The capsules are in strengths of 5 mg and 10 mg and are used in treating insomnia, the filing added.

With this approval, the total ANDA approval count of Orchid has gone up to 37 while the total ANDA filings stand at 58, it added.

Earlier, on September 16, the pharma firm had received the US drug regulator's nod for its Piperacillin and Tazobactam injection used to treat infections caused by certain bacteria and accordingly had been granted 180-days generic drug exclusivity.

"The US Food and Drug Administration has also determined that Orchid is first applicant for the product and has "accordingly granted 180-days generic drug exclusivity, under applicable provisions," Orchid Chemicals said in a filing to the Bombay Stock Exchange.

The company gets USFDA approval for its Abbreviated New Drug Application, the filing added.

These approvals cover Orchid's generic equivalent in 2.25 g and 3.375 g and 4.5 g vial as well as 40.5 g dosage forms and strengths, it said.

"We are not only the first generic product to be approved but also have been granted 180-days generic drug exclusivity," Orchid Chemicals & Pharmaceuticals Managing Director Raghavendra Rao said.

The company would be launching this product in marketing and distribution partnership with Apotex in the US, the filing said.

Shares of Orchid Chemicals & Pharmaceuticals were trading at Rs 138.10 on the BSE, up 9.13 per cent from previous close. 

The litigation was relating to Desloratadine Tablets, 5 mg and Desloratadine 2.5 mg and 5 mg Orally Disintegrating Tablets (ODT), the generic versions of Schering-Plough's Clarinex and Clarinex RediTabs allergy medication. The agreement marks the end of all pending lawsuits filed and consolidated since 2006 in the US District Court of New Jersey.

Under the settlement, Orchid will have the right to market Desloratadine Tablets, 5 mg and Desloratadine 2.5 mg and 5 mg Orally Disintegrating Tablets in the US on July 01, 2012 and January 01, 2012 respectively, according to Orchid’s release. the agreement is subject to review by the Department of Justice and the Federal Trade Commission, the release added.

According to reports, total US sales for Clarinex products were $295 million (around Rs 1,475 crore) in 2008.

The company has received final US Food and Drug Administration (USFDA) approval, Orchid Chemicals said in a filing to the Bombay Stock Exchange (BSE).

The approval of Sumatriptan Succinate tablets are in the strengths of 25 mg, 50 mg and 100 mg.

The company has received approval from the US Food and Drug Administration (FDA) for its anti-hypertensive tablets Amlodipine Besylate, the Chennai-based pharmaceuticals firm said in a filing to the Bombay Stock Exchange.

The approval has come for 2.5 mg, 5 mg and 10 mg tablets, the company said.

With this nod, "Orchid's cumulative Abbreviated New Drug Application (ANDA) approval count stands at 32 and the total ANDA filing count stands at 50," the company added.

Shares of Orchid Chemicals were trading at Rs 96.50, up 0.89 per cent in the late afternoon trade on the BSE.

The company had recently redeemed $40.05 million worth face value of FCCBs, which were available at over 50 per cent discount to the earlier agreed price. In the process, it has reduced its outstanding FCCBs to $154 million from $194 million.

Orchid had earlier gone in for two FCCB issues of $19 million, coming up for redemption in October 2010, and $175 million due in February 2012. Both were ‘zero’ coupon bonds with a yield-to-maturity rate of 7.87 per cent and 7.25 per cent respectively.

“We felt it expedient to go in for ECBs from banks to buyback these FCCBs, which were available at a significant discount. The window is available until the end of this year to effect further buyback if there is an opportunity,” K Raghavendra Rao, promoter and managing director, Orchid Chemicals & Pharmaceuticals, told Financial Chronicle.

The move has helped the Rs 1,300-crore company to bring down its debt to equity ratio to a reasonably comfortable 1:2, from a staggering 1:3 prior to the buyback. While the company’s capital, including equity, is around Rs 688 crore, the total debt, including FCCBs, hovered around Rs 1,900 crore. Going forward, the company aims to bring it further down to 1:1.5 or even 1:1.

“The ECB route option has given us a longer tenure for repayment as against the residual part of the FCCBs. It has brought in more stability as these FCCBs were available at a significant discount and also helped reduce the uncertainty on FCCBs, especially in terms of conversion,” Rao said.

He agreed that given the present capital market scenario, not many FCCB holders would opt for conversion into equity. “In that case, we would have found ourselves in a corner, with the need to make a one-time bullet payment of $280 million sometime in February 2012, assuming all FCCBs come up for redemption coupled with the yield-to-maturity payments,” Rao explained.

He is happy that lower stock prices and market scenario would deter FCCB holders from opting for equity conversion, which otherwise may result in further dilution of the promoters’ stake. In fact, just about a year ago, he was rattled by a takeover bid by Ranbaxy.

Orchid had focused its attention on five verticals – cephalosphorins, penicillin injectibles, carbapenems, non-antibiotics Para IV, which the company was the first to file, and research and development (R&D).
While it was generating revenues only from cephalosphorins, it had to direct funds across all focussed verticals to support the development stage demands.

“So far, it was only cephalosphoporin that was generating revenue for us. Now, penicillin, which we have recently launched in Europe and will shortly be taking to the US, has joined the fray. This vertical will come into full revenue play by the end of this quarter,” K Raghavendra Rao, managing director, Orchid Chemicals, told Financial Chronicle.

Even as Carbapenems will join the revenue-play by early 2010-11, it will be the turn of non-antibiotics to start generating revenues in 2011-12. “We are now on the cusp of our second wave of growth and are confident of achieving substantial growth of at least 20 per cent year-on-year over the next three years,” Rao said.
While more verticals are set to attain revenue-generating status from now on, the company has also re-addressed its focus on R&D, ever since Dr Gopalan, a former chief scientific officer (CSO) with Glenmark, joined Orchid Research Laboratories in the same capacity sometime ago. “His joining helped us to focus on action-based development and set up a superlative team to offer a 360-degree support to the researches undertaken,” Rao said.

The team chose four therapeutic areas – diabetes, pain management, oncology and anti-infection, instead of a wider canvas that it had focused for research in the past.
“We are methodical in doing it now, than in the past. Compared to the last three years, the next three years are going to see significant growth, as we feel more variable factors are now under our control,” he pointed out.

Orchid registered a turnover of around Rs 1,300 crore and a profit after tax of Rs 175 crore, which included a Rs 71 crore of FCCB-related forex gain in financial year 2007-08. For the nine-month period of financial year 2008-09, the company, on a consolidated basis, reported a topline of Rs 1,035 crore and a loss of Rs 76.48 crore, which included a FCCB forex related loss of Rs 171 crore.

Currently, 85-90% of the company's turnover of Rs 1,300 crore comes from cephalosporins, said CH Ram, head (communications and investor relations).

"But in financial year 2009-10, turnover from cephalosporins would reduce and that from penicillin injections, primarily Tazo-Pip, would be about 10-15%," he said.

Similarly, carbapenems would contribute 10-15% to Orchid's turnover by fiscal 2010-11. "Gradually, our dependence on cephalosporins would come down, and that on carbapenems and penicillin injections would increase," Ram added. Orchid launched Tazo-Pip in the EU a week and a half ago and will soon launch it in US. The company will focus more on regulated markets such as the EU, the US and Japan than on emerging markets.

Orchid will be the first Indian company to raise funds through external commercial borrowings to substantially bring down its debt. The move takes advantage of recently liberalised norms that permit companies to use proceeds from overseas debt to retire FCCBs.

The finance ministry’s changes came after several companies told the government it was proving difficult to raise debt at competitive rates from within the country to service convertible debentures. The alternative was to allow conversion of the paper into equity on maturity, which would reduce the price of shares and hurt existing holders.

Orchid MD K Raghavendra Rao told FE, “We felt it is the right time to buy back the FCCBs as they are currently traded at a substantial discount. We cannot say exactly what price the company will buy them back, but it will be at a good discount. The move will help bring down our total liabilities, apart from help improve the balance sheet leverage significantly in quarters to come.”

Orchid’s FCCBs are being traded at a significant discount. The paper will mature in February 2012 at a strike price of Rs 348 for conversion to equity. Their current yield to maturity is 7.25%.

The company, which was being stalked for takeover by Ranbaxy in 2008, now expects to appoint an investment banker to conduct the overseas debt issue before March 2009. A senior company official said the discounted price of the FCCBs makes it easy to retire them: “We see this is a positive move that will help reduce our debt burden sharply.”

The company has a total debt of Rs 2,000 crore, including FCCBs. The company’s third-quarter operating income stood at Rs 310.21 crore, with a net loss of Rs 6.31 crore. Its new Piperacillin-Tazobactum drug is hoped will add close to Rs 360 crore to its top line.