Breaking News on Global Pharmaceutical Technology & Manufacturing

APIs (active pharmaceutical ingredients)

News headlines

Miracle cures and ‘hot motorbikes’ or black market meds and empty shelves: Pharma in North Korea

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.

Israel, Brazil added to list of countries with API GMP standards equivalent to EU

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. 

Canadian manufacturer hit with warning letter over cross-contamination issues

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.

GSK back in China via new API manufacturing agreement with Desano

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.

New logo will help patients tell legit EU web pharmacies from illegal sites says EC

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.

GSK investing $60m in greener manufacturing at Singapore amoxicillin plant

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.

ICH clarifies Q7 guidance on API GMP manufacturing

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.

Health Canada asks importers to quarantine Polydrug APIs over data concerns

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.

Saneca buys Europe's only independent, US FDA approved Beta-lactams plant

25-Jun-2015 - API firm Saneca Pharmaceuticals has acquired struggling drug formulator Suir Pharma Ireland in a deal with former owner Mutares AG.

UK scientists discover key poppy alkaloid production enzyme

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.

US FDA publishes API-salt naming policy

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).

South Korea mulls combining HIV drugs with antivirals to combat MERS

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. 

ScinoPharm to make API for Chinese drugmaker eyeing US celecoxib market

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.

Slovenian regulators slam Polydrug API plant in India

17-Jun-2015 - Polydrug Laboratories chose not to log customer complaints about APIs made at its plants in Maharashtra according to Slovenian regulators.

API plant inspections to continue despite rule change say South African 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.

Nucleation knowhow can aid API makers say crystal experts due to meet in France

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.


Sobi terminates talks with unnamed suitor

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.

Johnson Matthey: Ageing population and generics will drive API biz; Alfa Aesar sale on track

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. 

Pharma R&D exodus on the Horizon? EU industry bemoans funding cuts

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.

US FDA issues guidance on DNA-mutating pharma impurities

03-Jun-2015 - The US FDA has issued guidance to manufacturers on impurities in finished drugs which can change human DNA and cause cancer.

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