SUBSCRIBE

Breaking News on Global Pharmaceutical Technology & Manufacturing

Regulations

News headlines

Cardboard and brown agglomerates: FDA slams Pfizer injectables plant

01-Mar-2017 - Particulate problems in sterile injectables and poor aseptic techniques landed Pfizer with a US FDA warning letter at a former Hospira facility in Kansas.

Fosun-owned API maker Chongqing criticized by US FDA

01-Mar-2017 - Lab staff at an API plant run by Chongqing Pharma Research Institute Co., Ltd. deleted out of spec test results according to the US Food and Drug Administration (FDA).

GSK seeks advice on planned Scottish respiratory API plant

28-Feb-2017 - GSK has asked Angus Council for advice as it prepares to submit a planning application for an API plant it intends to build at its site in Montrose, Scotland.

Pharma Outsourcing & Partnership Global Congress 2017 Europe

Vital statistics? Big Pharma undervaluing commercial data, expert

27-Feb-2017 - Data is a core competence for Big Pharma that should not be outsourced, according to an industry statistics expert.

Gov’t delay could postpone ClinicalTrials.gov usability, patient recruitment

23-Feb-2017 - Several organizations have penned an open letter to NIH urging it adhere to 21st Century Cures deadlines that if missed, will affect improvements to ClinicalTrials.gov – and ultimately, study start up.

Dr. Reddy's' Miryalaguda plant issued with Form483 after US FDA audit

23-Feb-2017 - Dr Reddy’s Laboratories has been issued with a Form483 after an inspection at its active pharmaceutical ingredient (API) plant in Miryalaguda in Telangana, India.

Opinion

Raging bull' - Vaccines don’t cause autism and saying otherwise costs lives

22-Feb-2017 - Vaccines do not cause autism and people who say otherwise are wrong.

AmpTec looking to achieve full GMP compliance for APIs

21-Feb-2017 - AmpTec GmbH is in the process of achieving full GMP compliance for API manufacturers in order to expand its offerings into the clinical space.

Cancer drug plant likely source of radio isotope detected across Europe say experts

21-Feb-2017 - A radiopharmaceuticals plant is the most likely source of the radioactive iodine-131 detected in several countries in recent weeks according to experts.

News in brief

Takeda pulls Danish paracetamol batch after two packs found to contain ibuprofen

20-Feb-2017 - Takada Pharma A/S has recalled a batch of its Pamol paracetamol tablets in Denmark after two packs were found to contain ibuprofen.

Tilray begins shipping medical marijuana to more countries

20-Feb-2017 - Medical marijuana developer Tilray has begun shipping to overseas patients and trial sites outside Canada after partnering with local distributors to comply with regional regulations.

Pfizer hit with US FDA warning at Kansas generic Copaxone site

20-Feb-2017 - The US FDA has issued a warning letter to the former Hospira fill and finish facility in McPherson, Kansas – now part of Pfizer’s contract manufacturing business CentreOne.

Is the return of the one-stop-shop model just a CMO marketing ploy?

16-Feb-2017 - End-to end service offerings are a differentiator within the fragmented CMO industry and not driven by pharma demand, a Results Healthcare report says.

Dr. Reddy's Laboratories continues European hospital market expansion

16-Feb-2017 - Dr. Reddy’s Laboratories Ltd has said it may invest in additional manufacturing capacity to support its efforts to grow in the European hospital drug market.

Quotient buys QS Pharma in latest US expansion move

15-Feb-2017 - Quotient Clinical Ltd. has bought Charles River Laboratories’ contract manufacturing business, QS Pharma LLC.

News in brief

Sun Pharmaceutical Industries sees API sales slide in Q3

15-Feb-2017 - Sun Pharmaceutical Industries Ltd. saw lower active pharmaceutical ingredient (API) revenue in the third quarter of fiscal 2017.

US FDA says Japanese OTC firm Sato must do more to fix plant problems

15-Feb-2017 - The US FDA says Sato Pharmaceutical Co., Ltd. has not addressed environmental monitoring shortcomings at its Tokyo plant.

Indian API maker slammed by US FDA for water and cleaning issues

14-Feb-2017 - The US FDA has issued a warning letter to Indian API maker Resonance Laboratories Private Limited citing inadequate cleaning procedures at its facility in Bangalore.

GSK on America First: US will not be able to own every part of supply chain

13-Feb-2017 - GSK has warned that Donald Trump’s plan to encourage US drug production through import tax hikes must take the global nature of pharma supply chains into account.

India asks drug firms to help discourage off-prescription antibiotic sales

13-Feb-2017 - Indian regulators want manufacturers to discourage pharmacists from selling antibiotics to patients without prescriptions as part of an effort to curb the spread of superbugs.

Related News

Key Industry Events

 

Access all events listing

Our events, Shows & Conferences...

Product Innovation