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US and India receive most warning letters from FDA
New research has found that of the 38 warning letters handed out by the FDA in 2019, the US and India received the vast majority.
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Drug Manufacturing
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Complete response letter sent for two generic products
A complete response letter (CRL) has been sent to Dr Reddy’s for two generic products.
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Cannabinoids in pharma series: cannabinoids on the market today
This series investigates the growing interest from the pharmaceutical industry in cannabinoids. In this first piece, we hear from industry experts about the current situation of the ingredient on the pharmaceutical market.
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Letter highlights issues with US drug returns verification requirements
An open letter has underscored the challenges of return failure in the US drug supply chain, especially after the introduction of the Drug Supply Chain Security Act in November.
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The Nagoya Protocol: sharing the benefits of pharmaceutical products and protecting biodiversity
Researchers use the Earth’s biodiversity for pharmaceuticals, but this is under threat due to climate change and habitat destruction. The Nagoya Protocol aims to conserve these resources in a sustainable way.
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Swine fever in China raises concern over heparin supply for US
The US supply of heparin, an ingredient used in anticoagulant drugs and found in pigs, is under threat due to an outbreak of disease in Chinese herds.
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Case study: Merck Leverages Data and Analytics to Support New Continuous Drug Manufacturing Processes
Over the past couple of years, the European Medicines Agency and US Food and Drug Administration have given approvals to a handful of pharmaceutical companies to manufacture drug products using continuous manufacturing processes.
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RUXIENCE™ biosimilar granted approval from FDA
The FDA has approved RUXIENCE (rituximab-pvvr), a biosimilar to Rituxan® (rituximab), for treatment of non-Hogkin’s lymphoma and other conditions.
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Downstream processing market will grow to record $40bn by 2026
The global downstream processing market is predicted to witness record-breaking growth due to a surge in the adoption of biotech processes.
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Sickle cell drug wins Priority Review by the FDA
The US Food and Drug Administration (FDA) has given an investigational sickle cell medicine, crizanlizumab (SEG101), Priority Review.
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Drug manufacturer planned to shred cGMP documents ahead of inspection
An Indian pharmaceutical company was planning to shred quality control records ahead of an FDA inspection, found officials.
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Amgen wins patent block on Sanofi drug rival
Amgen has successfully blocked the manufacture, sales and marketing of its Sanofi drug rival in Germany.
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Controlled release drug delivery market to rise 14.3 percent
The global controlled release drug delivery market will be worth an estimated $91.2 billion by 2026, according to a new study.
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FDA publishes guidance for Inactive Ingredient Database
The FDA has released draft guidance for using the Inactive Ingredients Database to aid drug developers.
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FDA sends warning letter to sterile injectables plant
A pharmaceutical manufacturing site in New Jersey receives FDA warning letter for failing to thoroughly investigate quality problems and data integrity issues.
