Heritage announces a recall of lots of amikacin sulfate injection and prochlorperazine edisylate injection, due to evidence of selected products being non-sterile.
World Courier expands its commercial third-party logistics storage and distribution depots in strategic markets, as it continues its multimillion-dollar technology investment.
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.
Novartis initiates a recall of Promacta after its contract manufacturer introduced peanut flour into the same facility as the treatment, potentially causing cross-contamination.
As generic competition looms, Gilead donates 2.4 million bottles of Truvada to the CDC to aid in the center’s fight against the HIV epidemic in the US.
Par Pharmaceutical initiates a recall of mycophenolate mofetil injection, after a vial containing a glass fragment was discovered during reconstitution.
The Indian company announced that the US FDA issued observations for both its Indrad and Dahej facilities, as well as being required to expand its losartan recall.
The USTR stated that 20% of medicines on the Indian market were counterfeit, a claim that the country’s health secretary labelled as an ‘opposition to low-cost generics.’
The US FDA has issued draft guidance on the process of voluntary recalls, after a series of recalls involving sartan contamination with carcinogenic impurities.
Teva begins recall in the US of 35 lots of losartan tablets and Torrent expands its recall to include an additional 104 lots, after trace amounts of NMBA were discovered in both companies' products.
A US trade report identified that counterfeit drugs are becoming a greater issue through illegitimate online sales, particularly in countries such as China and India.
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.
Patients in Southern and Eastern Europe wait on average five times as long for the same treatments as patients in Northern and Western Europe, an EFPIA report finds.
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 European Commission approves Pfizer’s Vizimpro monotherapy for the first-line treatment of non-small cell lung cancer, as the market is projected to grow to $26.8bn by 2025.
GSK’s Dovato is approved by the US FDA for the treatment of individuals with HIV with no previous antiretroviral therapy, in a first for a two-drug, fixed-dose, complete regimen.
The company’s Mavenclad treatment gains approval from the US FDA for the treatment of multiple sclerosis, eight years after it had been initially rejected.
US FTC rules that Endo used its dominant position in the market to delay competition from Impax with an illegal pay-for-delay deal for its Opana ER product.
C2 Pharma acquires digoxin API product portfolio from Noblius to secure supply of the ingredient, after disruption of the supply of the API for a number of years.
Cure Pharma expands its DEA license to include authorization to manufacture both cannabis plant extracts and CBD within the scope of its patent portfolio.
Cambrex completes expansion of its R&D laboratory at its Milan site and adds a 12,000-liter reactor to its manufacturing facility during a $3m investment.
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.
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.
