APIs (active pharmaceutical ingredients)

US FDA notes ‘disturbing lack of oversight’ over valsartan contamination

12-Dec-2018 By Ben Hargreaves

Zhejiang Huahai received a warning letter from the US FDA, which observed that it ignored two separate customer complaints about contamination.

Simpler drug delivery through capsule-based inhalation

10-Dec-2018 By Ben Hargreaves

Delivery by inhalation could be an easier way to deliver therapies in areas such as oncology, suggested ACG’s development manager.

US FDA notes 22 observations at Lupin’s Indian base

06-Dec-2018 By Ben Hargreaves

Lupin has received 22 observations across three facilities at its Mandideep campus, which the company says are only ‘procedural in nature’.

Mylan expands valsartan recall in US

05-Dec-2018 By Flora Southey

Mylan has requested all lots of valsartan, as well as combination amlodipine/valsartan, and valsartan/ hydrochlorothiazide tablets, be returned in the US.

GSK rebuilds oncology pipeline with $5.1bn acquisition

04-Dec-2018 By Maggie Lynch

GSK entered an agreement with Tesaro to gain ‘under-appreciated’ PARP inhibitor assets and a Boston base.

Five further countries join EMA-FDA mutual recognition pact

03-Dec-2018 By Ben Hargreaves

Inspections of manufacturing facilities undertaken by Belgium, Denmark, Finland, Latvia and Estonia will be recognised as valid by the US FDA.

‘Colour is crucial’: Capsule choice more than a brand statement

03-Dec-2018 By Ben Hargreaves

The colour of a capsule can play an important role in the safety of a product and provide consumers with intuitive information for dosage, according to Nicolas Madit of Lonza.

WuXi STA aims to ‘add one API plant every year’, says VP

03-Dec-2018 By Ben Hargreaves

STA Pharmaceutical sees building out its own manufacturing infrastructure as a stronger growth plan compared to pursuing acquisitions.

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.

Aquestive receives CRL, switches API supplier over concerning ‘quality controls’

29-Nov-2018 By Ben Hargreaves

Aquestive’s NDA to the US FDA was knocked back over API issues, but the company still expects the product to be available by 2020.

GW: Inventory and capacity set for ‘even the most aggressive of demand forecast’

28-Nov-2018 By Flora Southey

GW Pharma has told investors its capacity is “more than sufficient” to meet launch requirements in Europe next year, where the firm’s CBD medicine Epidiolex is under review.

Mylan NDEA contamination prompts Teva recall in US

28-Nov-2018 By Flora Southey

Teva is the latest firm to recall valsartan products after a probable carcinogen was detected in its supplier’s API.

Casi to create ‘key asset’ manufacturing facility in China

26-Nov-2018 By Ben Hargreaves

The US company will complete a ‘large-scale’ manufacturing facility to support production in the next three to five years.

Pharma Integrates

Five technologies that could disrupt pharma manufacturing

23-Nov-2018 By Ben Hargreaves

Pharma production is ‘too conservative’ and needs to ‘be bolder’ in adopting nascent technologies, or be left behind by new models, suggested one MD.

Cambrex acquires Avista for $252m, becomes integrated CDMO

21-Nov-2018 By Maggie Lynch

Cambrex is set to acquire Avista and enter the market of early stage small molecule development and testing.

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.

Europe suspends use of Mylan’s Hyderabad-made valsartan

20-Nov-2018 By Flora Southey

EU authorities have detected NDEA in some batches of Mylan’s valsartan, manufactured in Hyderabad, India.

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.

AbbVie allows generic manufacture of HCV treatment in 99 countries

19-Nov-2018 By Ben Hargreaves

A licensing agreement with MPP will allow access to Mavyret in a number of low- and middle-income countries and territories at ‘affordable prices’.

Q&A: mRNA’s place in vaccine manufacturing with CureVac

19-Nov-2018 By Maggie Lynch

Messenger RNA is demonstrating success in vaccine manufacturing and CureVac is giving it the place to do so with the development of a prophylactic vaccine with mRNA at its core.

NEWS IN BRIEF

Ardena: M&A growth fuels HQ expansion

14-Nov-2018 By Flora Southey

CDMO Ardena has moved into larger headquarters in Gent, Belgium, to “free up space for additional laboratories”, says CEO.

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.

Novartis recalls NDEA-contaminated tablets in US

12-Nov-2018 By Flora Southey

Sandoz is the latest Zhejiang Huahai Pharmaceutical customer to issue a nationwide recall after trace amounts of a probable carcinogen were found in the supplier’s API.

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.

Public-private engage on climate change, same needs to happen for AMR, says DSM

12-Nov-2018 By Ben Hargreaves

Antimicrobial resistance is a global public health threat that both public and private organisations are struggling to combat.

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.

US FDA hits Akorn with second Form 483 this year

08-Nov-2018 By Ben Hargreaves

Akorn’s Somerset facility becomes it second to require remediation action, following the issuance of a US Form 483.

Cystic fibrosis therapy that improves cell function granted EU approval

07-Nov-2018 By Maggie Lynch

Vertex was granted marketing authorization for its cystic fibrosis therapy in a combination regimen, marking the company’s third treatment for the condition to reach the market.

GW Pharma launches Epidiolex in US, awaits EU decision

07-Nov-2018 By Flora Southey

The first US FDA-approved medicine made from the cannabis plant is now available by prescription, at an average yearly list price of $32,500.

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.

Pfizer lowers guidance due to Hospira manufacturing issues

01-Nov-2018 By Ben Hargreaves

Pfizer has updated its 2018 financial guidance due to ‘lower-than-anticipated’ Essential Health revenue.

UPDATE FROM SCIEGEN

ScieGen recall: US FDA finds NDEA impurity in first non-valsartan drug

31-Oct-2018 By Flora Southey

ScieGen Pharmaceuticals has recalled certain batches of hypertension drug irbesartan, after a probable carcinogen was detected in supplier Aurobindo’s API.

SPI Pharma promises ‘fewer failures and higher yield’ with Mannogem XL

30-Oct-2018 By Ben Hargreaves

SPI Pharma has launched Mannogem XL mannitol for the production of various forms of tablets, which the firm says enhances productivity compared to compendial mannitol.

Noramco welcomes ‘new era’ of ultra-pure synthetic cannabinoids

30-Oct-2018 By Flora Southey

The API maker says there are significant advantages to synthetic cannabinoid production from a quality perspective.

‘Magic mushroom’ drug receives breakthrough therapy designation

26-Oct-2018 By Maggie Lynch

Compass Pathways’ psilocybin therapy for treatment-resistant depression has received a breakthrough status to accelerate development – at a time when the incidence of mental illness is rapidly increasing.

US FDA approves first enzyme-blocking antiviral in 20 years

25-Oct-2018 By Maggie Lynch

The US FDA approved Xofluza for the treatment of acute uncomplicated influenza, the first antiviral flu treatment to be approved in almost 20 years.

Recipharm performs ‘unexpected’ U-turn on Höganäs facility

24-Oct-2018 By Ben Hargreaves

Recipharm has reversed its decision about its Sweden-based operations after new customers emerged making the site viable again.

GSK boosts API manufacturing with £54m facility in Scotland

24-Oct-2018 By Flora Southey

GSK has opened a manufacturing plant in Montrose, Scotland, where the firm will make APIs for its Ellipta respiratory medicines.

Novartis spends $2.1bn on candidate with blockbuster potential

23-Oct-2018 By Maggie Lynch

Novartis will acquire Endocyte for $2.1bn, with the core of the deal centering on the latter’s experimental therapy for prostate cancer.

CPhI Worldwide

Brexit only a UK concern? Think again, says NSF director

19-Oct-2018 By Ben Hargreaves

As negotiations continue and discussions on ‘hard Brexit’ outcomes build, few have considered the impact on European industry, one organisation suggests.

GMP deficiency at contractor site lands Acacia Pharma CRL

17-Oct-2018 By Flora Southey

Acacia Pharma remains committed to its API manufacturer and expects to launch lead candidate, Barhemsys, in the first half of 2019, says CEO.

EMA places Zhejiang Huahai under ‘increased supervision’ over quality issues

17-Oct-2018 By Ben Hargreaves

The EMA has placed Zhejiang Huahai under supervision, after the firm produced valsartan medication contaminated by probable carcinogens.

Axim Biotech ‘closes GMP circle’ with manufacturing license for cannabinoids

16-Oct-2018 By Flora Southey

The Dutch Ministry of Health has granted Axim Biotech a manufacturing license to produce cannabis-derived candidates for clinical trials.

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.

Ajinomoto announces 10% price increase on amino acid portfolio

15-Oct-2018 By Maggie Lynch

Ajinomoto’s amino acid technologies division announced a 10% price increase across all of its markets due to rising costs of manufacturing and transportation.

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

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.

Nanonisation can ‘bring back to life’ troublesome assets, says Nanoform CEO

09-Oct-2018 By Ben Hargreaves

Nanoform specialises in producing APIs in a nanoparticle size range, which the company claims can significantly improve bioavailability and potentially change the fate of an asset in the clinic.

GSK to ‘phase out’ manufacture of active ingredients at UK plant, 200 jobs cut

08-Oct-2018 By Ben Hargreaves

Following a review of its Ulverston site, GSK announced at the end of last week it would shed positions related to the manufacture of active ingredients for sterile injections.