Contract Manufacturing

Johnson Matthey: Q1 API revenues down on order timings

20-Jul-2016 By Gareth Macdonald

Johnson Matthey said a slight decrease in API sales during the first quarter of its fiscal year was due to the timing of customer orders.

Constipation med linked to 46 B. cepacia cases in US recalled by PharmaTech

19-Jul-2016 By Gareth Macdonald

A constipation medication made by PharmaTech LLC has been recalled after being linked to an outbreak of the bacteria B. cepacia in five US states.

FDA adds 4 API manufacturers to 'Red List'

19-Jul-2016 By Melissa Fassbender

Two Chinese and two Indian companies have been banned from importing APIs to the US – one manufacturer says it’s making GMP compliance a “priority.”

CDMO Vetter to invest $320m in US-based manufacturing facility

13-Jul-2016 By Melissa Fassbender

The new manufacturing facility is the first of its kind to be developed outside of the company’s headquarters in Germany.

Apax: Latest generics takeover Invent Farma will include API division Inke

13-Jul-2016 By Gareth Macdonald

Private equity fund Apax Partners will take control of Spanish API manufacturer Inke when it completes the acquisition of Invent Farma later this year.

Cambrex makes 'Pharma 3' plant operational after equipment delivery delays

13-Jul-2016 By Gareth Macdonald

Cambrex has brought a delayed Iowa API facility online and completed work on a shell plant that can be tailored to specific projects.

Regulatory changes 'defining' serialization processes: key considerations and opportunities

11-Jul-2016 By Melissa Fassbender

With deadlines around the corner, companies are beginning to plan their serialization initiatives – a process defined by regulatory changes, says Antares Vision.

French plant transfers to Vectura Group as Aenova's lease ends

05-Jul-2016 By Dan Stanton

Aenova’s lease of a manufacturing plant in France has ended and the facility has been transferred back to SkyePharma, now part of the Vectura Group.

Charles River acquires analytical CRO

28-Jun-2016 By Melissa Fassbender

Charles River Laboratories has acquired Blue Stream Laboratories, expanding the company’s biologic and biosimilar development capabilities.

Serialisation regulations to impact all corners of pharma, says Recipharm

27-Jun-2016 By Dan Stanton

The pharma industry is underprepared for the upcoming global regulations says Recipharm, which has inked three new tech deals as part of its €40m serialisation effort.

Cobra Biologics and Alligator Bioscience extend partnership

23-Jun-2016 By Melissa Fassbender

Cobra Biologics has been re-contracted by Alligator Bioscience to support cell line development for an immune-oncology antibody.

Juniper invests in tablet technology for UK site

22-Jun-2016 By Gareth Macdonald

Juniper Pharma Services has invested in a tablet press that can produce 42,000 pills an hour citing customers’ clinical trial supply needs as the driver.

Japanese firms form monoclonal antibody manufacturing JV with an eye on biosims

21-Jun-2016 By Gareth Macdonald

Mitsubishi Gas Chemical and Nippon Kayaku have said they will start making monoclonal antibody drugs at a site in Niigata, Japan within two years.

Phalanx Labs banned from shipping APIs to US after refusing inspection

17-Jun-2016 By Gareth Macdonald

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 to buy Spain formulation plant from Roche

15-Jun-2016 By Gareth Macdonald

Famar will buy a Roche solid dose manufacturing facility in Spain in an agreement that will also see it make drugs for the Swiss pharmaceutical giant.

Update

Almac facility successfully passes FDA inspection

14-Jun-2016 By Melissa Fassbender

The global contract development and manufacturing organization (CDMO) announced that its Durham, North Carolina-based facility completed a successful US Food and Drug Administration (FDA) inspection.

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

13-Jun-2016 By Gareth Macdonald

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.

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

09-Jun-2016 By Gareth Macdonald

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

Dispatches from BIO 2016

Brammer Bio opens new cell and gene therapy manufacturing facility

08-Jun-2016 By Melissa Fassbender

The new 50,000 square foot facility in Lexington, MA will be dedicated to late phase development and commercial manufacturing for advanced cell and gene therapies.

Dispatches from BIO 2016

BioDuro launches as CDMO at BIO International

07-Jun-2016 By Melissa Fassbender

The global contract research organization (CRO) announced the formal launch at BIO International, which takes place this week in San Francisco, CA.

CORRECTION - Dispatches from BIO 2016

Merck & Co. and Fujifilm team to share capabilities at new $60m microbial plant

07-Jun-2016 By Dan Stanton

A new $60m facility at a MSD site in Ireland will offer Fujifilm Diosynth customers 20,000L of microbial biologics capacity in a collaboration between the two firms.

CMC Biologics expands GMP manufacturing capacity in Denmark

02-Jun-2016 By Melissa Fassbender

CMC Biologics as upped its production capacity at its Copenhagen facility with plans to have equivalent capacity on both sides of the Atlantic in 2017.

Safety board clears TxCell to restart Ovasave study that was halted last year

27-May-2016 By Gareth Macdonald

TxCell has been cleared to restart a Phase IIb trial of its candidate Crohn’s disease cell therapy by European regulators.

Colorcon to buy BASF's Kollicoat coating system product

25-May-2016 By Gareth Macdonald

Colorcon will buy BASF’s Kollicoat excipient coating system product line in a deal announced today.

Ajinomoto Althea gets US patent for fast, industrial-scale antibody crystallization method

19-May-2016 By Gareth Macdonald

Ajinomoto Althea has been granted a US patent for a whole antibody crystallization method that is faster at producing stable, biologically-active crystals than current techniques.

Biopharma CEOs shifting focus

19-May-2016 By Melissa Fassbender

According to the most recent Biopharma CEO Confidence Index, CEOs are shifting their focus back to their pipelines and have plans to increase outsourcing.

Finished dosage formulations demand driving changes for CMOs

18-May-2016 By Melissa Fassbender

As “one of the fastest growing areas in pharma,” the demand for finished dosage formulations is having an impact on several aspects of the CMO industries.

Fermion invests $33m to add HPAPI capacity at Hanko plant

17-May-2016 By Gareth Macdonald

Fermion will invest €30m ($33m) to expand its API facility in Hanko, Finland to build its high potency drug ingredient manufacturing business.

UK cell and gene therapy capacity hike signals long-term role says CGT

11-May-2016 By Gareth Macdonald

Recent capacity growth means the UK will be a cell and gene therapy hub for years to come according to the authors of a new manufacturing survey.

Almac launches pod for GDP, temperature-controlled shipping

10-May-2016 By Melissa Fassbender

The contract development and manufacturing organization (CDMO) launched its new Almac Pod™ service solution to safeguard customer’s products.

Repligen to expand chromatography column production capacity in US and Europe

10-May-2016 By Dan Stanton

Repligen says it intends to build out a recently acquired German facility to support its European downstream technologies presence.

Biologics CDMO opens new facility in Research Triangle

10-May-2016 By Melissa Fassbender

The BioProcess Innovation Center is a new three-story, 62,000 square foot facility in Research Triangle Park, North Carolina.

AMRI acquires API business, expands into Europe

05-May-2016 By Melissa Fassbender

AMRI has acquired the Italy-based chemical company, Euticals, in a move that expands its API development and manufacturing business.

KaloBios CEO: post-Shkreli 'restart' and 'responsible' drug pricing

03-May-2016 By Melissa Fassbender

As the company tries to move out from under Shkreli's cloud, KaloBios has announced a new product pricing model that promises transparency, affordably, and reasonable return.

Samsung on Samsung: Bioepis selects Biologics as a biosimilars CMO

03-May-2016 By Dan Stanton

Samsung Biologics has been contracted by its joint venture entity Samsung Bioepis to manufacturer biosimilars from its facility in Korea.

Manufacturers concede on price as drug spending increases

02-May-2016 By Melissa Fassbender

Specialty medicine innovation is driving growth, yet advances are being offset by price concessions from manufacturers, according to IMS Health.

Lonza to invest in existing mammalian cell culture facilities after strong Q1

27-Apr-2016 By Gareth Macdonald

Lonza plans to expand mammalian cell culture-based drug and viral manufacturing capacity after growth in both businesses helped it to record first quarter sales.

Controlled substances: fewer CMOs, more regulations

26-Apr-2016 By Melissa Fassbender

The manufacture of controlled substances has faced increased scrutiny over the years, and as such, fewer CMOs are in the market.

Innova Biosciences relocates commercial team and preps for lab expansion

25-Apr-2016 By Gareth Macdonald

Bioconjugation services firm Innova Biosciences has relocated its UK sales and marketing operations citing growing pharmaceutical industry demand.

BARDA talks medical countermeasure manufacturing

25-Apr-2016 By Melissa Fassbender

This year at Interphex, BARDA will discuss various strategies and innovations to reduce drug shortages and improve medicines availability.

PCI Synthesis sets up polymers development lab

20-Apr-2016 By Gareth Macdonald

API manufacturer PCI Synthesis has set up a polymer development group citing growing drug industry demand for advanced coating technologies and excipient technologies.

Evotec has been contracted to manage candidate APIs by Pierre Fabre

19-Apr-2016 By Gareth Macdonald

Evotec has been hired to manage candidate drug compounds by French privately-owned pharmaceutical firm Pierre Fabre.

Famar set to step into North America by buying Quebec plant from Bayer

18-Apr-2016 By Dan Stanton

European CDMO Famar says it will continue making products on behalf of Bayer after acquiring a Canadian manufacturing facility from the firm.

Recipharm to buy Kemwell's API and formulations business for SEK1.7bn

18-Apr-2016 By Gareth Macdonald

Recipharm has agreed to buy Kemwell’s contract development and manufacturing business for a total of SEK1.7bn in two separate deals.

Quotient invests in spray drying tech in response to demand

12-Apr-2016 By Gareth Macdonald

Quotient Clinical has expanded spray drying capacity at its facility in Nottingham, UK citing growing industry interest in solubility enhancement.

Orchid Pharma antibiotic API plant passes US FDA inspection

11-Apr-2016 By Gareth Macdonald

API firm Orchid Pharma has passed a US Food and Drug Administration (FDA) inspection at its facility in Tamil Nadu, India.

Recipharm completes acquisition of majority stake in Nitin Lifesciences

11-Apr-2016 By Gareth Macdonald

Recipharm has completed the acquisition of a majority stake in India’s Nitin Lifesciences in a deal the Swedish contractor says strengthens its presence in an important market.

Aesica adds dev-stage formulation capabilities for potent APIs and controlled drugs

05-Apr-2016 By Staff reporter

Aesica has doubled early formulation development capacity and added controlled drug handling capabilities at its manufacturing facility in Queenborough, UK.

ICIG completes acquisition of Sandoz site

04-Apr-2016 By Melissa Fassbender

International Chemical Investors Group (ICIG) has completed its acquisition of Sandoz Industrial Products GmbH from Novartis Group.

Catalent: Limited production begins at suspended French softgel plant

04-Apr-2016 By Dan Stanton

Catalent has missed its forecast for bringing a suspended softgel facility back online, but says production of essential drugs has begun at the French plant.

Product Innovations

Generic method approach for determination of residual solvents in active pharmaceutical ingredients by gas chromatography

Solvents are defined as organic chemicals that are used to dissolve components. They are used during the manufacture of drug substances and can also potentially...

Pulmonary Delivery of Orally Inhaled Therapeutics

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Addressing Challenges with Clinical In-Use Testing

Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Léa shares her expertise and describes...

Outsourcing-Pharma

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