Guangdong Zhanjiang Jimin Pharmaceutical Co. has received a warning letter from the US FDA citing cGMP violations as well as unapproved new drug and misbranding charges.
Generic injectables are a solution to rising healthcare costs says Fresenius, which is expanding its US manufacturing network to benefit from the long-term growth prospects.
Fleming Laboratories has been banned from shipping APIs to the US by the FDA which says its manufacturing plant in Nawabpet, Telangana in India is not up to code.
The pharma world has converged in Frankfurt, Germany for this year’s CPhI Worldwide. In-Pharmatechnologist is here too to report the latest trends affecting the industry.
CordenPharma will supply Pfizer with highly potent active pharmaceutical ingredients (HPAPIs) from the facility in Boulder once earmarked for closure by the Big Pharma firm.
Pfizer, Merck & Co (known as MSD outside of North America) and GlaxoSmithKline (GSK) have come together to support the development of continuous manufacturing and bio-catalysis technologies in Singapore.
Siegfried Holding AG saw higher earnings in the first half of 2017 with cost synergies offsetting the negative impact facility maintenance work had on its API business.
CordenPharma Latina has resolved the problems that earned its API and injectable drug facility in Sermoneta, Italy a warning letter from the US FDA last year.
Price controls and procurement programmes would favour drugs containing locally-made APIs under a Government proposal designed to reduce India's reliance on imported ingredients and intermediates.
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 issued a complaint against an outsourcing facility that purportedly manufactured and distributed sterile drug products in violation of the DQSA.
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.
Takeda has agreed to pay $100m (€85m) upfront for rights to make and sell to Tesaro Inc’s drug Zejula in Japan, South Korea, Taiwan, Russia and Australia.
The Chinese pharmaceutical industry sets a positive outlook for regulatory harmonization as its Marketing Authorization Holder pilot program progresses.
French regulators says Chongquing Succeway Pharmaceutical Co Ltd should recall APIs made at its plant in Chongquing after inspectors found evidence of record manipulation and an undeclared manufacturing area.
The US FDA has called on Tubilux Pharma SPA to identify potential contamination sources at its eye medicine production plant in Italy in a warning letter this week.
India-based Alembic Pharmaceuticals has inaugurated its manufacturing facility in Panelav, Gujarat, where the firm will make generic oncology products for international markets.
Industry delegates say the US Food and Drug Administration (FDA) is showing increased support for continuous manufacturing, a stance C-SOPS told us is quality control-driven.
BASF has said it will build an ibuprofen plant in Ludwigshafen, Germany and increase production capacity for the API at a facility in Bishop, Texas in the US.
Baxter International has announced an agreement with India-based Dorizoe Lifesciences to develop over 20 generic injectables, a sector it says is growing annually.
Pfizer has recalled four injectables – including the already scarce heart surgery drug Sodium Bicarbonate - made at Hospira's facility in Rocky Mount, North Carolina after identifying a potential contamination risk.
The US FDA welcomes Scott Gottlieb to the helm, Actinium appoints adult leukaemia expert Richard Stone, and Bill Cheliak bring cannabinoid expertise to Tetra…
Cure Pharmaceutical has submitted a patent application for an oral film delivery technology it says can combine several active pharmaceutical ingredients without negative interaction.
