29-Jun-2016 - Quality system and data integrity issues have landed two Chinese API makers with US FDA warning letters.
28-Jun-2016 - The Swiss drugs regulator saw a near-doubling in the number of inspections prompted by complaints or suspected infringements in 2015, according to its latest annual report.
27-Jun-2016 - Over 100 Colorado jobs could be lost following Pfizer’s decision to exit a former Hospira API plant by 2019.
23-Jun-2016 - India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.
22-Jun-2016 - AMRI has licensed technology needed to make an analytical standard drug firms working with cannabinoids can use for research and quality control.
21-Jun-2016 - Novacap has started building a sodium bicarbonate production facility in Singapore, citing Asian drug and food manufacturers as target customers.
17-Jun-2016 - The US FDA has banned Phalanx Labs from shipping products to the US after the Indian API and intermediates firm refused to let inspectors visit its site in Visakhapatnam.
16-Jun-2016 - Famar has said it will consider buying other US FDA approved facilities in Europe and North America.
16-Jun-2016 - Hovione has said the expansion of its API facility in East Windsor, New Jersey will create 60 jobs by 2019.
16-Jun-2016 - A plan to charge drug firms more to import APIs into India has won the support of the Government’s Drugs Technical Advisory Board (DTAB).
15-Jun-2016 - The UK MHRA has identified GMP deviations at two manufacturing sites operated by US firm Pharmaceutics International Inc (PII).
14-Jun-2016 - Nemus Biosciences has licensed rights to an in-vitro synthetic cannabinoid manufacturing method developed by Teewinot Life Sciences.
13-Jun-2016 - CDSCO has renewed a number of API firms’ ‘written confirmation’ documents – which are needed to ship to Europe – days after an industry group called for renewals without re-inspection citing trade concerns.
09-Jun-2016 - Risk algorithms and international agreements will help ensure imported API quality, says FDA Commissioner Robert Califf but industry must also take responsibility for its own supply chain.
09-Jun-2016 - Hovoine has opened a sales office in Osaka, Japan citing growing demand for generic APIs and manufacturing services.
08-Jun-2016 - Parties negotiating TTIP have discussed measures that would end EMA API and drug manufacturing plant inspections in the US and FDA inspections in Europe.
08-Jun-2016 - Micro Macinazione SA has upped storage capacity with a warehouse for high potency and narcotic drug actives in Molinazzo di Monteggio, Switzerland.
07-Jun-2016 - Carbogen Amcis plans to buy a GEA Pharma Systems facility in Bubendorf, Switzerland to support its API and ADC businesses.
06-Jun-2016 - Sun Pharma has agreed to sell two US oral solid dose manufacturing plants to Frontida BioPharm.
06-Jun-2016 - Organisations that identify API manufacturers whose manufacturing activities spread antimicrobial resistance will be considered alongisde other NGOs for a new European Commission award.
The International Conference of Harmonisation (ICH) guidance document on elemental impurities, Q3D, reached step 4 in December 2014, m...
Over the years, multiple active pharmaceutical ingredients (API) have been successfully combined into single dosage forms primarily th...
Valsynthese, expert in high energetic and hazardous fine chemical production of key intermediates and APIs, is devoted to delivering h...