Breaking News on Global Pharmaceutical Technology & Manufacturing

APIs (active pharmaceutical ingredients)

News headlines

Echo's cannabis API delivery formulation could aid low solubility drugs

30-Jul-2015 - A drug delivery platform which increased the bioavailability of a cannabis-based drug candidate 30% could be used to boost solubility of other APIs, says Echo Pharmaceuticals.

'Rough notes' and backdated signatures land Indian API maker US FDA warning

29-Jul-2015 - Issues with batch production records at an Indian facility have landed API maker Mahendra Chemicals with a US FDA warning letter.

FDA offers draft guidance on quality metrics used to assess drug manufacturing

29-Jul-2015 - New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that they use to make drugs and biologics.

Sandoz shutters German and Indian production sites

23-Jul-2015 - Sandoz has revealed it will close three manufacturing sites in Germany and India.

Capsugel expanding Encap plant on rising HPAPI demand

23-Jul-2015 - Capsugel is doubling the size of a facility in Scotland to support demand for the encapsulating of drugs containing high-potency active pharmaceutical ingredients (HPAPIs).

Ethiopia: GMP compliant local drug and API sector would yield health and economic benefits

22-Jul-2015 - Ethiopia will start making its own APIs in 2020 according to the Government which says local manufacture will improve access to medicines, curb sale of counterfeits and promote innovation.

Lonza: global hedge helped offset currency exposure but Visp still a risk

22-Jul-2015 - Lonza has reported higher revenues and profits for H1 2015, but warned that the strength of the Swiss franc means its Visp facility is still finding it hard to compete.

Johnson Matthey’s API business flat in Q1 on timing of opiate API orders

22-Jul-2015 - Johnson Matthey saw lower demand for opiate APIs in the three months to the end of June, which offsett more solid performance by its attention deficit hyperactivity disorder (ADHD) drug actives.

Gadea's steroid intermediates biz means AMRI not reliant on Asian suppliers say execs

20-Jul-2015 - AMRI has bought Spanish contractor Gadea Pharmaceutical Group for $174m (€160m) to add muscle to its steroid API business and sign up more customers outside the US.

Green GMP criteria would help responsible API firms compete with polluters says DSM Sinochem

20-Jul-2015 - API firms that invest in waste management find it hard to compete with those that pollute according to DSM Sinochem, which wants environmental criteria included in GMP standards for environmental and business reasons.

Nordea mulling holdings in drugmakers that source APIs from water polluters

16-Jul-2015 - Drugmakers risk losing financial backing if they source APIs from Indian suppliers that pollute according to Nordea Asset Management's head of responsible investments, Sasja Beslik.

News in brief

Pfizer to close Mumbai manufacturing facility

16-Jul-2015 - With no active production at the plant since 2013, the company said it would shutter its Mumbai, India-based facility in mid-September, according to a Bombay Stock Exchange filing . 

Sandoz closing Mumbai API plant but says it remains committed to India

15-Jul-2015 - Sandoz will shutter an Indian API facility in 2016 as part of a manufacturing refocus in the region.

Environmental group welcomes DSM-Sinochem and GSK efforts to halt spread of antibiotic resistance

13-Jul-2015 - Antibiotic API makers have an obligation to ensure their activities do not spread resistance says a group that welcomed DSM-Sinochem’s commitment to environmentally-friendly production.

Did you pay your GDUFA fees? 29 drugmakers didn't, says US FDA

13-Jul-2015 - Almost 20 API makers – mostly from India and China – have been cited by the US FDA for failing to pay their annual facility fees.

FDA rule requires drugmakers to report manufacturing disruptions six months in advance

09-Jul-2015 - A new final rule from the US FDA now requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption causes a shortage.

Hovione upping spray drying capacity to support rise in low solubility drugs

08-Jul-2015 - A new unit will up Hovione’s spray drying capacity 20% as it predicts a surge in demand for such a service in overcoming drug solubility issues.

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.

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