Hi-Tech Pharmacal: A Solid Source of Quality

With over 3 decades of experience serving retail and institutional pharmacy, this publicly traded (Nasdaq:HITK) American company prides itself on its longstanding commitment to exemplary service and its innovative line of prescription, OTC, and specialty products.

David Seltzer, president and CEO, commented, “We are very pleased with our performance in the first half of 2013—particularly in our ability to drive sales while still making significant increases in our commitment to important long-term strategic initiatives like research and development, manufacturing and supply-chain integration, and a continual improvement in customer service and support.” Hi-Tech has the expertise necessary to develop and manufacture liquid and semi-solid dosage forms, nasal sprays—such as Fluticasone Propionate, generic for Flonase®—and products that require sterile manufacturing.

Hi-Tech currently has 15 products submitted to the FDA pending approval, including partnered products, and approximately 20 products in various stages of development. These products represent approximately $6.3 billion in branded sales, and include dosage forms ranging from oral liquids to ophthalmics. This is consistent with the company’s mission to continually expand its range of products, dosage forms, and packaging configurations.

Additionally, Hi-Tech is now well established in the development of its Unit Dose program, with 4 offerings currently on the market, and 4 more planned for introduction in the next 9 months.

Paregoric is back and in the supply chain.

To support such an ambitious and dynamic pipeline, Hi-Tech maintains an ongoing program of growing its R&D efforts. This year alone, the company has increased its expenditures in research and development by over 50% in the fiscal year ended April 30, 2013. The company has increased spending on internal projects for the generic division, which include 5 projects that require clinical trials. Clinical trials for 2 of these projects are currently ongoing.

Successful launches have included Levofloxacin Ophthalmic Solution, Gabapentin Oral Solution (under 180-day exclusivity), Lidocaine Jelly 2%, Ranitidine Syrup, Levetiracetam Oral Concentrate, and Levofloxacin Oral Solution (also under 180-day exclusivity). Levofloxacin Oral Solution is the generic for Levaquin®.

Hi-Tech’s branded subsidiary, ECR, offers a broad range of products indicated for the treatment of allergies, headaches, and dermatitis/poison ivy. This effort is supported by a growing sales force of full-time field representatives. Current brands include DexPak®, Bupap®, Tussi-Caps®, Orbivan®, Zolpimist®, and Zolvit®.

Additionally, Hi-Tech Pharmacal offers a range of well-known OTC brands such as Zostrix® through its subsidiary HCP. HCP’s primary focus is on the fast-growing diabetes specialty market, with offerings such as Diabetic Tussin® and Diabeti-Derm®.

“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.”

Ed Berrios, Hi-Tech Vice President of Sales and Marketing, adds, “One of the most important things we can do for our customers is to continue to grow our portfolio of key and niche products. Adding new dosage forms and technical capabilities, developing new products—everything we do is about helping our customers help their patients.”

“We understand that the pharmacies aren’t just our customers, they’re our partners in business,” Berrios continues. “We make sure that their success and satisfaction is always at the top of our business goals.”

For more information, visit www.hitechpharm.com.