Cadila Healthcare says its formulation plant in Moraiya, Gujarat has passed a US Food and Drug Administration (FDA) inspection with no Form483 observations.
Janssen and Mundipharma have expanded their alliance through which Munipharma will sell, market, and promote medicines for the Belgium-headquartered pharma company.
Centurion Labs has recalled two lots of cold and allergy meds after the US FDA warned they may have been made at a Pharmatech LLC plant linked to a Burkholderia cepacia outbreak.
After receiving approval Kymriah, Novartis must prove it can handle the supply chain complexities of manufacturing high-value and time-sensitive CAR-T cell therapies, says logistics firm TrakCel.
The US FDA has warned a Florida-based clinic and seized vials of a smallpox vaccine in California used to create an unapproved product in a crackdown against "unscrupulous" stem cell firms.
The US FDA has released draft guidelines to identify trading partners in the pharma supply chain in accordance with the Drug Supply Chain Security Act (DSCSA).
The commercial compliance solutions company is expanding its footprint with a new office and anticipates further growth in the US and internationally to keep pace with client demand, says CEO.
Merck & Co has launched a promotional campaign featuring US singer and actress Mandy Moore, which marketing expert John Mack says targets America’s celebrity-obsessed market.
Bioprocessing suppliers have recently expressed optimism in the sector despite a slowdown in growth, and one expert believes this will drive investment in new tech and markets.
The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.
The US FDA has warned doctors not to use any liquid drugs made by PharmaTech LLC over renewed concerns they may be contaminated with the bacteria Burkholderia cepacia.
The US FDA has rejected Vernalis’ new drug application for its investigative cough and cold treatment CCP-08, which is the second time the firm has failed to win approval for a product this year.
More drugs were recalled in the US in the three months to the end of June than in any period since Q4 2014 according to analysis by Stericycle ExpertSolutions.
Public Health England has reserved NHS hepatitis B vaccine stocks for people at high risk of infection, citing shortages caused by production interruptions at Merck & Co and GSK.
The US FDA has rejected Valeant Pharmaceuticals International’s eye drop candidate following a site inspection at its subsidiary’s facility in Tampa, Florida, US.
The MHLW has ordered Pfizer, Bayer, Daichi Sankyo and firms selling generic warfarin and azithromycin in Japan to expand their products’ adverse event warnings.
Dr Reddy's says efforts to fix plant problems flagged by US FDA impacted its active pharmaceutical ingredient (API) business in the first quarter of fiscal 2018.
Lupin says it has already resolved a problem flagged in a Form 483 issued by US FDA inspectors who visited its Aurangabad manufacturing facility in July.
BASF SE has selected the Icertis Contract Management (ICM) platform to automate its contracting processes and improve visibility into contractual obligations and deviations.
Science Exchange has been certified under the EU-US Privacy Shield Framework after completing a seven-step process to demonstrate compliance with various data protection requirements.
Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA).
