Bulk ingredients

Dispatches from ChemOutsourcing

CMO consolidation: Do biopharma partners see any benefits?

17-Sep-2014 By Zachary Brennan

As contract manufacturers continue to consolidate, some in the industry are questioning whether the resulting companies have the ability to offer the same services as the former individual companies. 

Almac teams with Welsh academics to create P450 enzymes for industry

16-Sep-2014 By Gareth Macdonald

Almac has teamed up with Welsh Academics and industrial chemistry firm Hockley International to develop enzymes capable of making drug intermediates more quickly.

Relypsa selects Patheon for finished dose manufacturing of patiromer

15-Sep-2014 By Zachary Brennan

Relypsa has entered into a multi-year commercial manufacturing and supply agreement with CMO Patheon for the finished product manufacture of patiromer, Relypsa's potential treatment of hyperkalemia.  

Arrested: compounding pharmacist linked to 2012 meningitis deaths

09-Sep-2014 By Fiona BARRY

US authorities have arrested Glenn Chin, a supervising pharmacist they say was involved in compounding the contaminated injections behind an outbreak of fungal meningitis that struck 751 patients and killed 64 in 2012.

Dispatches from the NYSE

Catalent sees growth strengthened by international softgel markets

09-Sep-2014 By Zachary Brennan

CDMO (contract development and manufacturing organization) Catalent saw Q4 revenue rise 3% and income rise 66% thanks in part to an increase in its oral technologies segment.

Xellia says it planned to invest in Raleigh plant before new tax deal

04-Sep-2014 By Gareth Macdonald

Xellia has agreed to invest $100m in equipment, retain staff and create 40 full time jobs at the plant it bought in Raleigh, North Carolina in return for business incentives. 

CMO Kentucky Bioprocessing grows Ebola mAb from tobacco

02-Sep-2014 By Fiona BARRY

ZMapp, the experimental Ebola therapy given to a handful of infected patients in West Africa, is being produced in tobacco plants for Mapp Biopharmaceutical by CMO Kentucky Bioprocessing in collaboration with drugmaker Defyrus.

Patheon propels itself into US biologics market in Gallus acquisition

27-Aug-2014 By Dan Stanton

Patheon has acquired Gallus BioPharmaceuticals adding two US biologics plants and says with an industry shift towards medium sized bioreactors it now holds the market advantage.

Recipharm: 'Client investment gives us competitive edge in CDMO space'

26-Aug-2014 By Dan Stanton

Parallel deals to invest in Isofol Medical and manufacture the alternative chemotherapy agent Modufolin on its behalf are evidence of Recipharm’s ambitious growth strategy, the CDMO says.

DEA approves manufacture of GHB at Patheon Cincinnati plant

26-Aug-2014 By Dan Stanton

Patheon has received approval from the DEA to bulk manufacture the schedule I product Gamma Hydroxybutyric Acid (GHB) from its facility in Cincinnati, Ohio.

Catalent contract secure as Roche buys InterMune for $8.3bn

25-Aug-2014 By Dan Stanton

Roche has bought InterMune for $8.3bn (€6.3bn) and says it will continue contracts with Catalent and two API suppliers for the manufacture of its lead product Esbriet (pirfenidone).

Lonza not asked for back taxes following decision to close Hopkinton site

19-Aug-2014 By Gareth Macdonald

Lonza has not been asked to pay back taxes after abandoning plans to expand its biologics plant in Hopkinton, Massachusetts last year.

Recipharm to buy Corvette to drive Italian growth and boost freeze drying clout

19-Aug-2014 By Gareth Macdonald

Recipharm will buy Corvette Pharmaceutical Services Group from private equity owners LBO Italia Investimenti to add much needed lyophilisation capacity and increase access to the Italian market.

UDG exits pre-wholesale JV; nets €70m for packaging and comms businesses

18-Aug-2014 By Dan Stanton

UDG Healthcare has sold its share in a pre-wholesale supply chain JV to partner Alliance Boots and outlined plans to invest some of the €82m ($110m) proceeds in its packaging and marketing businesses.

Small molecule, biologics manufacturing drive WuXi growth in Q2

18-Aug-2014 By Zachary Brennan

With almost 20% year-over-year growth in its manufacturing services, Chinese CRO and CMO WuXi now expects its small molecule manufacturing and biologics to be the key drivers of growth for the next several years, Ge Li, chairman and CEO of WuXi, said.

Recipharm cites sales and earnings hike in acquisition plan

14-Aug-2014 By Gareth Macdonald

Recipharm AB will continue its spending spree of the past few years according to CEO Thomas Eldered, who reiterated the CMO’s plan to grow through takeovers in a results presentation earlier today.

IMCD sees modest gains post IPO and plans to accelerate growth efforts

13-Aug-2014 By Staff reporter

IMCD has seen a modest increase in operating profit and revenue since going public in June according to first half results published earlier today.

CMO issues persist as Cubist announces third recall for potential glass in antibiotic

11-Aug-2014 By Zachary Brennan

For the third time since last August, Cubist Pharmaceuticals has recalled lots of its antibiotic Cubicin injection due to the potential of glass particulates in a manufacturing line produced by an unnamed CMO (contract manufacturing organization).

NIH looks to crowdsource and repurpose older drugs

04-Aug-2014 By Anthony King

This summer, the National Institutes of Health (NIH) announced another funding opportunity for experimental drugs proven safe but sitting on the shelves of pharmaceutical companies.  The NIH-sponsored effort is based on a crowdsourcing strategy to establish...

Strategic partnerships driving consolidation of CDMO industry, says report

24-Jul-2014 By Dan Stanton

Growth of Pharma strategic partnerships with contract development and manufacturing organisations (CDMOs) is driving consolidation, according to an industry report.

Profits and capacity utilisation up at Lonza in H1 thanks to pharma

24-Jul-2014 By Gareth Macdonald

Lonza saw profits and capacity utilisation improve in the first half of 2014 with new pharma and biopharma supply contracts and ongoing restructuring being the key drivers.

Onyx contracted for API R&D and manufacturing by UK cancer charity

23-Jul-2014 By Gareth Macdonald

Onyx Scientific has been contracted to develop and manufacture APIs for clinical trials by charitable group Cancer Research UK.

USFDA approves Novasep facilities for kinase inhibitor contract

23-Jul-2014 By Dan Stanton

Novasep has received the regulatory nod to manufacture a kinase inhibitor new molecular entity (NME) following pre-approval inspections at two facilities in France.

ADHD API sales up, specialty opiates down at Johnson Matthey in Q1

23-Jul-2014 By Gareth Macdonald

Johnson Matthey’s API business had a mixed fiscal Q1 with gains made in ADHD ingredients and bulk opiates being accompanied by a decline in revenue from specialty opiates.

Pamplona CMO bullish about biopharma prospects after fundraising

22-Jul-2014 By Gareth Macdonald

3P Biopharmaceuticals has raised funds and announced plans to invest in its manufacturing capabilities to meet the needs of international clients.

Big Pharma's 'intellectual arrogance' stunts CMO partnerships, says GPCM Chair

22-Jul-2014 By Dan Stanton

Efficient relationships with contract manufacturers are being held back by Big Pharma’s ‘intellectual arrogance’ and ill-defined operational teams, according to an ex-Director at GlaxoSmithKline.

UPDATE

Baxter Q2: Drop in demand hits CMO biz, despite overall sales growth

21-Jul-2014 By Dan Stanton

Baxter BioPharma Solutions dropped four percent year-on-year for the second quarter 2014 due to a fall in demand for contract manufacturing services.

Consultant: For CMO selection, its the (molecule) size that counts!

16-Jul-2014 By Dan Stanton

The complex nature of biopharmaceuticals dictates the choice of contract manufacturer when compared with selecting a partner for small molecule drugs, according to a life sciences consultant.

CMO quality audits: necessary and beneficial to all, says consultant

10-Jul-2014 By Dan Stanton

A quality assurance audit is as beneficial to the CMO as it is to the sponsor selecting a third-party manufacturer, according to an ex-Merck Serono and MHRA consultant.

Russia set for first foreign CMOs as pharma preps for 2020 policy

09-Jul-2014 By Dan Stanton

Several international CMOs will establish themselves in Russia over the next few years as pharma looks to satisfy the country's manufacturing policies, the CEO of R-Pharm predicts.

Xellia bags Fresenius Kabi plant and supply contract

08-Jul-2014 By Gareth Macdonald

Finished dosage form and API manufacturer Xellia has acquired a US plant from Fresenius Kabi in a deal it says enhances supply chain security.

Merck Millipore says Indian lab can boost generics quality

07-Jul-2014 By Fiona Barry

Merck Millipore, the life sciences tools division of Merck KGaA, has launched a solid dose formulation lab in India, its first outside Europe.

Kemwell's oral solid dose plant approved following joint European inspection

07-Jul-2014 By Staff Reporter

An oral solid dose manufacturing plant in Bangalore, India operated by CMO Kemwell Biopharma has passed a customer-prompted audit by European regulators and had its cGMP status renewed for the next three years.

Hospira finally completes Orchid plant acquisition

07-Jul-2014 By Gareth Macdonald

Hospira has paid Orchid Chemicals and Pharmaceuticals $218m (€160m) for an API plant in Aurangabad, India to increase its antibiotics production capacity and cut reliance on external suppliers.

Rechipharm contracted to make lidocaine formulation for IUD-related pain

03-Jul-2014 By Gareth Macdonald

Recipharm AB will manufacture commercial supplies of a topical formulation of the anaesthetic lidocaine called Shact that is soon to be launched by developer Pharmanest AB.

Bulk ingredient prices skyrocket in US as payers clamp down

03-Jul-2014 By Zachary Brennan

Bulk pharmaceutical ingredients increasingly used by compounding pharmacies have seen astronomical price hikes over the past two years and now payers are catching on to the trend and stepping in.

US FDA to set more specific GMP regulations for outsourcing facilities

02-Jul-2014 By Zachary Brennan

Until final regulations are finished, the US FDA has released draft guidance describing the agency’s expectations for outsourcing facilities and the cGMP requirements for them.

Dispatches from BIO 2014

Biotech IPO boom generating more work earlier for CMOs

26-Jun-2014 By Zachary Brennan

The biotech boom of over 165 IPOs in 2013 has resulted in earlier and more lucrative work for CMOs (contract manufacturing organizations), experts say.

Dispatches from BIO 2014

Kalon building $91m vaccine manufacturing facility in Texas for GSK partnership

24-Jun-2014 By Zachary Brennan

Texas-based Kalon Biotherapeutics is in the process of building two new biomanufacturing facilities, including a $91m facility to produce flu vaccines for GlaxoSmithKline. 

Big Pharma Insourcing replacing Asian suppliers as competition for western CMOs

23-Jun-2014 By Dan Stanton

Hidden costs and quality issues have encouraged pharma to abandon China and India, but Western CMOs are now under threat from a return to in-house manufacture, says a procurement consultant

Dispatches from the GPCM Conference, London, UK

For big pharma, ten is the magic number of CMOs says ex-GSK Director

18-Jun-2014 By Dan Stanton

Big pharma is moving towards strategic partnerships with CMOs, according to speakers at the Global Pharmaceutical Contract Manufacturing (GPCM) Conference, with the ideal number of partners being ten.

Public Recipharm plans acquisitions in consolidating CMO sector

17-Jun-2014 By Gareth Macdonald

Recipharm AB has not ruled out battling with Catalent and Patheon in the softgels market and confirmed that acquisitions were the key driver for its decision to go public.

ADC pipelines drive single-use expansion at Lonza's clinical facility

11-Jun-2014 By Dan Stanton

Lonza has invested in single-use technology at its Swiss clinical manufacturing facility citing a rise in demand as customer’s grow their antibody-drug conjugate (ADC) pipelines.

ScinoPharm to manufacture API for TaiGen’s stem cell drug

10-Jun-2014 By Zachary Brennan

ScinoPharm Taiwan on Monday signed a manufacturing and clinical supply contract with TaiGen Biotechnology to provide the API for Burixafor, a potential stem cell treatment. 

EMA reinstates Ranbaxy’s GMP certificate at Toansa site

09-Jun-2014 By Zachary Brennan

European regulatory authorities have reinstated the Good Manufacturing Practice (GMP) certificate at Ranbaxy Laboratories’ API manufacturing site in Toansa, India, which was suspended in January.

Complex manufacturing more likely kept in-house, says J&J post Ben Venue

05-Jun-2014 By Dan Stanton

Outsourcing is still a significant part of Janssen’s strategy, the firm says despite suffering shortages due to manufacturing and quality problems at now defunct CMO Ben Venue.

WuXi up on outsourcing; adds HPAPIs to its offerings

04-Jun-2014 By Dan Stanton

As WuXi talks of a surge in its outsourced manufacturing services, the company has begun offering high-potency active pharmaceutical ingredients (HPAPIs).

AMRI buys commercial manufacturer OsoBio for $110m

03-Jun-2014 By Zachary Brennan

CMO (contract manufacturing organization) AMRI has agreed to acquire Oso Biopharmaceuticals Manufacturing for $110m in cash and thereby expand to late-stage and commercial product manufacturing. 

Hospira to invest $120m in injectable facility in Kansas

02-Jun-2014 By Zachary Brennan

As part of a wave of good news for the beleaguered Hospira, the company said it will inject $120m into its McPherson, Kansas, facility, which will result in 150 new jobs over the next five years.

Hikma eyes Ben Venue's assets as part of $300m Bedford Labs acquistion

29-May-2014 By Dan Stanton

Hikma Pharmaceuticals says it is evaluating Ben Venue’s manufacturing facility as an option in its $300m (€220m) acquisition of Bedford Laboratories.