Indoco confirms receipt of a warning letter from the US FDA and the agency posts details of a Form 483 for two different facilities in the space of one week.
The two regulatory agencies have confirmed the addition of the last country to their mutual recognition agreement, with GMP inspections by Slovakia given a positive assessment.
Highlighting the threat of AMR, the UK government has worked with the pharma industry to develop a new antibiotics payment model based on ‘usefulness’ to the NHS.
Strides’ Puducherry, India, facility has received a warning letter from the US FDA, which the company announced will lead to deferrals for 10 pending ANDA approvals.
The strategic advisory company, Trinity, opens a new office in Germany, with leadership joining from Syneos Health to work “hand-in-hand” with biopharma clients.
With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.
The value generated by the manufacture of medicines has doubled since 2000, with one of the smallest countries in Europe responsible for a significant proportion of the total figure.
US FDA delivers a Form 483 with four observations to Sun Pharma, with one noting that the company took eight years to create design plans for the production of one product.
Zenith-Cognizant Technologies emerges from an acquisition aimed to streamline solutions as more complex “smart factories” become a greater focus in the biopharmaceutical industry.
To investigate blockchain processes and make distribution information retrieval more efficient, the FDA tapped big name companies for a supply chain security pilot program.
Aurobindo has received another Form 483 from the US FDA, after the agency found its response to complaints were ‘not always sound’ for products destined for the US market.
EMA assembles pharmaceutical developers to strengthen antimicrobial pipelines while, in the meantime, a study found the world’s rivers dangerously contaminated.
Although the industry may not be among the ‘frontrunners’, Novo Nordisk is seeing the benefits when it comes to recruitment and developing mutually beneficial partnerships, says director.
Heritage announces a recall of lots of amikacin sulfate injection and prochlorperazine edisylate injection, due to evidence of selected products being non-sterile.
University of Rochester Medical Center joined the global health research network aiming to ‘expand its access to advanced clinical trials’, TriNetX announced.
CRF Bracket is expanding its offering across the Asia-Pacific region with a new Tokyo office to help it better serve the area’s diverse and underserved patient population.
As WuXi STA expands its facility footprint in China, a VP of the company explains how global regulatory approvals fit with strategic plans for services to be concentrated geographically.
Senator Flake will discuss regulatory guidance impacting innovation and his perspective on the state of the industry during his keynote address at CPhI North America.
Jordan-based MS Pharma announces the acquisition of the Greek generic manufacturer Genepharm, aiming to add cardiovascular, CNS and oncology products to its portfolio.
Novotech signs on two major hospitals to its CRO partnership program in South Korea – a market seeing greater interest from North American and European companies.
An observation by the US FDA notes that Aurobindo had no established control procedures to monitor its manufacturing process, resulting in batches contaminated with unidentified material.
The Brazil-headquartered antibiotics company announces that it has invested in two new buildings, a few years after running into regulatory trouble due to non-compliance with cGMP.
Synteract is opening a new office in Swansea, Wales in response to increased demand across its core therapeutic areas for both full-service work and more consultative, standalone projects, says CEO.
There is a common and often unchallenged perception that manufacturing quality standards in pharmerging countries are worrisome, but Lee Newton of Lonza argues this is not the reality.
The global software consulting company N-Side recently launched an end-to-end clinical trial supply chain management solution to enable “agile” decision making and reduce drug waste.
US FDA announces that a new generic for valsartan will reach the market, after prioritising the review of the product to alleviate shortages resulting from recalled products.
