The US FDA has refused to reapprove Sun Pharma Advanced Research LTD’s epilepsy drug Elepsia XR (levetiracetam) citing problems at its plant in Halol, India.
Burkholderia cepacia contamination is a risk for drug makers according to the US FDA, which says only rigorous testing can ensure the safety of non-sterile, water-based products.
Aptar Pharma has acquired 20% of the US-based company, Kali Care, less than two months after inaugurating its first facility outside of France as it aims to expand globally.
The US FDA has accused Vikshara Trading & Investments Ltd. of giving false statements about a strike to delay the inspection of an Ahmedabad API plant later found to be non-compliant.
The US FDA has identified problems at Dr Reddy’s generic drug manufacturing site in Bachupally, India according to a filing on the Bombay Stock Exchange (BSE).
The US FDA has handed Sun Pharmaceutical Industries Ltd a Form 483 detailing critical observations made during an inspection of its Dadra, India facility.
The EMA and US FDA say they agree on how pharmaceutical firms should include quality-by-design (QbD) elements in drug approval and manufacturing change applications, citing a recently completed pilot collaboration.
India has told state regulators to inspect API sites making oxytocin in an effort to prevent the hormone being used to speed up childbirth without medical justification.
A Combino Pharm dosage form plant in Malta has passed a US FDA inspection according to parent Medichem, which says it is now poised to expand its US business.
As many as 400 contract manufacturing organisations (CMOs) will not be ready for upcoming US and EU track-and-trace regulations, says supply chain services firm TraceLink.
The US FDA has criticised Badrivishal Chemicals & Pharmaceuticals for failing to document production and monitor the efficacy of water purification systems at its API plant in Maharashtra.
The US FDA has told Scynexis not to start trials of an injectable formulation of its candidate antifungal Scy-078 after several volunteers developed blood clots during a Phase I study.
The Danish Medicines Agency (DKMA) has cleared Europharma DK ApS to resume drug sales and distribution after the firm appointed a new managing director.
A second Megafine Pharma plant has landed a US FDA warning letter for cGMP violations, including sourcing API intermediate materials from a facility on import alert.
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).
Particulate problems in sterile injectables and poor aseptic techniques landed Pfizer with a US FDA warning letter at a former Hospira facility in Kansas.
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.
Dr Reddy’s Laboratories has been issued with a Form 483 after an inspection at its active pharmaceutical ingredient (API) plant in Miryalaguda in Telangana, India.
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.
API manufacturer Stada Arzeneimittel AG has received an acquisition offer from private equity firm Cinven Ltd., and an expression of interest from Advent International Corp.
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.
Symbiosis has opened an office in Boston, Massachusetts citing growing demand for vial filling services for highly potent APIs and large molecule injectable formulations.
Mezzion has hired Pol Pharma and Halo Pharma and accused former CMO Dr Reddy’s of hiding manufacturing problems that cost its erectile dysfunction candidate, udenafil, US approval.
The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.
A Wockhardt facility in India put under import alert last year has received a US FDA warning letter citing issues ranging from data discrepancies to inappropriate aseptic clothing.
Bangalore’s Strides Shasun Ltd. has acquired Perrigo API India ltd and its active pharmaceutical manufacturing portfolio for generics for INR1bn ($14.7m).
Baxter International has agreed to pay Claris Lifesciences $625m (€598m) for three manufacturing facilities and a portfolio of 11 approved injectable drugs.
Fareva Group has set up an aerosol manufacturing facility at its site in Richmond, Virginia as part of a $40m (€37m) investment in its drug, OTC medicine and beauty care business.
Breckenridge Pharmaceutical has entered into a multi-product marketing agreement with development and manufacturing partner Gland Pharma Limited for seven injectable products.
Dongying Tiandong Pharmaceutical Co., Ltd does not do enough to ensure the crude heparin it uses is free potentially lethal contaminant OSCS according to the US FDA.
