRA-UK. It has a production capacity of 225 million capsules, 20 million vials, 48 million tablets, and 6 million dry syrup per annum.
As per industry reports, medium and small players, who has manufacturing facilities at Baddi, also set up their manufacturing facilities as per the regulatory requirements. Some of them are in the process of upgrading their facilities with a view to enter export market. The Delhi-based Maxtar Bio-Genics is one such company, which commenced operation at Baddi this year, vigorously planning to enter the export market in the near future. According to the company, it has already received ISO 9001:2000 certification and it has applied for the WHO certification and is expecting the approval by December this year. According to a company source, once it receives the WHO GMP certification, it will foray into export segment.