Hi-Tech Pharmacal: A Solid Source of Quality

Generic SupplementsGeneric Supplement 2011

In a highly competitive industry that faces continued challenges, Hi-Tech Pharmacal remains the rock-solid source of quality products it has been for the last 3 decades.

An established US-based company that prides itself on being customer-focused, Hi-Tech Pharmacal reported record sales for the year ending April 30, 2011. David Seltzer, President and CEO, commented, “We are very pleased with results for fiscal year end as we reported the best results in the Company’s history. Our generic version of Flonase®, in particular, was an outstanding success, and we continue to gain market share. Our pipeline of products has never been stronger.”

Hi-Tech has the expertise necessary to develop and manufacture liquid and semi-solid dosage forms—such as Fluticasone Propionate, generic for Flonase®—including products that require sterile manufacturing.

Currently, 13 Hi-Tech products have been submitted to the FDA pending approval, and approximately 20 products are in various stages of development. The company is continually expanding its range of products, dosage forms, and packaging configurations.

Hi-Tech recently acquired the marketing and distribution rights to several unique branded products for the treatment of pain from Atley Pharmaceuticals. The products will be distributed through ECR Pharmaceuticals, a subsidiary of Hi-Tech Pharmacal. ECR’s line already includes branded prescription products for the treatment of allergies, headaches, and dermatitis/poison ivy.

Thus far in calendar year 2011, Hi-Tech has received final approval for Levofloxacin Ophthalmic Solution, Gabapentin Oral Solution (under 180-day exclusivity), Lidocaine Jelly 2%, Ranitidine Syrup, and Levofloxacin Oral Solution (also under 180-day exclusivity). Levofloxacin Oral Solution is the generic for Levaquin® Oral Solution, which generated annual sales of approximately $6 million.

The FDA has granted Hi-Tech tentative approval for the generic for Allergan’s Combigan® ophthalmic solution, which had sales of $108 million in 2010. Hi-Tech plans to launch the product after the company receives final approval from the FDA.

With more than 20 projects currently in development, Hi-Tech maintains an ongoing commitment to an ambitious R&D program. Hi-Tech is currently developing drugs with total branded sales of over $4 billion, including sterile ophthalmic products, oral solutions and suspensions, and solid dosage forms, which will bring a broad range of opportunities to its pharmacy partners over the next several years.

“We’re committed to finding ways to deliver value at Hi-Tech,” notes Seltzer. “We’re driven by the same core values we established when the company was founded in 1981—focus, innovation, confidence, and trust.” Seltzer exhibits the confidence that comes with success. “We remain very optimistic about our future,” he says. “We see tremendous opportunity ahead of us as our generics pipeline is more robust than ever.”

For his part, Hi-Tech Vice President of Sales and Marketing, Ed Berrios, points out that “Expanding our portfolio of key and niche products adds another level of value for our customers.”

“Every new product is another opportunity to make strong partnerships even stronger,” Berrios says. “Our pharmacy partners are an integral part of our success, and we’re committed to providing even greater value in the future. That’s why we continue to invest in Research and Development— more than doubling our spending on R&D over the last 5 years.” PT

For more information, visit www.hitechpharm.com.

Levofloxacin Oral Solution 25 mg/mL is now available in multiple sizes—480 mL, 200 mL, and 100 mL.

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