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Fresenius Kabi fined £500,000 after patient death

13-Jul-2015 - Fresenius Kabi and a UK drug manufacturer have been sentenced for supplying faulty insulin syringes which contributed to a diabetic man’s death.

Mylan recalls cancer and arthritis injectables

09-Jul-2015 - Mylan is expanding its recall of injectable Gemcitabine and Methotrexate batches after finding visible particulates.

FDA rule requires drugmakers to report manufacturing disruptions six months in advance

09-Jul-2015 - A new final rule from the US FDA now requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption causes a shortage.

Israel, Brazil added to list of countries with API GMP standards equivalent to EU

07-Jul-2015 - The European Commission last week officially added Israel and Brazil to a list of countries outside the EU that have standards of manufacture and supervision of APIs equivalent to those of the EU. 

European analytical lab network to speed nanomedicines to market

07-Jul-2015 - The EU has launched a €5m ($5.5m) programme across six facilities for characterising European nanomedicines.

Canadian manufacturer hit with warning letter over cross-contamination issues

06-Jul-2015 - Toronto-based Attix Pharmaceuticals has received a US FDA warning letter after an inspection from November and a lack of corrective actions in the company’s response to the FDA.

Hospira's Vizag plant begins sterile production following US FDA approval

02-Jul-2015 - Hospira has begun commercial production at a sterile injectable plant in India hit with several 483 forms after the US FDA deemed the site ‘acceptable.’

ICH clarifies Q7 guidance on API GMP manufacturing

30-Jun-2015 - In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer  (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices) at all stages of the API supply chain.

Health Canada asks importers to quarantine Polydrug APIs over data concerns

29-Jun-2015 - Canada has asked importers to quarantine APIs made by India’s Polydrug Laboratories over concerns about its manufacturing plant in Ambarnath in Maharashtra.

BIO 2015

Does second prequalified vaccine mark China as ‘true global player’?

23-Jun-2015 - China is set to become a major vaccines manufacturer for emerging markets once it untangles some regulatory quirks, says a panel at BIO 2015. 

Slovenian regulators slam Polydrug API plant in India

17-Jun-2015 - Polydrug Laboratories chose not to log customer complaints about APIs made at its plants in Maharashtra according to Slovenian regulators.

Hospira hit with Canada import ban over data integrity concerns

16-Jun-2015 - Health Canada has issued Hospira with an import ban over concerns about a testing lab at its manufacturing facility in Liscate, Italy.

US FDA upgrades Jubilant's troubled Washington plant to VAI

12-Jun-2015 - A Jubilant HollisterStier sterile manufacturing facility hit with a warning letter in 2013 has been upgraded following inspections by the US FDA last year.

CSIRO tells of sea shells that protect sensitive cures

09-Jun-2015 - A capsule inspired by the porous structure of seashells has been developed to protect drugs from extreme temperatures and could be used in controlled delivery.

Indian manufacturers struggling to stay on top of data integrity issues, EY survey finds

08-Jun-2015 - Despite increased scrutiny from regulators, one third of Indian pharma manufacturers and CMOs have yet to conduct a review to assess potential gaps in the assurance of data integrity, according to a new EY survey.

US preference for ANSI 363 excipient standards will change, says EXCiPACT

03-Jun-2015 - Multinational excipient-makers will drive US interest in EXCiPACT, the industry-led certification scheme says as a UK Colorcon plant becomes the eighteenth site to receive accreditation.

US FDA issues guidance on DNA-mutating pharma impurities

03-Jun-2015 - The US FDA has issued guidance to manufacturers on impurities in finished drugs which can change human DNA and cause cancer.

Czech API manufacturer hit with FDA warning letter over contamination, data issues

03-Jun-2015 - The US FDA has issued a warning letter to Czech API manufacturer VUAB Pharma for failing to properly respond to microbiological contamination and data integrity issues.

Lonza set to get commercial Adva-27a contract if cancer drug is approved

27-May-2015 - Lonza shipped a sample batch of a drug for resistant cancers this week and is set produce commercial supplies if the Phase I candidate goes on to be approved says Sunshine Biopharma. 

Intertek opens new drug stability testing facility citing demand and bigger med devices

26-May-2015 - Intertek has opened a new stability facility citing demand for bespoke drug and device services like abuse potential assessments and stress testing.

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