Coveted pills popping out of city

JMI Daniels Pharmaceuticals, at 2517 25th Ave. N, produces a popular thyroid drug.

By SHARON BOND

© St. Petersburg Times, published June 18, 2000

ST. PETERSBURG -- JMI Daniels Pharmaceuticals is one of the city's lesser-known businesses with a national, even international, presence. It produces 20-million tablets of the thyroid drug Levoxyl a week in a small complex tucked away in an industrial part of central St. Petersburg.

An $8-million expansion has made the complex at 2517 25th Ave. N more visible. But JMI Daniels remains a cloistered operation. Exactly how the drug is made -- gleaming stainless steel machines move batches of raw powder to the new rotary press that stamps out 700,000 pills an hour -- is proprietary.

"We're in a very competitive area," said Rocco L. Gemma, vice president of operations, referring to the Levoxyl market.

That is particularly true now. JMI Daniels is going through a Federal Drug Administration-mandated application renewal process to continue making Levoxyl. The drug aids people with underactive thyroid glands by adding a synthetic version of the hormone the thyroid produces. All manufacturers of Levoxyl are required to go through this process.

Gemma said JMI Daniels controls about 22 percent of the $300-million annual Levoxyl market. It is one of two brands of Levoxyl. Other companies make generic versions of the levothyroxine sodium tablets.

"The expansion was required because we wanted to reach the manufacturing standards of the FDA," said Elaine Strauss, vice president of quality assurance and quality control.

"The FDA requirement is to assure that a patient would receive the same level of product each time he took it," Strauss said. Once patients begin Levoxyl, they must take it for the rest of their lives, she said.

Jones Pharma Inc., headquartered in St. Louis, is the parent company of JMI Daniels. Jones Pharma's business is buying lesser-known, FDA-approved products from large corporations and then vigorously marketing them to increase sales.

The St. Petersburg plant is the company's sole producer of Levoxyl, and it does manufacturing and packaging only. Sales and distribution are handled from St. Louis. Gemma said there is a market for as much Levoxyl as the plant can make.

Levoxyl tablets are bottled in a fully automated production line. A computer fills plastic bottles with the correct number of pills at the proper tablet strength. The drug is manufactured in 12 strengths. The bottles move along the conveyor to receive a cotton ball, airtight seal, cap and bar code. At the end of the line, production information is glued to the cap.

The bottles are then inspected and packed in boxes by hand.

Throughout the production and packaging process, Levoxyl is tested to ensure quality. During the FDA application process, the plant's laboratory has numerous experiments going. They determine, for example, how long Levoxyl will last in extreme heat or cold or how long it takes to dissolve after ingestion.

Gemma said the St. Petersburg plant was built in 1977 as part of Daniels Pharmaceuticals. Jones Medical Inc. acquired Daniels in 1996. Last year the name of the parent company was changed to Jones Pharma Inc. The St. Petersburg plant carries the Daniels name also.

Levoxyl was manufactured in a collection of buildings until the recent makeover. The manufacturing operations were enlarged, new equipment installed and the separate buildings joined by a corridor built across the front. A new facade and landscaping were added, and the plant now is a better looking member of the Ponce de Leon neighborhood. It is near the new Lowe's Home Improvement store off 22nd Avenue N.

The remade facility also is more convenient and comfortable for its 120 employees. More important, it provides a climate-controlled environment that is much easier to maintain.

© St. Petersburg Times. All rights reserved.