07-Jul-2015 - Even if claims about Kumdang-2 are real, access to the drug and other pharmaceuticals in North Korea is limited to those who can pay black market prices according to a UK-based defector.
07-Jul-2015 - The European Commission last week officially added Israel and Brazil to a list of countries outside the EU that have standards of manufacture and supervision of APIs equivalent to those of the EU.
06-Jul-2015 - Toronto-based Attix Pharmaceuticals has received a US FDA warning letter after an inspection from November and a lack of corrective actions in the company’s response to the FDA.
06-Jul-2015 - GSK’s HIV unit ViiV Healthcare and China-based Desano Pharmaceuticals have forged an agreement whereby Desano will manufacture the API of GSK’s HIV drug Tivicay (dolutegravir) in China.
01-Jul-2015 - Europeans who want to fund organised crime can now do so more easily by buying medicines from web pharmacies that lack a new logo launched by the EC to stop the sale of fakes online.
01-Jul-2015 - GSK is investing £38m ($60m) in enzymatic manufacturing at an antibiotic facility in Singapore which the firm says is greener and more efficient than traditional approaches.
30-Jun-2015 - In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices) at all stages of the API supply chain.
29-Jun-2015 - Canada has asked importers to quarantine APIs made by India’s Polydrug Laboratories over concerns about its manufacturing plant in Ambarnath in Maharashtra.
25-Jun-2015 - API firm Saneca Pharmaceuticals has acquired struggling drug formulator Suir Pharma Ireland in a deal with former owner Mutares AG.
25-Jun-2015 - GSK and UK academics claim a newly identified enzyme is the missing link in the mechanism poppies use to make painkilling alkaloids like morphine and codeine and the anticancer compound noscapine.
24-Jun-2015 - Naming drugs using active pharmaceutical ingredients (API) rather than their salts will cut down on medication and dosing errors according to the US Food and Drug Administration (FDA).
22-Jun-2015 - As the death toll from MERS in South Korea edged to two dozen scientists there say the outbreak is different from in Saudi Arabia and also from its the related virus SARS.
22-Jun-2015 - Raffles PharmaTech has contracted ScinoPharm to make the API for a generic version of the arthritis pain drug celecoxib being developed for the US market.
17-Jun-2015 - Polydrug Laboratories chose not to log customer complaints about APIs made at its plants in Maharashtra according to Slovenian regulators.
15-Jun-2015 - South African regulators will continue to inspect all local and some international API sites despite relaxing facility assessment rules last week.
10-Jun-2015 - Crystallisation experts from across Europe will meet in France this month to share ideas and research that will shape how APIs are made in the future.
08-Jun-2015 - Swedish Orphan Biovitrum AB (Sobi) has pulled out of talks with a suitor that was rumoured to be US drug giant Pfizer.
08-Jun-2015 - Johnson Matthey saw revenue from (active pharmaceutical ingredients) APIs increase in fiscal 2015 despite competition from generic manufacturers and the relocation of a key customer.
04-Jun-2015 - European drug industry groups have contrasted 'misguided' cuts to the Horizon 2020 budget with US plans to increase NIH funding for science R&D under the 21st Century Cures Bill.
03-Jun-2015 - The US FDA has issued guidance to manufacturers on impurities in finished drugs which can change human DNA and cause cancer.
Samplestorage, handling anddelivery are as important in the determination of residual solvents as the analysis itself. This paper prov...
On December 19, 2014, the Guideline "ICH Q3D - Elemental Impurities" was issued by the ICH, providing a global policy for l...
Drug counterfeiting: a pharmaceutical industry problemCounterfeiters rely on two things: poorly secured pharmaceutical supply c...