Processing equipment

Novo Nordisk pumps $22m into insulin manufacturing site

06-Dec-2018 By Flora Southey

The Danish drugmaker has announced another investment at its diabetes finished products manufacturing facility in North Carolina, US.

Biovation invests in equipment able to create any tablet on the market

04-Dec-2018 By Maggie Lynch

Biovation expands its technology portfolio with all-encompassing tableting equipment to grow its production capacity and change specifications ‘on the fly’.

Industry 4.0: Avoiding digitisation and modernisation ‘not an option’

30-Nov-2018 By Ben Hargreaves

If the industry wants to maintain control of manufacturing operations, it has to adopt digital technologies or face being ousted by Amazon, suggested GSK’s Pharma 4.0 director.

Sun Pharma buys Japanese drugmaker with two manufacturing sites

27-Nov-2018 By Flora Southey

Sun Pharma has announced plans to acquire Pola Pharma for $1m, adding topical drug and injectables manufacturing capabilities to its network in Japan.

News in brief

Dr. Reddy’s stock shares rises amid recent US FDA citations

20-Nov-2018 By Maggie Lynch

Dr. Reddy’s Laboratories site in Visakhapatnam, India, was issued a Form 483 last month, yet shares rose after a more recent audit where zero observations were noted.

Pharma Integrates

What will tip the scales towards continuous manufacturing?

20-Nov-2018 By Ben Hargreaves

A closer partnership between CDMOs and pharma companies could share the risk of innovation, suggested one pharma director.

PHARMA INTEGRATES

CDMO partnerships must share risk and balance power, say industry representatives

19-Nov-2018 By Flora Southey

Without a win-win contract in place, innovators will be driven to manufacture in-house, says JM executive.

AAPS PharmSci360

‘The rules of the game’: Applying first principles of engineering to manufacturing

16-Nov-2018 By Maggie Lynch

Bernard McGarvey, formerly of Eli Lilly, spoke with us about first principles of engineering in pharma, following his keynote ‘Engineering First Principles Applications to Pharmaceutical Manufacturing.'

Glenmark expands manufacturing to US in ‘natural choice’ North Carolina

13-Nov-2018 By Flora Southey

India-headquartered Glenmark Pharmaceuticals has opened a 100,000-square-foot facility on the East Coast for the manufacture of fixed dose formulations.

NEWS IN BRIEF

Hovione expands production capacity of oral dosage forms

12-Nov-2018 By Ben Hargreaves

The Portuguese CDMO has announced plans to improve production capacity by bringing in commercial scale equipment for blending, tabletting and coating.

AAPS PharmSci 360: Quotes that carry

09-Nov-2018 By Maggie Lynch

This week in-PharmaTechnologist attended AAPS PharmSci360 in Washington, D.C. where discussions and thought-provoking ideas bounced across sessions – here, we highlight some of the most significant.

Q&A

Final countdown: Industry will be ready to ‘serialize’ in three weeks, says RAPS

08-Nov-2018 By Flora Southey

With less than one month until the US DSCSA deadline, RAPS member Greg Cathcart says the biggest concern for firms is understanding what is required, and when.

Q&A

Big vs small: How CMO Legacy Pharma found the middle ground

05-Nov-2018 By Flora Southey

Legacy Pharmaceuticals says it has deliberately positioned itself as a mid-sized CMO to serve a rapidly changing industry.

Dr. Reddy’s Duvvada site issued Form 483 with 8 observations

01-Nov-2018 By Maggie Lynch

Dr. Reddy’s formulations and manufacturing facility in Duvvada, India, was issued a letter noting eight violations after an audit by the US FDA.

The top 3 challenges to next-gen processing and how the industry is racing forward

30-Oct-2018 By Melissa Fassbender

Nascent next-generation processing technologies are expected to have a significant effect on how drugs are brought to market – faster and more cost-effectively than ever before, says industry expert.

Aspen pumps $231m into South African manufacturing site

30-Oct-2018 By Flora Southey

Aspen will spend a record sum on transforming its Port Elizabeth manufacturing site, marking the ‘single biggest pharmaceutical investment’ in South Africa to date.

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.