Processing equipment

Latest GMP crackdown leaving ‘naive’ cosmetic firms with FDA warnings

06-Mar-2018 By Dan Stanton

Increased enforcement of cGMP on over-the-counter (OTC) drugs is highlighting the grey-area in classification with cosmetic products, a former FDA director says.

Aurobindo injectables plant receives Form 483 with nine observations

05-Mar-2018 By Dan Stanton

The US FDA has issued a Form 483 to a manufacturing plant in Hyderabad, India but Aurobindo says none of the observations relate to data integrity.

The Beast from the East takes on Ireland: Takeda and Jazz temporarily shut sites

01-Mar-2018 By Flora Southey

A clash between Storm Emma and Arctic temperatures over Ireland has forced the closure of two Takeda sites in Dublin, and Jazz Pharmaceuticals’ Athlone facility.

WuXi STA to make oligonucleotides for Regulus

01-Mar-2018 By Staff Reporter

Regulus Therapeutics has entered into an oligonucleotide synthesis collaboration with STA Pharmaceuticals for research and mid-scale non-GMP/cGMP manufacturing.

AkzoNobel targets peptide makers with expanded Kromasil offering

28-Feb-2018 By Flora Southey

AkzoNobel Specialty Chemicals has boosted its Kromasil capacity, used to facilitate the separation of compounds in drug development.

AMRI expanding testing services in EU as European client base grows

28-Feb-2018 By Melissa Fassbender

AMRI is expanding its container closure integrity testing (CCIT) services in the European Union (EU), with further services to be added later in 2018.

Fujifilm building $37m facility to support liposome drugs

27-Feb-2018 By Dan Stanton

Toyama Chemical’s facility will support trials of lipsome drugs produced using technologies cultured through Fujifilm’s photographic film business.

Pfizer’s McPherson site: Recalls and repeat observations

26-Feb-2018 By Flora Southey & Dan Stanton

The detection of cracks of the surface of glass vials has prompted a voluntary recall of Labetalol Hydrochloride Injection made at Pfizer’s troubled McPherson, Kansas facility.

Lonza ups HPAPI encapsulation capacity in Florida

22-Feb-2018 By Staff Reporter

Lonza has increased its encapsulation capacity and invested in highly potent active pharmaceutical ingredient (HPAPI) services at a facility in Tampa, Florida.

West Pharma to merge manufacturing and exit sites in network shake-up

21-Feb-2018 By Flora Southey

A network reshuffle will see West Pharma consolidate manufacturing and close some facilities to “streamline” its plant network.

Biocon says FDA 483 at Malaysian plant not due to non-compliance

21-Feb-2018 By Dan Stanton

A US FDA pre-approval inspection of Biocon’s insulin manufacturing facility in Malaysia has resulted in a Form 483 with six observations.

USV receives FDA close-out at Indian plant

20-Feb-2018 By Staff Reporter

The US FDA has lifted a warning at an Indian oral solid dose manufacturing facility run by USV Private Limited.

ImmunoGen closing MA plant: 20 jobs to go, $20m in savings

15-Feb-2018 By Staff Reporter

ImmunoGen says it is shifting drug conjugate manufacturing and quality testing to an outsourcing model and will close its Norwood facility.

Generics, mergers and Teva’s woes: Agilent talks pharma opportunities

15-Feb-2018 By Dan Stanton

Agilent Technologies says changes in the industry this year will present opportunities for continued growth in its pharma processing equipment and consumables business.

Remediation and modernisation plans: Bayer responds to FDA warning

14-Feb-2018 By Dan Stanton

Bayer expects some temporary supply limitations affecting its mature product portfolio as it addresses GMP issues raised in a US FDA warning.

MSD repurposing dormant Irish site and hiring 350 to support Keytruda

14-Feb-2018 By Dan Stanton

Merck Sharp & Dohme (MSD) plans to build a biologics facility at a former small molecule manufacturing site in Swords, Ireland, which it closed last year.

US FDA slams Bayer for ‘inadequate cleaning' and 'discarded records’

13-Feb-2018 By Dan Stanton

Bayer has received a US FDA warning letter at its finished pharmaceutical facility in Leverkusen, Germany.

Site closure, staff cuts: Arbutus reshuffles in Vancouver

13-Feb-2018 By Flora Southey

Arbutus Biopharma Corporation is cutting operations but says it remains committed to developing its messenger RNA drug delivery technology.

Novo Nordisk: Demand drives another equipment boost in Clayton, US

07-Feb-2018 By Flora Southey

Novo Nordisk is planning a $65m (€53m) production capacity expansion at its finished product site in North Carolina, to meet demand for diabetes and obesity medicines.

Nordic project takes ‘manufacturing-on-demand’ approach to future drugs

07-Feb-2018 By Dan Stanton

Nordic Universities will investigate 3D printing, electrospraying, and microfluidics in an industry supported collaboration aimed at revolutionising production in an age of personalised medicine.

AstraZeneca aims for ZS Pharma kidney drug approvals in H1 2018

06-Feb-2018 By Dan Stanton

AstraZeneca says its hyperkalaemia candidate ZS-9 is back on track for approval after manufacturing issues at its Texas facility resulted in regulatory delays.

IDA Ireland says Alkermes job cuts ‘regrettable but understandable’

06-Feb-2018 By Flora Southey

A portfolio shake-up will result in staff lay-offs at Alkermes’ manufacturing facility in Ireland, says the firm.

Celltrion slammed with US FDA warning at biosimilar site

02-Feb-2018 By Dan Stanton

Celltrion says supply of Pfizer’s Inflectra is secure, despite receiving a US FDA warning letter at its biosimilar production plant in Korea.

Marchesini Group invests in serialisation software and 3D printing

01-Feb-2018 By Dan Stanton

Pharma packaging firm Marchesini Group has acquired 48% of its serialisation software partner SEA Vision and forged a long-term agreement worth €125m.

FDA upgrades Kansas plant but Hospira’s legacy continues to haunt Pfizer

31-Jan-2018 By Dan Stanton

The US FDA has upgraded the status of Pfizer’s McPherson manufacturing, hit with a warning letter last year.

Intas puts the fizz back into ex-Sanofi plant with generic effervescents

31-Jan-2018 By Flora Southey

Intas Pharmaceuticals says it ‘worked hard’ over two years to bring an ex-Sanofi manufacturing facility back into production in Newcastle, UK.

Hovione adds inhalation product development tech at former Generis site

30-Jan-2018 By Staff Reporter

Hovione has bolstered its encapsulation for inhaled products technology capabilities at its site in Portugal.

Amneal expands NY site ahead of Impax merger

30-Jan-2018 By Flora Southey

Amneal Pharmaceuticals expects to bring production of some Impax Laboratories’ drugs in-house through a 100,000 sq. ft. expansion at its site in New York state.

Meissner expands aseptic fill/finish range through PDC acquisition

18-Jan-2018 By Staff Reporter

Meissner Filtration Products has bolstered its automated filling offerings through the acquisition of PDC Aseptic Filling Systems.

Telix sets up subsidiary to make and trial radio-labelled meds in Japan

17-Jan-2018 By Gareth Macdonald

Radiopharmaceuticals firm Telix Pharmaceuticals Limited has established a subsidiary in Japan to support clinical development and manufacturing activities.

Eisai ups capacity for Alzheimer’s disease pills and PPIs in China

11-Jan-2018 By Gareth Macdonald

Eisai Co Ltd has completed construction of an oral solid dose form manufacturing facility in Suzhou, China.

Aslan to make Array's small molecule cancer drug varlitinib under new licensing deal

08-Jan-2018 By Gareth Macdonald

Aslan Pharmaceuticals Pte Ltd has licensed manufacturing and sales rights to Array BioPharma’s candidate small molecule pan-HER inhibitor varlitinib.

MilliporeSigma and bluebird bio ink multi-year viral vector deal

03-Jan-2018 By Flora Southey

Bluebird Bio has hired MilliporeSigma to supply lentiviral vectors for the development of gene therapies.

Recipharm to pay INR2.8bn for remaining stake in injectables firm Nitin Lifesciences

02-Jan-2018 By Gareth Macdonald

Recipham has agreed to pay the founders of Nitin Lifescience Limited INR2.8bn ($44m) for the remaining 26% stake they own in the India-based drug manufacturer.

News in brief

Colorcon and Applied DNA Sciences sign tech MOU

20-Dec-2017 By Staff reporter

Colorcon Inc. and Applied DNA Sciences Inc. have teamed up to commercialize an on-dose traceability platform they say will help combat counterfeits.

TxCell set to transfer production process for candidate organ rejection cell therapy to CMO

19-Dec-2017 By Gareth Macdonald

TxCell SA has developed the production process for it range of CAR-Treg based therapies and is preparing to transfer it to its CMO ahead of first-in-human trials.

3D-printing on trend: Aprecia and Cycle sign orphan drug deal

14-Dec-2017 By Flora Southey

Three-dimensional printing technology is attracting increased attention from the US FDA say Aprecia and Cycle, which have announced a partnership to develop 3D-printed orphan drugs.

US FDA looks to answer industry's 3D printed drug concerns

12-Dec-2017 By Dan Stanton

3D printing offers “a tantalizing step toward changing the manufacturing processes” for personalised medicines says a US FDA scientist.

Tjoapack ups bottling capacity to feed pharma's packaging needs

05-Dec-2017 By Dan Stanton

Tjoapack has tripled its bottle packing capacity as increased legislative complexity, ageing populations and pricing pressures drive demand for outsourced packaging solutions.

News in Brief

US FDA inspection lands Glenmark with 483 with seven observations

28-Nov-2017 By Dan Stanton

Glenmark has received a US FDA Form 483 with seven observations at its Baddi finished formulations facility in Baddi, India.

Serial pursuit: Second phase of US track and trace rules begins today

27-Nov-2017 By Dan Stanton

Recipharm says three more of its facilities are equipped and ready for US Drug Supply Chain Security Act (DSCSA) serialisation demands, the deadline for which passes today.

Chinese API plant slammed by US FDA and placed on import alert

27-Nov-2017 By Dan Stanton

The US FDA has issued API manufacturer Hubei Danjiangkou Danao Pharmaceutical a warning citing failures in its quality control unit.

Fresenius Kabi investing $100m and adding 445 jobs in North Carolina

22-Nov-2017 By Dan Stanton

Encouraged by a North Carolina state grant, Fresenius Kabi will expand its prefilled syringes business acquired from Becton, Dickinson and Company in 2016.

Oregon drugmaker feels heat as FDA says to get out the kitchen

21-Nov-2017 By Dan Stanton

The US FDA has slammed Ridge Properties for making drug products using “kitchen utensils and cookware” in a warning letter sent last month.

AbbVie claims strike did not stop operations at Irish plant

15-Nov-2017 By Dan Stanton

Trade union members picketed AbbVie’s bulk tablet facility in Cork yesterday but the firm says operations and supply have not been disrupted.

Recipharm cutting Swedish manufacturing but ‘unlikely’ to sell facilities

13-Nov-2017 By Flora Southey

Recipharm says it will cease manufacturing at sites in Stockholm and Höganäs, citing ‘underperforming operations’ at its package filling and manufacturing-focused sites.

Codexis expects ‘significant revenue’ from Nestlé collaboration

13-Nov-2017 By Dan Stanton

The recently inked development partnership with Nestlé Health Science could net Codexis upwards of $350m.

UPDATE

IMA Life inks Atonarp’s freeze-drying tech

09-Nov-2017 By Flora Southey

IMA Life is boosting its freeze-drying (lyophilisation) and aseptic processing services with Atonarp’s miniaturised mass spectrometry technology.

Lupin receives US FDA warnings at two Indian manufacturing plants

08-Nov-2017 By Dan Stanton

Indian drugmaker Lupin says product supply will not be disrupted at plants in Goa and Indore hit with a combined US FDA warning letter.

Mutual recognition: US to accept GMP inspections from eight EU regulators

02-Nov-2017 By Dan Stanton

The US FDA says the recognition of facility inspections from eight European regulatory authorities is an “unprecedented and significant step forward” in the transatlantic Mutual Recognition Agreement.