In 1998, Able Laboratories’ revenues totaled $300,000 they’re now…

Question Answered step-by-step In 1998, Able Laboratories’ revenues totaled $300,000 they’re now… In 1998, Able Laboratories’ revenues totaled $300,000— they’re now in the tens of millions. Hem Pandya told Ruari McCallion how the company got from there to here. It takes a whole lot of money, time, and effort on detailed chemical and biological processes to discover and develop the next generation of drugs and therapies. It’s expected of the big household names, but it’s something of a surprise to find that manufacturers of generic products, the therapies that have come out of a patent, invest a high proportion on R&D as well. “We are spending about 15% of our revenue on R&D,” said Hem Pandya, VP of corporate development and commercial operations for Able Laboratories. “It’s more about development than research. We have to go through exactly the same processes as the big pharmaceutical companies to ensure that our product is bio-equivalent. Everything still has to go through human studies, although we don’t undertake the full clinical trials.” The qualification and certification process is monitored by the FDA, to exactly the same standards as are applied across the whole industry. Based in South Plainfield, New Jersey, Able Laboratories currently has 11 ANDAs (abbreviated new drug applications) pending with the FDA across a range of therapies. Since 2001, Able has received 22 FDA approvals. The company is focused on the area of ‘controlled drugs,’ therapies like Methylphenidate HCI (Ritalin) and Hydrocodone Bitartrate compounds, which were originally marketed as Lortab and Vicodin. Its state-of-the-art research and development team focuses on further developing generic drugs that already have large, established markets; developing specialty drugs that have little competition; and on products that require a high level of industry expertise to develop. “We don’t focus on one category, but we do have quite a number of pain management Adjust font size: Related Content A well-built place in th sun DiVosta Homes builds homes in Florida with a more… Always scanning for improvements Accu-Sort Systems has undergone a complete. more… Mineral wealth Searles Valley Minerals mines riches in the des more… Pushing the envelope EU Services’ Tom Loud tells Jenn Monroe how more… Quality and qualificat Business is booming fo pharmaceutical… more… Able Laboratories – The Manufacturer.com – Promoting best practice in Manufacturing Page 1 of 3 http://www.themanufacturer.com/us/profile/954/Able_Laboratories?PHPSESSID=c88bc 8/24/2007 products. Quite a number of products in the pain management sector are scheduled by the DEA. Not many companies are equipped to handle licenses,” Pandya said. Not until the late 1990s did Able Laboratories hit its true stride in the manufacture of generic drugs. Prior to that, Able had a promising lead for a new drug, but it didn’t make it past the testing phases. “Dynagen was a biotech company that bought Able Labs in the mid-1990s, primarily to manufacture a new lead compound product it had been developing.” The product was completely new and entirely its own work. “Unfortunately, that product failed phase three of clinical trials, so it never came to market,” he explained. “We had a couple of products that we were still commercially producing from 1996 to 1999, but we weren’t really focused on sales; our revenues were in the region of $300,000.” With the product that was going to be the company’s future having fallen short, it had to change direction very quickly. Fortunately, it had the facilities, processes, and skilled personnel in place. “The business really got started when it moved into the generic business in 1999,” he said. The change in direction has returned quite a staggering success. “In 2001, our revenues totaled $18 million; our third quarter 2002 figures put us on a running annual rate of $60 million,” Pandya said. Able Labs recently doubled its manufacturing capacity, and it is currently running two shifts a day. The company is undertaking some contract work for other manufacturers, but the core of its almost unbelievable turnaround is the products and compounds it has chosen to specialize in. “We identified the market for products that were smaller in brand sales, although their volumes and sales were still going up,” said Pandya. “In some cases, [they were] older lines that larger companies had dropped out of to focus elsewhere. There’s limited competition and not so much price pressure.” An example of this is the hydrocortisone acetate suppository, which has long been known as Anusol; only five companies in the US manufacture suppositories for the treatment of hemorrhoids. Able also manufactures products for tension headaches, anxiety disorder, pain relief, anti-angina, urinary tract pain, obesity, and attention deficit disorder. “There’s nothing uniquely different about our manufacturing processes, but we are focused on niche markets. All our products are prescription,” Pandya said. Competition is primarily on price, so Able concentrates on manufacturing efficiently. “We control our overhead and manage our costs closely. We’ve been able to recruit good scientists from outside the US, primarily from India. We’re running a very tight ship and not overspending on anything,” Pandya said. Able has long-term raw material arrangements, based on its need for the highest quality and most reasonably priced materials. “Apap (acetaminophen) is something we use a lot; it’s quite cheap, so we hold a lot in stock. We don’t keep so much of more expensive products,” he said.   With regard to the 2003 Article “Able Laboratories, Developing a Solution”:1. The article states Able’s focus was on “controlled drugs”. Name the two government agencies specifically charged with regulating controlled drugs. In addition, detail the Title(s), Chapter(s), Subchapter(s), and Part(s) in the CFR that specifically regulate a manufacturer of controlled drugs. List all of the related numbers and the descriptions / titles. Science Chemistry PHEN 604 Share QuestionEmailCopy link Comments (0)