biopharmaceutical manufacturing, new stuff!!!

Indian companies like Biocon, Bharat Biotech, Biological E, Serum Institute and Shantha Biotechnics have world-class facilities for biopharmaceutical manufacturing. Earlier there was some reluctance to award contracts to Asian biopharma manufacturers because of concerns of IP and regulatory compliance. But now some of the Asian countries are changing and becoming very competitive in biopharma manufacturing. "Indian firms are expanding and scaling up manufacturing capacities to become global players and the West is increasingly becoming comfortable with the IP, quality, regulatory filings and the infrastructure here," said Gautam Das, COO, Syngene.

Shasun Chemicals, Suven Life Sciences, Strides Arcolabs, Jubilant Organosys, Orchid Pharmaceuticals and many other large Indian companies have started undertaking contract manufacturing of APIs as part of their additional revenue stream. Top MNCs like Pfizer, Merck, GSK, Sanofi Aventis, and Novartis are dependent on Indian companies for many of their APIs and intermediates.

Today Indian pharma companies have upgraded their existing plants or built new plants which are not only GMP compliant but also approved by international drug authorities. Many mid to large-sized ones have achieved GMP approval of highly regulated markets such as the US, Europe, Australia, Latin America and Canada. The most stringent, the USFDA approval is distributed between large and mid size companies.

India triumphs in having maximum number of USFDA approved plants after the US. India has over 80 USFDA approved plants and all comply with WHO GMP. India is expected to have 30 percent more USFDA plants by 2008. The large portion of this increase will be shared by mid size pharma companies. Most of the companies are upgrading and building new facilities as per USFDA standards. Apart from Andhra Pradesh and Gujarat, Himachal Pradesh is the next favored state for setting up manufacturing plants. India comes fifth in terms of API manufacturing. It has established itself as low cost and high quality API production country. With product patent regime in its second year and several products expected to go off patent in the next 2-3 years, India is well positioned to capture the outsourcing opportunity.

With India emerging as a cost competitive outsourcing base for global majors, Jubilant Organosys, an integrated pharmaceutical and custom research and manufacturing services company, intends to be the preferred partner for custom research and manufacturing to global leaders in the pharmaceuticals and agrochemicals industry.

Jubilant Organosys recently signed a multi-million dollar long-term agreement with Syngenta for the supply of pyridines. The new contract will begin from early 2008 and it will cover an extension period of up to five years, during which Jubilant will continue supplying the products to Syngenta.

Recently Jubilant expanded its production capacity for pyridines and picolines to 42,000 TPA and this contract with Syngenta would significantly improve the use of the additional capacity. With this multi-year contract and increased capacities, Jubilant emerges as the largest player in pyridines worldwide.

Jubilant Organosys have also acquired US-based Hollister–Stier Laboratories LLC for $122.5 million. This is said to be the largest overseas acquisition in contract manufacturing sector by an Indian company. The acquisition significantly strengthens Jubilant's global CRAMS business via entry into the high barrier injectables segment.

Hollister is an excellent strategic fit for Jubilant, as it augments the company's growth in the CRAMS business globally. This acquisition provides Jubilant with a platform within the fast growing injectables contract manufacturing segment.

The company had signed annual contracts worth $60 million. The contracts form part of the company's order book for the calendar year 2007. The contracts have been finalized with some of the leading global life sciences companies in the US and Europe. In addition to these annual contracts, the company as part of its normal business also executes half yearly, quarterly and monthly contracts and spot sales.

The company will also focus on twin strategies of investments in innovation and world-class manufacturing facilities. Currently, Jubilant is in advanced talks with other global life sciences companies and is confident of signing several other contracts for CRAMS over the next few months.