Ingredients

EU Risks Drug Shortages If API Import Regs Not Waived for US Says SOCMA

19-Jun-2013 - Europe could face drug shortages if the US is not granted exemption from new API import requirements, according to a US chemical industry trade association.

It Had To Be Yew? Not So Says Phyton With New Docetaxel CEP

19-Jun-2013 - Phyton Biotech has received European approval for a version the cancer drug API docetaxel whose production does not rely on the scarce yew tree extract used in traditional manufacturing methods.

UPDATE

Industrial Action Halts Operations at Indian CMO Shasun Facility

18-Jun-2013 - Shasun Pharmaceuticals’ says it is trying to restart operations at the earliest opportunity after workers went on strike at its API and formulation facility in India last Sunday.

UK Moves to Prevent API Shortages Ahead of New EU Import Laws

18-Jun-2013 - The UK MHRA plans to let drugmakers import APIs that lack ‘written confirmation’ of quality if there is an overriding need to ensure continued supply.

EC welcomes list of Indian API suppliers with ‘written confirmation’

13-Jun-2013 - The European Commission has welcomed the publication of the list of Indian API makers issued with “written confirmations” of quality by the CDSCO.

Some China API Firms Wont Have 'Written Confirmations' by July says blue inspection body

12-Jun-2013 - Some Chinese firms wont have the 'written confirmations' required to ship APIs to the EU from July according to the German audit firm tasked with helping manufacturers prepare by Beijing industry group, CCCMHPIE.

Fujifilm and Dr. Reddy's End Japanese JV, though Future Deals Likely

11-Jun-2013 - The Japanese joint venture between Dr. Reddy’s and Fujifilm has been called-off though both say future collaboration remains likely, especially in API production.

Japan Gets 'Third-Country' Status to Import APIs to the EU after Impending Deadline

10-Jun-2013 - Japan has become the third country outside the EU to be exempt from providing written confirmation that APIs imported into Europe have met required standards when legislation commences on July 2nd.

Manufacturing Restarts at Teva API Plant After Deadly Explosion

05-Jun-2013 - Limited operations have recommenced at a Teva API facility in Israel after a blast that killed one and injured over 30.

News in brief

Sun Pharma Looking to Grow but Meda Denies Takeover Discussions

05-Jun-2013 - Swedish allergy drug company Meda has denied it has been in discussions with Sun Pharma over a possible $5bn (€3.8bn) takeover.

Slow Releasing Contraceptive API Led to Janssen's Latest Recall

05-Jun-2013 - Janssen has recalled 179 batches of an oral contraceptive after problems with the release of the active pharmaceutical ingredient (API) were discovered.

USP Delays Deadline for Industry to Comply With Elemental Impurity Standards

03-Jun-2013 - USP has decided to delay the implementation of two general chapters on elemental impurities until ICH has further established its own impurity testing requirements.

3M Prepared as Final Two CFC-Based Inhalers to be Phased Out

30-May-2013 - 3M says it has cooperated with the FDA and invested in its facilities in preparation of the phase-out of CFC containing metered dose inhalers (MDIs).

Fresenius to Import TPN Drug Components from Norway to Cut US Shortage

30-May-2013 - The US FDA is allowing Fresenius Kabi USA to import trace elements and phosphate injections from its Norway plant to help improve a critical shortage of components of total parenteral nutrition (TPN).

EMA Updates Inspector Expectations for API Audits

27-May-2013 - As new API regulations are set in July for those outside the EU, the European Medicines Agency (EMA) has unveiled what its inspectors expect to see from API manufacturer or supplier audit reports from inside the region.

Pfizer Takes Issue with European Commission’s Plans to Regulate ATMPs

23-May-2013 - Pfizer and other EU industry and academic groups are calling on the European Commission to revise its plans for authorizing and regulating ATMPs (advanced therapy medical products).

Possible API Contamination at Chinese CMO Leads to Canadian Recalls

22-May-2013 - Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.

Pfizer Puts Lipitor Site Up For Sale as Patent Expiration Causes Over-Capacity

16-May-2013 - Lower sales of off-patent former blockbuster Lipitor have prompted Pfizer to try and sell off its third Irish API plant in as many years.

Coalition Calls for Science-Based Approach to Elemental Impurity Testing

15-May-2013 - Differences in elemental impurity standards being developed separately by the US Pharmacopeia and ICH could mean costly reformulations according to a pharmaceutical, API and excipient industry coalition.

Aesica Accesses Atom-Efficient Amide Tech in Academic Accord

14-May-2013 - Making amide bonds may be greener and cheaper in the future according to Aesica, which has partnered with UK scientists to commercialize a new synthesis technique.

Canada Solidifies GMP Requirements for APIs to Secure Supply Chain

14-May-2013 - Looking to align with other industrialized nations, Canada has agreed to extend its GMP requirements for all active pharmaceutical ingredients (APIs), according to a notice in the Canada Gazette .

Large Scale Manufacturing Drives AMRI Q1 Revenue Uptick

14-May-2013 - Large scale manufacturing contract revenue in the first quarter of 2013 increased 14% over the same quarter in 2012 as AMRI (Albany Medical Research Inc.) saw an 11% increase in overall revenue.

EMA Seeks to Revise Some Phthalate Limits in Excipients

08-May-2013 - The EMA may recommend new daily exposure limits for some phthalates as animal data have shown they can cause negative reproductive and development effects, according to a new draft guideline .

FDA Releases Alexion Response to Form 483 on Microbial Contaminations

07-May-2013 - In a rare move, the FDA has publically released Alexion Pharmaceuticals’ response to a Form 483 following inspection of its US site and the discovery of microbial contamination.