The Indian pharmaceutical companies are emerging as a powerhouse for active pharmaceutical ingredients (API) production. Indian API manufacturing industry is the third largest in the world and is expected to make sales of $4.8 billion by 2010, an average yearly growth rate of 19.3 per cent. The country is also poised to emerge as a global competitor. In fact, growth rates of API export sales, especially towards highly regulated markets like US is on the rise. Indian API manufacturers are expected to increase its presence in the regulated markets soon.
Indian API manufacturers are well organised for supplying documentation to the client for drug master files (DMFs) and good manufacturing practice (GMP) compliance. The country also tops in DMF submissions and has the largest number of US Food and Drug Administration (FDA) approved plants outside US.
Many multinational pharma companies have commissioned their research and development centres in India. The Indian companies have successfully enhanced their ability to launch new products by filing more DMFs and ANDAs in the highly regulated markets. Process innovations and new drug delivery systems have helped domestic drug companies to gain a foothold in the global generics market and move up the value chain. This has brought in a new confidence into the sector making it respond to the new market with enthusiasm. Every pharma company is expanding its therapeutic outreach in the domestic as well as in the international market.
The major Indian pharma companies like Ranbaxy Laboratories, Lupin, Shasun Chemicals, Orchid Chemicals, Aurobindo Pharma and Sun Pharmaceutical have strong market presence in the major therapeutic areas. Other companies like Ipca Laboratories, USV and Sharon Bio Medicine have significantly scaled up their R&D spending in the last few years. Members of the India Pharmaceutical Alliance (IPA), which comprises of most of the research-oriented Indian companies, have increased their spending on research four times over the last four years.
Ranbaxy: Consistent growth in API
Over the years, Ranbaxy's API business has grown consistently. In a macro environment of extra ordinary competition and challenges, the API division has moved from strength to strength. The company supplies world class API's to leading generic companies in more than 50 countries. The current focus of the business is on the regulated markets with Europe and USA being the mainstay. Supplementing the sales achieved in these territories is the excellent performance in China, select markets of Asia, Far East and Latin America.
Ranbaxy has over 50 products covering a wide therapeutic range such as cardiovascular, anti-infectives, anti-ulcerants, anti-diabetics, anti-depressants and anti-virals in its API portfolio.
The objective of this business is to provide total solutions to the customer with regard to API starting from samples and trial quantities to regulatory assistance required for registration and regulatory compliance. Ranbaxy has five API facilities in India located at Punjab. The manufacturing facility at Mohali, Punjab is engaged in the production of APIs, primarily semi synthetic penicillins, flouroquinolones and bulk cephalosporins. The manufacturing facility at Toansa, Punjab is engaged in the manufacturing of APIs, mainly anti-biotics, anti-allergens and anti-ulcerants.
Ranbaxy's API division is an ideal partner for APIs due to its GMP culture, FDA/MCA approved plants, good quality, regulatory and R&D support, robust pipeline, good therapeutic width, differentiated products providing early market entries, well grounded patent opinion, preemptive capacity planning, commitment through long term contracts, speed to market and customer orientation.
Aurrobindo: Running on APIs
One of the largest API manufacturers in Asia, Aurobindo Pharma has commercialised over 100 APIs. It has emerged as a vertically integrated global pharma company poised for a rapid growth. Immense capabilities and uncompromising product quality underline the core competence of the company. Its products are spread over six major areas encompassing anti-biotics, anti-retro virals, CVS, CNS, gastroenterologicals and anti-allergics.
Its competitive advantages are large portfolio of approvals, global standard R&D efforts and a cost efficient mega manufacturing environment complying with US FDA and EU authorities.
Aurobindo's R & D strengths lie in developing intellectual property in non-infringing processes and resolving complex chemistry challenges. In the process, Aurobindo develops new drug delivery systems, dosage formulations and applies new technology for better processes. Total quality management is the very essence of Aurobindo Pharma. The company is subjected to scrutiny with cGMP compliance, validation, stability studies, documentation, safety, health and environmental issues. This steadfast adherence to TQM has been highly rewarding and ensures that all products are truly world class. The company has filed 22 patents and currently it holds four patents. It has also filed 20 more DMFs in US and EU. In its R&D centre, the company has 260 scientists and willing to add more. The company has four formulation sites and fifteen modules in solids, liquids and sterile dosages.
In global markets, the company will retain and enhance cost efficient quality leadership in semi synthetic penicillins, cephalosporins, newer anti infectives and lifestyle disease drugs. The company will obtain regulatory approvals by filing DMFs and Abbreviated New Drug Applications (ANDA) in lifestyle disease drugs and sterile and non-sterile cephalosporins.
The long-term growth strategies being put in to action include:
■ Developing a broad portfolio of DMFs and ANDAs through non-infringing processes and intellectual properties
■ Becoming a significant player in the generics market, especially in the regulated markets
■ Manage cost efficiently in its mega-manufacturing environment approved by US FDA and European regulatory authorities, enhancing the attractiveness of Aurobindo Pharma to alliance partners
■ Resolve complex chemical challenges and offer advanced drugs to the global markets
Lupin: Home to quality APIs
Lupin's API business is based on cost, quality and capacity leadership. The company's major therapeutic areas are anti-TB, cepholosporins (both orals and injectables), ace inhibitors, statins and prils. Lupin is in the process of establishing itself as a major global force in NSAID, cardiovascular drugs and nutritional supplements. It also makes and markets API advance penultimates.
Ipca: Exporting APIs
The Mumbai-based largest manufacturer and exporter of APIs, Ipca Laboratories is backed by more than 27 years of expertise in pharmaceutical manufacturing. Ipca's APIs are well accepted all over the world and are currently exported to the regulated as well as to the non-regulated markets.
Ipca currently manufactures and markets about 65 APIs. Another 25 APIs are under various stages of development. Major therapeutic areas covered in API business are cardiovasculars, anti-malarials, pain management and steroids.
Ipca has leadership position in few APIs like chloroquine phosphate, atenolol, hydroxychloroquine sulphate, amodiaquine etc. It has three API manufacturing facilities at Ratlam, Indore and Aurangabad with a combined capacity to produce about 3500 MT of APIs per annum. The Ratlam API manufacturing facility is approved by regulatory authorities from Europe, USA and Australia.
Talking to Pharmabiz, A K Jain, executive director, said, "We have drawn a detailed plan of expansion for the next two years. Currently, we are investing Rs 70 crore for setting up two new API facilities. Simultaneously, we are investing Rs 5 crore for setting up additional lab at our research and development centre. Our new API facility will mainly focus on the hydrocloroquinsulfate and metformin for the anti-malaria and anti-diabetic segment. Every year we are producing 10-12 new APIs for the domestic market".
Ipca manufactures and exports APIs across the globe. API exports were about Rs 2113 million in 2006-07. Domestic API business was Rs 707 million. Ipca has 23 US DMFs and 12 European EDQM filings. About 50 per cent of Ipca's formulations business is backed by its own APIs. Balance APIs required for formulations manufacturing are outsourced by the company.
The company's research is leading to the generation of non-infringing routes for APIs drug intermediates and intellectual property. Ipca has highly qualified and experienced groups of people capable of handling patent-related issues, which include various aspects of patenting and patent evaluations.
USV: An API partner
The Mumbai-based leading pharma company USV, has an aggressive API development programme. The company strives to be perceived as a reliable, responsive and competent API partner by its customers. Currently, it holds 21 APIs, and 11 APIs in various stages of maturity and a development programme of 7 new APIs. USV is a leader in anti diabetics and cardio vascular APIs.
Talking to Pharmabiz, Prashant Tiwari, managing director, said, "We are the world leaders in metformin and glimepiride. We also do not restrict ourselves in other therapeutic areas and have a presence in various other diverse areas like oncology and ophthalmology. We have a plant capacity of 5000 MT / annum of metformin, about 4 MT of glimepiride and a host of other APIs which can be manufactured at our Chiplun site. We market our products in US and European markets. Till date, we have filed 22 DMFs."