Bulk ingredients

Shangpharma plans to merge API and research units and list in China

04-Apr-2017 By Gareth Macdonald

Shangpharma plans to merge its API unit with its research arm as Shanghai Chempartner, which it will list on the Shanghai or Shenzhen stock exchange.

China proposes changes to drug trial and API importation laws

03-Apr-2017 By Gareth Macdonald

Chinese regulators have proposed changes to rules covering clinical trials, API importation and drug approval in a bid to improve access to medicines.

Avista completes $4m facility expansion at former Microtest Labs

27-Mar-2017 By Melissa Fassbender

The expanded facility features an additional 4,200 square feet of space to enhance its microbiology, sterility testing, and microbial ID service offerings.

Divi's Labs' Vizag plant banned from shipping to US

23-Mar-2017 By Gareth Macdonald

Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the US.

update with comment from FDA

US FDA criticizes Indian drug firm USV for problems at multiple sites

22-Mar-2017 By Gareth Macdonald

The US FDA has called on Indian drug firm USV Private Limited to rethink how its tests for microbial contamination at its manufacturing facilities.

Nicox resubmits AC-170 NDA after API supplier resolves GMP issues

09-Mar-2017 By Gareth Macdonald

Nicox S.A. has resubmitted AC-170, its conjunctivitis associated itching drug candidate, for US FDA review after its API supplier resolved the problems that saw the agency reject the New Drug Application (NDA) last year.

CRO-less trial of malaria generic uses crowdfunding to treat bowel cancer

08-Mar-2017 By Dani Bancroft

In the absence of a CRO, the 200 patient NeoART study is relying on the UK NHS, crowdfunding and charity to trial an antimalarial generic for late stage bowel cancer.

Mithra CDMO signs up a second Estrogen drug in 20-year Fuji deal

06-Mar-2017 By Dani Bancroft

Mithra CDMO has entered a second agreement for Fuji Pharma to commercialise Donesta in Asia, another of Mithra’s estrogen-based hormone drugs.

PEOPLE ON THE MOVE

Outsourcing-Pharma's Hiring and Firing Roundup February '17

28-Feb-2017 By Dani Bancroft

Outsourcing-Pharma presents this month's roundup of who is moving where in the contract research and manufacturing industry.

Granules to expand Indian API plants and US dosage form site

21-Feb-2017 By Gareth Macdonald

Granules India will build an API production facility in Bonthapally, Telangana and expand other manufacturing sites in a project backed by the Word Bank.

Chinese CDMO group buys New Jersey J-STAR for $26m

02-Feb-2017 By Dani Bancroft

A US-subsidiary of the Chinese CDMO Porton Fine Chemicals Ltd. has bought the New Jersey based small molecule API contract research organisation, J-STAR Research, Inc.

Canadian Lupus drug to enter Phase III with Worldwide Clinical Trials

30-Jan-2017 By Dani Bancroft

Aurinia Pharmaceuticals Inc. will use the CRO Worldwide Clinical Trials’ services for its Phase III trial for Lupus nephritis.

Q&A with CEO and CMO

Medical marijuana chewing gum to treat IBS in Dutch trial

18-Jan-2017 By Dani Bancroft

AXIM Biotechnologies, Inc. will start 40-person clinical trial in the Netherlands for a mint-flavoured medical marijuana chewing gum to treat Irritable bowel syndrome (IBS).

CMO Evonik acquires silica business for $630m

13-Dec-2016 By Melissa Fassbender

Evonik Industries AG has acquired the silica business from the US company J.M. Huber, expanding the company’s presence in North America and Asia.

Lonza to sell therapeutic peptides business to PolyPeptide

07-Dec-2016 By Gareth Macdonald

Lonza has agreed to sell its therapeutic peptide business to PolyPeptide Laboratories in a deal that will also see the latter firm take on 280 staff.

Compounding issues: gov’t watchdog releases drug compounding report

28-Nov-2016 By Melissa Fassbender

The FDA is still in “the early stages” of overseeing 503B outsourcing facilities, but efforts continue as concerns surround the oversight of drug compounders, according to a recent report by the US Government Accountability Office (GAO).

Almac expands capabilities to meet pediatric formulations demand

23-Nov-2016 By Melissa Fassbender

The acquisition of a stick sachet packaging line from Merz expands Almac Group’s MHRA/FDA-approved UK commercial packaging facility to meet the growing demand for specialist packing solutions.

Both small and large CMOs to benefit from pharma capacity and agility demands

21-Nov-2016 By Dan Stanton

Larger CMOs are likely to be better for commercial manufacturing but small players offer niche services and agility for lower volumes, say Symbiosis and Idifarma.

CordenPharma completes API process bay for category 4 compounds

19-Oct-2016 By Melissa Fassbender

This week CordenPharma announced the completion of its new highly potent API process bay for category 4 compounds.

Cambrex investment continues as industry trends ‘remain favorable’

07-Sep-2016 By Melissa Fassbender

The latest in a series of investments, Cambrex has recently expanded its Sweden-based site as part of its ongoing investment in small molecule API manufacturing across its global network of facilities.

More Cambrex capacity expansion: API firm to grow Karlskoga facility

07-Sep-2016 By Gareth Macdonald

Cambrex will spend $9m (€8m) to add large-scale manufacturing capability at its API production facility in Karlskoga, Sweden.

BASF API biz boosts Siegfried in H1, but IT integration costs hit profits

22-Aug-2016 By Gareth Macdonald

Siegfried Holding AG has attributed a surge in API sales to the drug ingredients business it bought from BASF last year, but says that integration costs hurt profits.

WuXi AppTec subsidiary passes third US FDA inspection

15-Aug-2016 By Melissa Fassbender

WuXi AppTec has announced that its Jinshan Shanghai-based small molecule active pharmaceutical ingredient (API) and advanced intermediate manufacturing facility has passed its third US FDA inspection.

CRO Velesco Pharma adds compound management services

03-Aug-2016 By Melissa Fassbender

The contract research organization (CRO) Velesco Pharma has opened a new laboratory in its Plymouth, MI-based facility to support an increased demand for materials management.

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Cambrex predicts flat generic API sales for 2016

Cambrex to start work on Pharma 4 API site in 2016

28-Jul-2016 By Gareth Macdonald

Cambrex has said it will invest around $20m in its Pharma 4 API facility before the end of the year in an effort to get ahead of the capacity utilisation curve.

BASF reports lower demand for remaining APIs in Q2

27-Jul-2016 By Gareth Macdonald

BASF has said it saw lower demand for its remaining active pharmaceutical ingredients (APIs) in the second quarter.

Patheon will list on NYSE today

21-Jul-2016 By Gareth Macdonald

API and drug maker Patheon will begin trading on the New York Stock Exchange under the symbol PTHN later today.

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.

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.”

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.

AMRI completes €315m Euticals takeover to add capacity to API business

12-Jul-2016 By Gareth Macdonald

AMRI has completed the acquisition of Italian API firm Euticals for €315m ($350m).

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.

Indian drug advisory board backs proposed API import license fee hike

16-Jun-2016 By Gareth Macdonald

A plan to charge drug firms more to import APIs into India has won the support of the Government’s Drugs Technical Advisory Board (DTAB).

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.

updated

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