Indian manufacturers cut vaccine prices for GAVI

07-Jun-2011 - Indian drugmakers Serum Institute and Panacea Biotech have reduced what they charge the GAVI for vaccines, prompting similar commitments from several Big Pharma firm.

News in brief

Avacta lands top 10 US pharma buyer for Optim platform

07-Jun-2011 - Analytical technology firm Avacta says it has won its first top ten US pharma customer in collaboration with marketing partner Pall Life Sciences.

Xcellerex wins new customers for manufacturing techs

06-Jun-2011 - Biomanufacturing technology firm Xcellerex has had a good start to June with R-Pharm and Fujifilm Diosynth signing up as customers.

Pfizer considers generics manufacturing JV with Hisun

06-Jun-2011 - Pfizer says it is considering a manufacturing-focused partnership with China’s Zhejiang Hisun Pharmaceutical as part of its generic drug business.

update

Watson buys Specifar in busy month of M&As for generics sector

31-May-2011 - Watson Pharmaceuticals has bought Greek generics firm Specifar Pharmaceuticals, bringing to an end a busy month of deal making in the non-branded drug sector.

News in brief

China arrests 263 in counterfeiting crackdown

31-May-2011 - Chinese authorities have arrested hundreds of people accused of manufacturing and selling fake pharmaceuticals in the country’s Zhejiang province.

EC adopts OIB categories for gelatin source BSE risk assessment

30-May-2011 - From July the EC will require that gelatin used in parenteral drugs is sourced from countries in World Organisation for Animal Health's (OIE) lowest risk categories for bovine spongiform encephalopathy (BSE).

News in brief

US FDA launches facility inspection database

30-May-2011 - The US Food and Drug Administration (FDA) has published a list of all the drug manufacturing facilities it has inspected between October 2008 and September 2010 as part of Government transparency efforts.

Two-stage development model needed to cut attrition rates, says expert

25-May-2011 - Pharma needs to learn from other sectors and abandon the multistage development paradigm in favour of a two-stage design and manufacturing model to cut attrition rates.

FDA oversight of J&J in Puerto Rico is “deeply troubling”

24-May-2011 - Fears the US FDA is mismanaging oversight of J&J in Puerto Rico are “deeply troubling”, said a US Congressman.

EU revises API certification doc to clarify appeal policy

19-May-2011 - The EDQM has revised its policy on withdrawal of API or excipient certification to clarify the appeal process.

News in brief

TGA launches ‘periodic update’ form for GMP compliance at overseas plants

18-May-2011 - The Australian Therapeutic Goods Administration (TGA) has introduced a new mechanism to help drugmakers maintain evidence of GMP compliance at manufacturing facilities outside the country.

Schott targets growth in Russia

16-May-2011 - Primary packaging maker Schott has joined the growing list of drug industry companies seeking to tap Russian government demand for increased domestic manufacturing.

Spin-off or demerger being considered by Aurobindo

11-May-2011 - Aurobindo Pharma is considering demerging its API and formulation businesses to unlock value and better serve clients.

FDA & USP extend relationship to modernise drug quality

10-May-2011 - The FDA and USP have expanded their collaboration to ensure the quality of medicines by modernising tests and standards.

Aceto aims API biz at ‘new’ and mature generics

10-May-2011 - Chemicals supplier Aceto Corp has its sights set on opportunities in the generic drug sector after soaring active pharmaceutical ingredient (API) and intermediates sales helped it to a strong set of quarterly financials.

Indian Carbogen plant meets HPAPI handling standards

09-May-2011 - Carbogen Amcis’s Indian plant has met industrial standards for the containment and handling of highly potent active pharmaceutical ingredients (HPAPI).

FDA approves Strides’ Indian oncology production plant

02-May-2011 - Strides’ oncology plant in Bangalore, India has been approved by the FDA, positioning the company to enter the US market.

Second draft of Excipact guidelines released for consultation

02-May-2011 - The second draft of Excipact, a set of certification standards for drug excipient producers being developed by the EFCG, FECC, IPEC and PQD, has been sent to industry stakeholders for consultation.

update

DSM says CMO biz model out of step with market; sales drop in Q1

28-Apr-2011 - Royal DSM NV says its pharmaceutical contract manufacturing business model is ‘out of step with market needs’ after the unit’s Q1 performance blots an otherwise positive set of financials.

Becton Dickinson updates on Japan ops; posts Q2 results

28-Apr-2011 - Becton, Dickinson and company (BD) has announced that production of its Hypak prefilled in Japan will resume later this year as operations in the country are recovering faster than expected.

USP and ChP forge stronger links with new appointments

27-Apr-2011 - The United States Pharmacopeial Convention (USP) and the Chinese Pharmacopoeia Commission (ChP) have made mutual executive appointments in an effort to further align drug quality standards.

News in brief

Sotax opens India unit

26-Apr-2011 - Tablet testing tech specialist Sotax has set up a new unit in India in the first stage of a five year plan to expand its business in the country.

US-wide track-and-trace called for to pre-empt state laws

20-Apr-2011 - Pharma, distributors and dispensers have all called for a single, US-wide track-and-trace standard that pre-empts state laws.