Processing equipment

Remediation activities at non-GMP compliant site ‘progressing well’, says Recipharm

25-Oct-2018 By Flora Southey

An MHRA audit of Recipharm’s facility in Ashton-under-Lyne has revealed the CDMO was deficient in certain manufacturing procedures for potent products.

Korean drugmaker lands US FDA warning for aseptic practices and backdated records

18-Oct-2018 By Flora Southey

According to the US FDA, a facility inspection revealed operators leaned their heads and torsos over open containers while clearing bottle jams, before restarting the aseptic line.

Dr. Reddy’s continues sell-off to Neopharma with Hyderabad API plant

16-Oct-2018 By Maggie Lynch

Dr. Reddy’s Laboratory has decided to sell its API manufacturing plant to generics joint venture, Therapiva.

Sun Pharma adds $1.6m sterile manufacturing line in Guwahati, India

15-Oct-2018 By Flora Southey

Sun Pharma has installed a parenteral drug production line in Guwahati for the manufacture of sterile products.

CPhI Worldwide 2018

Particle Sciences boosts manufacturing services with Pennsylvania site

15-Oct-2018 By Flora Southey

The 5,000-square-foot expansion responds to client demand, says president Robert Lee: “The market for services is growing, yet the supply of CMOs interested in taking on these complex drug products is not.”

CPhI Worldwide 2018

Ireland’s largest generics maker invests €86m, targets US market

11-Oct-2018 By Flora Southey

As part of the investment, Chanelle Pharma will build a €11m manufacturing facility for liquid generic products in Galway, for export to the US.

eTheRNA guarantees mRNA supply with Belgian manufacturing site

11-Oct-2018 By Maggie Lynch

eTheRNA announced it will be opening a cGMP compliant mRNA manufacturing facility in Belgium, to increase production of its three mRNA encoding proteins.

CPhI Worldwide 2018

CPhI 2018: Dispatches from Madrid

11-Oct-2018 By Flora Southey

Following stints in Paris and Frankfurt, CPhI Worldwide has again set up in Madrid for three days of insight briefings, biopharmaceutical tracks and networking.

NEWS IN BRIEF

Infrared inspection tech to identify API errors

10-Oct-2018 By Staff Reporter

SEA Vision says its HarleNir technology can identify errors on the manufacturing line, even if the product appears visually sound.

Continuous manufacturing: When will everyone be doing it?

05-Oct-2018 By Ben Hargreaves

The answer, according to consultant Emil Ciurczak, is in 10 years – at least, if generics manufacturers and CMOs want to be competitive.

Bosch to present oral solid dosage production device

03-Oct-2018 By Maggie Lynch

Bosch packaging technology will showcase its laboratory device for oral solid dosage forms, Xelum R&D for continuous manufacturing.

Small CDMO targets SMEs with spray drying tech in Spain

03-Oct-2018 By Flora Southey

As a relatively small CDMO, Idifarma fits better with small and medium size companies’ goals, costs and flexibility, says executive.

UK pharma marketing agency sets up in Massachusetts hub

02-Oct-2018 By Flora Southey

CMO-focused marketing and PR agency, ramarketing, has signed a lease on offices in the rapidly growing pharma and biotech hub of Cambridge, Massachusetts.

Cambrex cements North Carolina presence with buildings purchase

01-Oct-2018 By Maggie Lynch

Cambrex, a small molecule and API manufacturer, announced it will expand to establish a ‘center of excellence’ for process and development of its API clinical supply.

Delays at MSD’s CMO prompt Sinemet shortage

01-Oct-2018 By Flora Southey

MSD has warned regulators to expect a shortage of its Parkinson’s medicine, Sinemet, due to production constraints at a contract manufacturer’s facility.

Evonik expands API and advanced intermediates manufacturing with €36m investment

26-Sep-2018 By Maggie Lynch

Evonik completed a €36m expansion of its contract manufacturing capabilities of API and advanced intermediates in the US and Europe.

Avista upgrades facility to expand testing capabilities

25-Sep-2018 By Maggie Lynch

Avista Pharma Solutions, a Massachusetts based CDMO, has announced plans to upgrade its facility in Agawam, Massachusetts to increase its offerings.

Switzerland to Canada: GSK transfers Voltaren tech for local supply

21-Sep-2018 By Flora Southey

GSK has invested $27.8m into manufacturing operations in Canada, including a technology transfer of Voltaren products from facilities in Switzerland to Mississauga.

BAYER UPDATE

Pfizer, Merck and Novartis to shut manufacturing sites as hurricane looms

13-Sep-2018 By Maggie Lynch & Flora Southey

Major pharmaceutical companies and CMOs in the US have announced emergency contingency plans, including facility closures and the relocation of drug products, as Hurricane Florence approaches southeastern shores.

NEWS IN BRIEF

UK seizes unlicensed meds ‘home-made’ in cement mixer

12-Sep-2018 By Flora Southey

Three family members charged with producing and supplying unlicensed medicines in the UK used pressing equipment and dyes imported from China, says MHRA.

Blockchain advancements to come from Tjoapack and Veratrak partnership

30-Aug-2018 By Maggie Lynch

Tjoapack and Veratrak partnered to establish the use of blockchain technology across the pharmaceutical industry for the first time in a GxP environment.

GSK to exit manufacturing site in Ireland, cuts 165 jobs

20-Aug-2018 By Flora Southey

Disappointing sales prompted the decision to close GSK’s skincare manufacturing facility in Sligo, Republic of Ireland.

Pfizer signs $425m mRNA flu vaccine agreement with BioNTech

20-Aug-2018 By Maggie Lynch

BioNTech signed a collaboration agreement with Pfizer to conduct joint research on a mRNA-based flu vaccine.

Catalent completes Juniper merger to ‘expand and strengthen’ oral dose manufacturing

14-Aug-2018 By Flora Southey

Juniper Pharmaceuticals will become a wholly owned subsidiary of Catalent Pharma Solutions today, says the CDMO.

Mylan aims to ‘reduce complexity’ at Form 483-hit plant

13-Aug-2018 By Ben Hargreaves

In a second quarter call with investors, president of Mylan, Rajiv Malik, stated the company has undertaken a restructuring and remediation plan at its Morgantown, West Virginia plant.

Korea round-up: Janssen exits plant, Bayer transfers manufacturing

08-Aug-2018 By Flora Southey

Janssen has confirmed plans to close a supply chain facility in HyangNam, while Bayer is transferring manufacturing operations from Ansung, South Korea, to Berlin, Germany.

Fukoshima-based API maker receives US FDA warning over unreported data

02-Aug-2018 By Flora Southey

Unreported electronic data and a lack of review criteria and methodology were cited in the US FDA warning letter.

GSK closes Bangladesh manufacturing plant, sheds 1,000 workers

31-Jul-2018 By Maggie Lynch

GSK is shutting down its Bangladesh manufacturing plant in an effort to streamline its emerging market operations, laying off 1,000 employees in the process.

ACG becomes India’s first in-house packaging provider for oral solid meds

26-Jul-2018 By Ben Hargreaves

ACG has expanded its capabilities by completing its work on a lamination facility to be able to complete all packaging requirements for solid oral medication in-house.

Cobra, Pfizer, GE Healthcare safe in Sweden fires

25-Jul-2018 By Flora Southey

The dozens of ‘devastating, unprecedented and dangerous’ forest fires raging across Sweden are far from manufacturing and industrial centres, says Swedish Association of the Pharmaceutical Industry.

Cambrex enters finished dosage market with $425m Halo Pharma acquisition

23-Jul-2018 By Flora Southey

API maker Cambrex Corporation will add drug development and finished dosage capabilities to its network with the acquisition of CDMO Halo Pharma.

Novartis seeks out-licensing partners as it exits antibiotics R&D

17-Jul-2018 By Flora Southey

Novartis says it will discontinue antibacterial and antiviral research to free-up resources for core focus areas.

Wasdell gets serialisation-ready ahead of EU and US deadlines

13-Jul-2018 By Staff Reporter

Wasdell Group has launched a serialisation service, with optional three-tier aggregation, ahead of EU and US implementation deadlines.

Sanofi halts manufacturing amid pollution claims at French plant

12-Jul-2018 By Flora Southey

Sanofi has suspended production at a French manufacturing facility it says released solvents into the atmosphere.

PA to NJ: Teva accepts $40m tax savings to relocate US HQ

09-Jul-2018 By Flora Southey

Teva says relocating US headquarters from Pennsylvania to New Jersey is part of its “significant restructuring plan.”

NEWS IN BRIEF

ChargePoint reports 399% growth in China

04-Jul-2018 By Flora Southey

After announcing expansion plans across the Americas, ChargePoint says it is growing its presence in Asia.

Catalent eyes early-phase work with $133m Juniper acquisition

03-Jul-2018 By Melissa Fassbender

Catalent is set to acquire Juniper Pharmaceuticals in a $133m deal, which will provide the CDMO with a new European hub and the ability to win a larger share of early-phase development programs says exec.

NEWS IN BRIEF

Orion signs VagiVital commercial supply deal, oversees tech transfer

21-Jun-2018 By Flora Southey

Orion Contract Manufacturing will make, package, and supply Peptonic Medical’s over-the-counter VagiVital product, which is set to launch later this year.

Adents launches NovaTrack: 'Blockchain will help secure certain parts of track and trace'

20-Jun-2018 By Flora Southey

Adents has combined artificial intelligence and Microsoft Blockchain-based technology to help secure and analyse transactions across the supply chain.

Recipharm buys Sanofi CMO site in UK, signs long-term supply deal

18-Jun-2018 By Flora Southey

Sanofi is handing off its Holmes Chapel facility and all existing contract manufacturing agreements to CDMO Recipharm.

WuXi STA: China approves first CMO-made new drug

14-Jun-2018 By Flora Southey

The first candidate made in accordance with China’s Marketing Authorisation Holder pilot programme has received new drug application approval.

NEWS IN BRIEF

Alcami supporting commercial supply of Flexion’s first FDA-approved product

13-Jun-2018 By Melissa Fassbender

Alcami began work on Flexion Therapeutics's ZILRETTA in the fall of 2014 and today announced that it will further support commercial supply of the product, which is approved for the treatment of OA-related knee pain.

FUTURELINK 2018

Serialisation legislation could improve recall process for drugmakers, says exec

13-Jun-2018 By Flora Southey

Impending EU serialisation regulations could enhance drug recall procedures for pharmaceutical companies, says executive.

Cambrex expands in Italy and Sweden: New hires, labs to be ready in 2019

13-Jun-2018 By Melissa Fassbender

Cambrex’s news that it will be constructing a research and development laboratory at its Italy-based site follows on the heels of its recently announced plans to begin a $5m expansion in Sweden.

FUTURELINK 2018

Blockchain the perfect fit for digital supply chain? Industry not convinced

11-Jun-2018 By Flora Southey

Blockchain is gaining momentum in the pharmaceutical industry, but consultant Pasi Kemppainen says he would be “cautious” to implement the technology across the entire digital supply chain.

Emergent initiates $50m expansion, expects to hire 60

07-Jun-2018 By Melissa Fassbender

Emergent BioSolutions has initiated a $50m multi-year expansion at the company’s Baltimore, MD-based fill/finish facility.

Six-month serialization countdown in US: Think strategy and lead times, says CPO

04-Jun-2018 By Flora Southey

Drugmakers should allow time to test packaging and implement changes if needed, before the November DSCSA deadline, says contract packaging organization.

Recalled oral contraceptive packaged at Sharp Packaging Solutions, says Allergan

29-May-2018 By Flora Southey

Placebo capsules packaged out of order in Allergan’s Taytulla oral contraceptive blister pack have prompted a voluntary recall in the US.

Avara to buy Novartis site, signs sterile injectables supply deal

29-May-2018 By Flora Southey

Avara Pharmaceutical Services has agreed to buy Novartis’ sterile manufacturing facility and development centre in Quebec, Canada.

Researchers target rapid changes to downstream continuous manufacturing

29-May-2018 By Nick Taylor

Academic research underpins many of the early success stories in continuous manufacturing. Now, Blair Brettmann and her team are working to write another chapter by applying electrospinning and other techniques to downstream processing.