The last month has been a busy time for Iceland’s Actavis, a firm which only a few weeks ago had to reassure the industry that it was protected from the crisis enveloping the Icelandic financial system. Towards the end of October, the firm announced that it was formally launching its presence in the French generics market, having been preparing the ground since 2007. Just a few days later the firm announced that it was expanding its presence in India by constructing new solid oral dosage facilities at its existing site in Alathur. The firm added that three construction projects were underway in India, and reported at the same time that it had inaugurated new laboratories at Ticel Bio Park in Chennai, India. Actavis’ physical presence was also boosted on 3rd November, with the news that the firm had opened new expansions to analytical and development laboratories to expand its R&D efforts in Florida.
Actavis has also announced plans to expand through alliances. On 30th October, the firm reported that it had entered into an exclusive distribution agreement for a number of generic products with J&M Pharma, a South Korean-owned and operated pharmaceutical firm. Actavis commented that this would be an important step in its plans to build its presence in the Korean market. A few weeks later, Actavis announced that it had concluded a preliminary agreement with ASKA Pharmaceutical, through which the two firms would establish a joint company through which Actavis could enter the Japanese generic market. Clearly, with the building work in India and the agreements in Korea and Japan, Actavis is looking to the Asia Pacific region to provide new sources of revenue.
Actavis has also been busy with product launches, announcing on 28th October that it had launched its atorvastatin product, Atacor, in Serbia. A few weeks later, on 13th November, the firm announced that it had launched its azithromycin product and Chlamydia testing kit in the United Kingdom.
However, for all these steps forward, Actavis has also found itself taking a step back. On 14th November, the US Department of Justice announced that the US was seeking a permanent injunction to bar Actavis Totowa and Actavis, as well as two of their leading officers, from the manufacture and distribution of generics until Actavis Totowa, the firm’s plant in New Jersey, was in compliance with Good Manufacturing Practices. Actavis Totowa, which had previously been the plant for Amide Pharmaceuticals before Actavis acquired the firm, has not had a good year, finding itself on the wrong side of a number of FDA inspections. The plant and Actavis has also found itself involved in congressional efforts to carry out an investigation into the plant, as part of oversight efforts regarding the FDA. Events came to a head after a batch of Actavis’ digoxin tablets from the plant were found to have double the stated dosage. Although Actavis has put the best spin it can on events, underlining its commitment to work with the FDA to resolve the issues and get the plant back on line, this must nonetheless be a disappointing end to an exciting few weeks for the firm.
Ian Platts - Editor, World Generic Markets
Showing posts with label US FDA. Show all posts
Showing posts with label US FDA. Show all posts
Monday, December 1, 2008
Thursday, November 20, 2008
Mixed fortunes for Caraco
Caraco Pharmaceutical Laboratories has found itself with mixed fortunes in recent weeks. According to an article in the Detroit News (see page 4), the firm has plans to boost production at its New Centre manufacturing plant next year with a US$22 million expansion that will see it take on another 600 members of staff, doubling the size of the firm. This is undoubtedly good news both for Caraco and for the Detroit area, and appears to show that this firm at least is confident that it can buck the trend of the looming recession currently threatening the United States and much of the world. The Detroit News’ article came just over a year after Michigan’s governor announced that Caraco was to invest some US$14.5 million in a 140,000 square foot expansion of its manufacturing facilities in Detroit, and these two events show Caraco to be in good health.
That impression was backed up in late October 2008, when Caraco reported its second quarter and six month results for its fiscal 2009 (see page 5). Caraco’s net sales jumped by nearly 200% for the latest second quarter compared to the previous one, and net sale jumped by just over 200% for the first half of the current fiscal year compared to fiscal 2008. Caraco’s second quarter fiscal 2009 results were nearly 18% higher than its first quarter results, which in turn were over 200% higher than the first quarter fiscal 2008 sales. For both its first and second quarter results, Caraco has said that its sales results have been largely down to sales of distributed products under its distribution and sales agreement with Sun Pharma. Clearly, Caraco is enjoying a period of excellent growth.
However, on 3rd November 2008, the company reported a potential spanner in the works. The FDA issued Caraco with a warning letter issued as a follow-up to the last FDA inspection of the Detroit facility in May 2008. At the time, Caraco responded to all of the observations made within 30 days and took corrective action. However, the new warning letter suggests that there were inadequate and untimely investigations by Caraco’s quality control unit; Caraco noted that the FDA considered some of its observations to be repeat observations. Caraco has naturally stressed that it will work to resolve the issues, but at the same time the firm has noted that the FDA could act by withholding approval of pending new drug applications listing the facility as the manufacturer. Were this to happen, it could upset Caraco’s future plans for the Detroit plant.
Ian Platts - Editor, World Generic Markets
That impression was backed up in late October 2008, when Caraco reported its second quarter and six month results for its fiscal 2009 (see page 5). Caraco’s net sales jumped by nearly 200% for the latest second quarter compared to the previous one, and net sale jumped by just over 200% for the first half of the current fiscal year compared to fiscal 2008. Caraco’s second quarter fiscal 2009 results were nearly 18% higher than its first quarter results, which in turn were over 200% higher than the first quarter fiscal 2008 sales. For both its first and second quarter results, Caraco has said that its sales results have been largely down to sales of distributed products under its distribution and sales agreement with Sun Pharma. Clearly, Caraco is enjoying a period of excellent growth.
However, on 3rd November 2008, the company reported a potential spanner in the works. The FDA issued Caraco with a warning letter issued as a follow-up to the last FDA inspection of the Detroit facility in May 2008. At the time, Caraco responded to all of the observations made within 30 days and took corrective action. However, the new warning letter suggests that there were inadequate and untimely investigations by Caraco’s quality control unit; Caraco noted that the FDA considered some of its observations to be repeat observations. Caraco has naturally stressed that it will work to resolve the issues, but at the same time the firm has noted that the FDA could act by withholding approval of pending new drug applications listing the facility as the manufacturer. Were this to happen, it could upset Caraco’s future plans for the Detroit plant.
Ian Platts - Editor, World Generic Markets
Thursday, September 25, 2008
US FDA issues import alert for key Ranbaxy products
The US FDA has issued two warning letters to Ranbaxy Laboratories and an import alert for generic drugs produced by the company's Dewas and Paonta Sahib plants in India. The warning letters identify the Agency's concerns about deviations from US cGMP requirements, while the import alert covers more than 30 different generic drug products produced in multiple dosage forms at these two locations.
While the FDA noted that it was confident that other manufacturers could meet market demands, and no product recall had been issued, the Wall Street Journal has reported that some drug stores are looking for alternative suppliers and were nervous that if they did switch they would be liable for cost increases due to contract provisions. Meanwhile, other countries have started to look at bans. In New Zealand, for example, the Health Ministry's drug regulatory arm has said that it was checking with regulators abroad to see if audits since then had given it a clean bill of health, though like the FDA it noted that there were no concerns about the medicines themselves and that users should continue taking the drugs.
This is not the first time that Ranbaxy has been in hot water with US regulators, and represents the second time in less than three years FDA has issued a Warning Letter to Ranbaxy. In 2006, FDA cited the Indian firm for violations of US cGMP at its Paonta Sahib facility. Since then, Ranbaxy has been attempting to resolve the issue with US regulators. However, in 2007, US officials seized documents from Ranbaxy's US headquarters in New Jersey. Furthermore, in July 2008, the US Department of Justice claimed that the company submitted false information about stability and bioequivalence to support ANDAs for antiretrovirals distributed by the President’s Emergency Plan for AIDS Relief (PEPFAR) programme. Prominent Congressmen on the US House Committee on Energy and Commerce indicated at the time that they would commence a formal investigation into the Ranbaxy drug approvals and potential violations of GMP regulations.
Daiichi Sankyo, which agreed to acquire the majority of the voting capital of Ranbaxy in June, has yet to comment on the latest events, though both firms have previously stressed that the share purchase agreement is binding and final. North America is a significant market for Ranbaxy, however; the region constituted around 26% of the firm’s revenues in 2007. Ranbaxy is already looking aggressive in its attempts to overturn the FDA’s ruling, enlisting former New York mayor Rudy Giuliani to represent it in Court in an attention-grabbing move. Nevertheless, the firm may need more than PR to help it out of its current predicament.
Jonathan Way - Editor, World Generic Markets
While the FDA noted that it was confident that other manufacturers could meet market demands, and no product recall had been issued, the Wall Street Journal has reported that some drug stores are looking for alternative suppliers and were nervous that if they did switch they would be liable for cost increases due to contract provisions. Meanwhile, other countries have started to look at bans. In New Zealand, for example, the Health Ministry's drug regulatory arm has said that it was checking with regulators abroad to see if audits since then had given it a clean bill of health, though like the FDA it noted that there were no concerns about the medicines themselves and that users should continue taking the drugs.
This is not the first time that Ranbaxy has been in hot water with US regulators, and represents the second time in less than three years FDA has issued a Warning Letter to Ranbaxy. In 2006, FDA cited the Indian firm for violations of US cGMP at its Paonta Sahib facility. Since then, Ranbaxy has been attempting to resolve the issue with US regulators. However, in 2007, US officials seized documents from Ranbaxy's US headquarters in New Jersey. Furthermore, in July 2008, the US Department of Justice claimed that the company submitted false information about stability and bioequivalence to support ANDAs for antiretrovirals distributed by the President’s Emergency Plan for AIDS Relief (PEPFAR) programme. Prominent Congressmen on the US House Committee on Energy and Commerce indicated at the time that they would commence a formal investigation into the Ranbaxy drug approvals and potential violations of GMP regulations.
Daiichi Sankyo, which agreed to acquire the majority of the voting capital of Ranbaxy in June, has yet to comment on the latest events, though both firms have previously stressed that the share purchase agreement is binding and final. North America is a significant market for Ranbaxy, however; the region constituted around 26% of the firm’s revenues in 2007. Ranbaxy is already looking aggressive in its attempts to overturn the FDA’s ruling, enlisting former New York mayor Rudy Giuliani to represent it in Court in an attention-grabbing move. Nevertheless, the firm may need more than PR to help it out of its current predicament.
Jonathan Way - Editor, World Generic Markets
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