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US FDA approval for Orchid's ceftriaxone vials



4 August, 2005: Orchid Chemicals & Pharmaceuticals Ltd has received the formal approval from the US FDA for its generic ceftriaxone ANDA. The marketing approval has been granted for ceftriaxone for injection, 250mg, 500mg, 1gm and 2gm single-dose vials, 1gm and 2gm piggyback vials and 10gm/100 ml pharmacy bulk package vials. 

The Chennai (India)-based Orchid will distribute its ceftriaxone generic formulations in the US exclusively through Apotex Corp. The company has already shipped the product to the US in sufficient quantities based on prior FDA clearance. Apotex will start distribution of the products to its customers from the day of approval, said an Orchid release. 

Ceftriaxone is an injectable third generation cephalosporin antibiotic that went off-patent recently. The estimated annual retail sales of this product was around USD 700 million prior to patent expiry. 

The company has received the USFDA approval for its Ceftriaxone generic within 13 months of its ANDA submission. This is the third cephalosporin ANDA approval the company has received in recent months. The company expects more ANDA approvals to follow in the months to come. As of date, the company has filed 19 ANDAs with the US FDA. 

Orchid Chemicals & Pharmaceuticals Ltd has diversified competencies in bulk drugs, formulations and drug discovery. The company has achieved a turnover and operating income of Rs 170.26 crore for the quarter ended June 30, 2005 (Q1 FY 05-06) in comparison to Rs 173.86 crore registered during the corresponding first quarter of last fiscal. Gross profit before interest, depreciation and extraordinary items was Rs 45.86 crore compared to Rs 37.24 crore during the corresponding quarter of last year. Profit before tax was Rs 8.19 crore as against Rs 5.09 crore of the Q1 of last fiscal, despite higher outgo on depreciation (Rs 16.91 crore as against Rs 15.29 crore) and interest (Rs 20.76 crore as against Rs 16.86 crore). Net profit after tax registered a robust growth of 56% and stood at Rs 7.33 crore compared to Rs 4.69 crore of Q1 last fiscal.

Orchid’s US generics business is poised to take off from the second quarter with the introduction in the market of products which have received the USFDA approval. The company received two ANDA approvals from the USFDA, for cefazolin injections and cephalexin capsules during the quarter. Besides ceftriaxone injections, this fiscal expects the launch of cefprozil tablets, that is going off-patent.

The cumulative count of DMFs and ANDAs at the end of the quarter stood at 18 and 19 respectively. More filings are planned in the balance quarters of this fiscal to nearly double the regulatory filings count, a company statement said.


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