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Pharma/fine chemicals roundup—1 July 2014

7:32 AM MDT | July 1, 2014 | By DEEPTI RAMESH

Feature
FDA tightens control over India’s API manufacturers

FDA has, since 2013, issued warning letters to several active pharmaceutical ingredient (API) manufacturing facilities in India. According to figures from the FDA Web site, warning letters were issued in 2011 to three API manufacturing facilities in India, but no such warnings were issued in 2012. Experts say the recent rise in letters to India is linked to a stronger FDA presence there and inspections at short notice. “The FDA has now set up a strong base in India with a group of inspectors permanently based in the country. And, the FDA is now inspecting plants at short notice, contrary to the past, when inspections were announced several weeks or even months in advance, allowing companies to prepare,” says Enrico Polastro, v.p. and senior industry specialist at Arthur D. Little (Brussels). “Now that these inspections are being done at short notice, the real problems at these facilities are emerging,” Polastro says. When contacted by CW, certain companies that have received warning letters declined to comment on the reasons for the warnings and on progress they have made in resolving the issues.

Umicore appoints Sangjin as exclusive sales agent for its APIs in South Korea

Umicore (Brussels) says that it has appointed Sangjin Co. as the exclusive sales agent for Umicore’s active pharmaceutical ingredients (APIs) in South Korea. “We are delighted with the appointment of Sangjin, a leading distributor in South Korea, as our agent in this important market,” says Alexander Wörner, head of sales/global API business at Umicore. “With their widely-recognized reputation and a clear focus on customer needs, we feel that Sangjin is an ideal partner to represent Umicore. Sangjin will enable us to move even closer to our customers, which is a key element of Umicore’s business philosophy.”
Umicore operates an API plant in Pilar, Argentina. Opened in 2009, the facility manufactures platinum APIs used in chemotherapy. The company is currently experiencing rapid growth of these activities and continues to expand its global presence in line with recent regulatory achievements, Umicore says.

Aesica’s expansion at Queenborough, UK site creates 40 new jobs

Aesica Pharmaceuticals (Newcastle, UK) has announced 40 new job openings at its Queenborough, UK site. The recent expansion at the Queenborough site has resulted in these new job openings. Aesica, in March 2014, announced that its previously announced new $45-million high capacity manufacturing facility has been validated for commercial production. With the completion of this new facility, Aesica has expanded the commercial production of a solid dose medication used in treating Type 2 diabetes in adults.

Shire rejects AbbVie's unchanged proposal

Shire (Dublin), on 25 June, announced that its board of directors has unanimously rejected the unchanged proposal from AbbVie (Chicago) to acquire Shire, for £20.44 ($35) in cash and 0.7988 AbbVie shares per Shire share. Shire says that its board has rejected the proposal as it fundamentally undervalues Shire and its prospects. The proposal values Shire at over £27 billion. AbbVie first made a proposal on 30 May. AbbVie is a research-based pharmaceutical company formed in 2013 following separation from Abbott Laboratories (Chicago). Shire’s product sales have increased from $2.75 billion in 2008 to $4.75 billion in 2013, representing a five-year compound annual growth rate (CAGR) of 11.6%, Shire says. Shire’s non GAAP diluted earnings per share have increased from $3.86 in 2008 to $7.66 in 2013, representing a five-year CAGR of 14.7%, Shire says.

Beyond IHS Chemical Week:

Indian government mulls API policy
from the Business Standard, India

The Indian government intends to revive the country's active pharmaceutical ingredient (API) or bulk drug market by formulating a separate policy, which will promote the industry internationally, apart from catering to domestic requirement. The Department of Pharmaceuticals (DoP) will soon hold discussions with various stakeholders to prepare a White Paper for the policy, a senior government official said. "Formulating the draft API policy is a priority for DoP and the work in that direction has already started," the official told Business Standard, indicating the first draft of the policy may be part of the new government's 100-day agenda.

Green chemistry: Pharmaceutical companies try to clean up their act
from the Financial Times, UK

Pharmaceutical companies tend to highlight their role in saving lives, but say little about the impact their manufacturing processes might have on public health and the environment. Addressing that issue is at the heart of Phil Dahlin’s role as director of sustainability for Janssen, the pharmaceuticals arm of Johnson & Johnson, the US consumer goods group. He is leading the company’s push to meet a range of targets to cut resource consumption and waste production. This may sound like a distraction for an industry battling to come up with products to replace the many “blockbuster” drugs that have lost patent protection in recent years. However, Mr Dahlin insists his job is supporting the push for fresh growth: “You can call it green chemistry or lean chemistry. Ultimately, it’s good chemistry.”
He cites the example of a cancer drug that was broken down by Janssen scientists to explore ways of making the synthesis process more efficient. They discovered it was possible to reduce raw material input by nearly two-thirds, water usage by more than three-quarters and hazardous waste by 87%.













 
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