Germany-based CMO CPM Contract Pharma was hit with the first US FDA warning letter for failing to self-identify its manufacturing facility and pay the facility fee required by the Generic Drug User Fee Amendments of 2012.
Continued manufacturing problems at CMO Ben Venue Laboratories will cause an interruption of supplies of the cancer treatment Doxil in mid-to-late October, Janssen said.
The US House on Saturday passed legislation that calls for the tracking and tracing of pharmaceuticals through the nation's supply chain after agreeing on the bill with the Senate last week.
In the wake of recent bribery scandals, Boehringer Ingelheim (B-I) has called for stricter regulations in China, as it plans to triple production at its Shanghai manufacturing site.
West has begun production at its second manufacturing facility in China, driven by the growing market for pharma injectable components in the Asia pacific region.
A federal judge in the Southern District of Ohio has approved a US FDA consent decree against Shamrock Medical Solutions for drug manufacturing and labeling violations.
The global pharma packaging market - worth $47.5bn (Eur35.87bn) in 2011 - is expected to grow to $73bn in 2018, with a CAGR of 5.6%, according to a report by Transparency Market Research.
Cubist is issuing a nationwide recall of four lots of its antibiotic injection Cubicin after one of the company’s CMOs had a manufacturing issue that caused glass particulates to contaminate the lots.
The US FDA has released a Q&A to offer more clarity to GPhA, Cipla, Akorn and other drug and API manufacturers who responded to the initial stability draft guidance for ANDAs.
Jubilant HollisterStier (JHS) says expansion of its sterile manufacturing capacity at its facility in Kirkland, Canada will be used to fulfill several new contracts.
Molecular Profiles has received the regulatory thumbs up on a second manufacturing facility and says it can offer its clients a breadth of services uncommon for CMOs.
Cost of freight, customer service and regulatory compliance offer Western CMOs advantages over their Eastern Counterparts, according to US CMO Pharma Tech Industries (PTI).
SCM Pharma says its new contract manufacturing facility will cater for clients upscaling towards commercial production and the trend towards orphan drugs.
The US House of Representatives has passed a bill by voice vote that would for the first time create a system to track and trace drugs through the supply chain.
GlaxoSmithKline (GSK) says some manufacturing from the shuttering of an Australian packaging site will be picked up by Aspen and local third-party contractors.
Goodwin Biotechnology has teamed up with Coldstream Laboratories to offer clients ADC services as another example of biopharma demand driving contract manufacturing and development.
ATMI has started selling a new cGMP-compliant fill finish platform in a continuation of its focus on what it says is the growing single-use tech market.
One day after Purdue Pharma’s blockbuster opioid OxyContin lost its first patent, the US FDA has amended the drug’s label and now requires generic drugmakers to adopt similar abuse-deterrent formulations.
The expansion of CoreRx’s Clearwater, Florida facility will allow for hormone development, clinical trial and commercial manufacturing, and create about 25 new jobs.
India’s Directorate General of Foreign Trade (DGFT) has pushed back the deadline again for adopting new barcodes to track pharmaceutical exports by one year.
Hospira has announced it is voluntarily recalling multiple lots of five different injections because of customer reports of faulty packaging and contamination.
Hospira says bringing medical device manufacturing operations up to code will take 'a lot of work' after Lake Forest, Illinois plant is hit with US FDA Form 483.
European drugmakers are seeking between six months and a year to prepare and print updated product information, including the black symbol for drugs that require additional monitoring as part of their approval.
The US Food and Drug Administration (FDA) can require opioid generics to have abuse-deterrent properties if the same requirements are applicable to their brand name counterparts, FDA Commissioner Margaret Hamburg said in a letter to Rep. Fred Upton (R-Mich.)...