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Archive for November, 2008

Caraco’s Detroit plant gets quality warning

Tuesday, November 4th, 2008

read a 483 letter sometime…they are very informative…

Caraco Pharmaceutical Laboratories, in which India’s Sun Pharmaceuticals holds a 76 per cent stake, has joined the list of generics manufacturers issued with an FDA warning on quality control issues.

The warning letter, which was sent on October 31, blocks the approval of any pending abbreviated new drug applications (ANDAs) submitted by Caraco. The document relates to a US Food and Drug Administration (FDA) inspection of the firm’s facility in Detroit in May.

The following month, the FDA issued Caraco with a Form 483 detailing a list of quality observations that it needed to address. While the firm said that it had moved to correct all the shortcomings within 15 days, the FDA’s latest warning lists several “repeat observations” suggesting that Caraco still has work to do.

Although the October 31 letter has not been published in full, Caraco’s November 3 Form 8-K filing with the Securities and Exchange Commission (SEC) listed “the inadequate and untimely investigation by our quality control unit of certain incidents” among the problems that the agency considers are unresolved.

Earlier this year Caraco faced its first manufacturing setback when it was forced to withdraw several batches of its version of the generic diabetes drug metformin after it emerged that some of the tablets did not meet with approved specifications.

In an interview with India’s Business Standard, a Sun Pharmaceuticals spokesperson claimed that the FDA’s latest warning would not have a major impact on its US revenues, explaining that only 19 of its 96 pending ANDAs had been filed by Caraco.

However, given the difficulties already encountered, coupled with the fact that US generic sales represent about 40 per cent of its annual turnover, Sun is likely to seek a quick resolution in an effort to maintain Caraco’s position in the country’s booming non-branded drug market.

Caraco’s share price fell 68 cents, or 6.7 per cent, to $9.49 in morning trading on the New York Stock Exchange on the day of the announcement.

link to full article

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FDA awards contract for QbD research

Monday, November 3rd, 2008

The FDA has awarded a $1.19m contract for the development of quality by design (QbD) guidance for pharmaceutical manufacturers.

Under the contract the National Institute for Pharmaceutical Technology and Education (NIPTE) will develop design specifications.

NIPTE is a nonprofit consortium of 11 pharmaceutical engineering universities, including Purdue that will receive $300,000 to utilise its expertise in pharmacy, engineering and biological sciences to develop guidance.

Alan Rebar, senior associate vice president for research at Purdue, said: “With this FDA funding, Purdue will collaborate with other strong universities to develop this emerging area where we can focus on improving the science of drug development itself.

“This team also will study how to make the drug-manufacturing process more modern, helping improve efficiencies and the effectiveness of the pharmaceutical industry.”

Research by the consortium will start this year and is predicted to finish in September 2010, after which the information gained will be made public.

By the end of the contract the US Food and Drug Administration (FDA) is hoping to have furthered development its QbD initiative, which aims to take a more scientific approach to pharmaceutical development and manufacture.

link to full article

Posted in Uncategorized | No Comments »

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