Spotlight

The speciality specialist

Ajanta Pharma has moved up the value chain to become a 'speciality specialist company' in their sub-therapeutic areas. Suja Nair explores their future plans

"All products launched by Ajanta Pharma in domestic or overseas market are developed by our scientists. We have launched 45-50 products in the Indian market in last two years and are looking to file more than 15 ANDAs" - Yogesh Agarwal Managing Director Ajanta Pharma

Ajanta Pharma was incorporated in 1973 as a pharma repackaging proprietary concern. Ranked as one of the fastest growing pharma companies by ORG-IMS since the last two years, Ajanta has moved up the value chain to become a research-oriented, speciality focused company. With a growth rate of 30 percent, thanks to a strong exports thrust, Ajanta today has a presence in more than 52 countries, with exports contributing more than 50 percent of its turnover. After conquering unregulated and semi-regulated markets, Ajanta is now all set to enter US market when it files its first Abbreviated New Drug Application (ANDA) filing in the current year. The company is also steadily increasing its R&D expenditure with this goal in mind.

Challenges bypassed

Before concentrating on formulations, Ajanta was a player in the generic market. Rather than doing everything on a smaller basis, the company wanted to concentrate on one field and to be the best in it, and therefore, decided to focus on formulations. The decision came with its own challenges. "The biggest challenge that we have faced in the last three years was to transform Ajanta from a non-speciality company into a speciality company. It took a lot of convincing to make people believe that we could do it. First we had to build trust among our own people. But the most difficult part was to convince others, especially to register this (changed focus) with the medical fraternity. It required a lot of teamwork, dedication and self belief to achieve and reach where we are today," recollects Yogesh Agarwal, Managing Director, Ajanta.

Expansion with 'Project Victoria'

First phase of the Ajanta Pharma R&D facility at Kandivali, Mumbai

With a view to foray into the regulated market, Ajanta is investing Rs 100 crore for the expansion of its R&D and manufacturing facility. The company's manufacturing facility, located at Paithan near Aurangabad, adheres to WHO and cGMP standards. Code-named 'Project Victoria', this project is slated to be the stepping stone for Ajanta's entry in the regulated market.

According to Agarwal, of the total planned investment, Rs 40 crore would be put in R&D and the remaining would be used to set up a new manufacturing unit in the same campus as the existing unit. The new facility will have capabilities for dry dosage forms of tablets and capsules and is being built to meet US FDA standards. The project is in the process of completion and the company is expecting an FDA inspection by mid May this year, with its approval expected by July. The expansion plan is being funded by internal accruals and some part is being covered by loans from bankers, reveals Agarwal.

R&D focus

Ajanta's R&D centre is equipped with state-of-the-art, medicinal chemical laboratories and modern equipments and utilities, suitable for international markets. It focuses on formulation development and new drug delivery systems (NDDS). It has already commissioned the first phase of its new state-of-the-art R&D facility spread over 15,000 sq feet at Kandivali in Mumbai with a team of 130 scientists. And by year end, the second phase spread over 20,000 sq feet area will be operational. A total investment of Rs 225 million has been made in the first phase while further investment of Rs 100 million is planned in the second phase. The company will also be increasing its pool of scientists to man these new facilities.

Agarwal says, "Our infrastructural capabilities cover three main domain areas formulation development, analytical method development and a world class quality assurance section, which monitors and validates work done by our centre." Most scientists at the R&D centre have advanced degrees, some with overseas experience as well.

Creating a niche

Ajanta is a speciality focused company and its products enjoy strong market position in sub-therapeutic areas like ophthalmology, dermatology, cardiology, ENT, paediatric, etc. Its manufacturing capability includes a wide range of therapeutic products covering segments like anti-retrovirals, anti-malarials, cardiovascular, dermatology and ophthalmology. They also market over the counter (OTC) products in many international markets that include some nature-based remedies. Agarwal adds, "All products launched by Ajanta Pharma in domestic or overseas market are developed by our scientists. We have launched 45-50 products in the Indian market in the last two years and are looking to file more than 15 ANDAs." Its formulation development infrastructure supports development of finished dosages in a wide format of immediate release as well as sustained release and controlled release technologies in various dosage forms. It has been able to launch products with enhanced release profiles to ensure better treatment compliance and dosage convenience.

Over the years, Ajanta has focused on developing new formulations, and of the 83 products launched by the company, more than ten products were first-to-market products that have a very strong position in the sub-therapeutic area. "We have been launching unique products over the years and one of the recently launched products is 'Vaniza'. We are the first company to bring this anti-scar speciality product to India," avers Agarwal.

Ajanta has also licensed this product to a Taiwanese company, Orient Europharma. Under the agreement, Ajanta will transfer the product technology to the Taiwanese company, who will manufacture and market it under license from Ajanta. "We have always given strong emphasis to the service and quality of our products. We have been approved to supply medicines to various government institutions and are preferred as a certified supplier to many big institutions and voluntary organisations like Medicines sans Frontiers (MSF) and Pharmaciens sans Frontiers (PSF), within and outside the country," points out Agarwal.

Tie-ups

Apart from the Orient Europharma agreement, Ajanta had other major alliances in the last year. To name a few, Ajanta had an in-licensing agreement with Prollenium Medical Technologies, Canada, under which it got exclusive marketing rights for Prollenium's dermal filler 'Revanesse' in India.

Apart from these strategic alliances, Ajanta has also entered the niche ENT and paediatrics segments through a new division 'Aureus'. Agarwal adds, "We already have a presence in Brazil, Mexico and have about two to three products approved and are planning to file around 12 products in each of these countries. The tie-up in Brazil is with a subsidiary of a company, Arrow, called Danks Flama, which is a very sizeable $1.5 billion global generics player."

Strategies

Agarwal points out that there are hardly eight to ten Indian pharma players focusing on the global formulations market, and with its foray into regulated markets, Ajanta would join this league. Outlining the company's strategy, he states, "We develop niche products where competition is less. The main strategy that we are adopting is to go for controlled release and extended release products, which have three to four players instead of immediate release products where the competition is much fiercer."

Further, he says that though there are comparatively less players in this area, the challenges are not any less, as they have to deal with the double challenge of not only developing but also manufacturing a product. It requires superior R&D and manufacturing skills to go beyond the API stage, into extended release formulations, and that is the main reason why there are not many players in this field.

Another strategy used by Ajanta is to leverage its best by partnering with companies with key strengths in complementary areas. This dual strategy has served the company well so far. With an expansive and self-operated global marketing network, Ajanta seems to be on the right track, following its stated vision of 'Enterprism'-the art of creating opportunities and optimising them.

suja.nair@expressindia.com