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Hyderabad , Dec. 12

GLAND Pharma Ltd (GPL), the city-based injectables manufacturing company with the German collaboration, has received the approval of the US Food and Drug Administration (USFDA) for its injectables facility here.

At a press conference here on Friday, the GPL Chairman, Mr P.V.N. Raju, said the approval was obtained for some of the products manufactured by the company for its US-based partner, Apotex Corporation, the largest Canadian-owned pharmaceutical company.

Stating that the USFDA team inspected the facility in September, Mr Raju said the team finding the facility as acceptable marked a culmination of the company's efforts during the last five years.

GPL's long-term goal was to be an important player in the global generics business worldwide and to occupy a niche position as an injectable products manufacturer.

The GPL facility currently hosts a pre-filled syringes line, two vial lines and an ampoule line.

The company has been exporting to several countries in the near regulated markets.

During the last few months, the company was audited and approved by various regulatory bodies such as ANIVISA of Brazil, NAFDAC of Nigeria, MOH of Uganda and Yemen, Mr Raju said.

"Our focus has been on export markets and we seek to leverage our world-class injectable manufacturing capabilities. This USFDA approval is a key milestone that will help the company in achieving rapid export growth driven by the regulated markets. Our programme for generic injectables will now firmly launch the company into the fast-growing $40-billion generics market in the US and Europe. We expect this to lead to revenues of about $100 million over the next three years," Mr Raju said.

Stating that the company had decided to focus on contract manufacturing for the players in the regulated markets, he said GPL was currently in negotiations with several global majors for entering into contract manufacturing agreements. The company is also in the process of registering many of its products in several countries.

In view of the increasing opportunities in the regulated markets, the company has initiated steps to strengthen its manufacturing base and tap the regulated markets. Having estimated a funds requirement of around Rs 100 crore over the next three to four years, the company is currently debating over the means of finance, the GPL General Manager (Corporate Finance), Mr Y.V.G. Krishna Rao, said.

The options include going into for an initial public offer, placing equity privately and raising institutional debt in view of healthy debt-equity ratio of 0.8 per cent, he said.

According to the GPL Vice President (Exports), Mr Srinivas Sadu, the company expects an exponential growth in exports over the next few years by aggressively tapping the regulated markets through a combination of direct sales and contract manufacturing. As against the current exports level of $5 million to the unregulated markets, the company was confident of raising exports to the level of $100 million by 2007 in view of the premium price advantage in the regulated markets, he said.

Of the Rs 9.68-crore current equity base of the company, the German collaborator, Vetter Group, holds 16 per cent, the German Bank holds 12 per cent, ICICI Venture Capital and APIDC Venture Capital together hold 12 per cent, while the Indian promoters, led by Mr P.V.N. Raju, hold the balance 60 per cent. The company has a reserve base of over Rs 40 crore, Mr Rao said.

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