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Breaking News on Global Pharmaceutical Technology & Manufacturing

APIs (active pharmaceutical ingredients)

News headlines

US FDA slams two Chinese API makers for quality systems and data issues

29-Jun-2016 - Quality system and data integrity issues have landed two Chinese API makers with US FDA warning letters.

Swissmedic ramps up ad hoc inspections in 2015

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.

Pfizer takes axe to Hospira network, exiting 'under-utilised' Colorado plant

27-Jun-2016 - Over 100 Colorado jobs could be lost following Pfizer’s decision to exit a former Hospira API plant by 2019.

India to rewrite 75-year old drug laws with an eye on business, biologics and devices

23-Jun-2016 - India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines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.

AMRI licenses Teewinot's cannabinoid analytical standard production tech

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.

Novacap subsidiary starts work on pharma-grade sodium bicarbonate plant in Singapore

21-Jun-2016 - Novacap has started building a sodium bicarbonate production facility in Singapore, citing Asian drug and food manufacturers as target customers.

Phalanx Labs banned from shipping APIs to US after refusing inspection

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.

Famar will consider more plant acquisitions in Europe and North America

16-Jun-2016 - Famar has said it will consider buying other US FDA approved facilities in Europe and North America.

Hovione says New Jersey site expansion will create 60 jobs

16-Jun-2016 - Hovione has said the expansion of its API facility in East Windsor, New Jersey will create 60 jobs by 2019.

Indian drug advisory board backs proposed API import license fee hike

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).

correction

The strife of Pii: UK MHRA finds GMP deviations at two facilities

15-Jun-2016 - The UK MHRA has identified GMP deviations at two manufacturing sites operated by US firm Pharmaceutics International Inc (PII).

Nemus licenses synthetic cannabinoid production tech from Teewinot

14-Jun-2016 - Nemus Biosciences has licensed rights to an in-vitro synthetic cannabinoid manufacturing method developed by Teewinot Life Sciences.

CDSCO renews API firms' 'written confirmations' days after industry raises trade concerns

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.

DISPATCHES FROM BIO 2016

US FDA Commissioner Califf calls on industry to tackle supply chain quality issues

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.

Hovione aims to be big in Japan, citing growing demand for generic APIs

09-Jun-2016 - Hovoine has opened a sales office in Osaka, Japan citing growing demand for generic APIs and manufacturing services.

update

TTIP negotiators mull end of duplicate US, EMA facility inspections

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.

Micro Macinazione opens narcotic and high potency APIs warehouse

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.

Carbogen Amcis to buy GEA plant and convert it for API production

07-Jun-2016 - Carbogen Amcis plans to buy a GEA Pharma Systems facility in Bubendorf, Switzerland to support its API and ADC businesses. 

Sun sells two more US manufacturing plants

06-Jun-2016 - Sun Pharma has agreed to sell two US oral solid dose manufacturing plants to Frontida BioPharm.

EC to reward NGOs that identify API manufacturers that pollute

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.

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