Excipients, raw materials and intermediates

UK gov’t guidance leaving too little time to adjust to ‘no deal’ Brexit?

10-Sep-2018 By Ben Hargreaves

IPT speaks to life sciences lawyer, Jane Summerfield, to interpret the recent guidance from the UK government in the event of a ‘no deal’ Brexit.

US FDA issues an alert on life-threatening porcine therapy API

07-Sep-2018 By Maggie Lynch

The FDA issued an alert that Sichuan Friendly Pharmaceuticals has recalled its porcine thyroid API.

Researchers target rapid changes to downstream continuous manufacturing

29-May-2018 By Nick Taylor

Academic research underpins many of the early success stories in continuous manufacturing. Now, Blair Brettmann and her team are working to write another chapter by applying electrospinning and other techniques to downstream processing.

INTERPHEX 2018

Excipient makers want to be the ‘first second’ in novel ingredient development, say execs

17-May-2018 By Flora Southey

An improved relationship between drugmakers and excipient suppliers could help drive development in the novel inactive ingredient sector, says industry expert.

Ardena continues M&A strategy with CMO buy

14-May-2018 By Flora Southey

CDMO Ardena has added drug product capabilities with the purchase of active pharmaceutical ingredient and excipient-focused Syntagon.

News in Brief

Suven passes US FDA inspection, secures CNS product patents

09-May-2018 By Melissa Fassbender

Suven Life Sciences has completed a US FDA renewal inspection at its Pashamylaram-based facility, which manufactures and supplies APIs, intermediates, and formulations.

Codexis outfits CDMO with biocatalyst tech in new partnership model

03-May-2018 By Melissa Fassbender

Codexis is setting up Porton Pharma Solutions with its biocatalyst technology as part of a strategic collaboration aimed at liberating potential cost reductions of up to 20%, says CEO.

Chinese API maker hit with second US FDA warning in three years

03-May-2018 By Flora Southey

The US FDA has issued Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. a warning letter, in which it says the API maker admitted to deleting test data by accident.

Stellar ups aquaculture on demand for limpet protein used in vaccine production

11-Apr-2018 By Dan Stanton

Demand for a protein produced from a marine mollusk used as a carrier molecule in therapeutic vaccines has driven Stellar Biotech to expand a facility in LA.

Hanmi invests in ‘smart plant’ to boost CDMO biz

29-Mar-2018 By Staff Reporter

South Korean firm Hanmi Pharmaceutical has invested 150bn won ($140.7m) in a manufacturing ‘smart plant’ to increase its contract services.

Johnson Matthey sends catalysts to Japan under DKSH deal

28-Mar-2018 By Flora Southey

Johnson Matthey will extend its catalysts services to Japan, under a distribution agreement signed with DKSH.

Double US FDA audit for Granules India ends with one observation

26-Mar-2018 By Staff Reporter

Granules India has received a US FDA Form 483 with one observation at a Telangana API and finished formulation facility.

IPEC and PDA team on excipient risk assessment guidance

22-Mar-2018 By Dan Stanton

IPEC Federation and PDA will publish a technical report in 2019 to provide drugmakers guidelines on how to implement risk assessment challenges of excipient supply.

Noramco signs AMPAC to top up API and intermediates supply

21-Mar-2018 By Flora Southey

AMPAC Fine Chemicals will boost Noramco Inc.’s supply of active pharmaceutical ingredients and intermediates to make abuse prevention and attention deficit disorder treatments, and cannabinoids.

News in Brief

Clariant raising colouring costs

12-Mar-2018 By Staff Reporter

Clariant will raise the prices across its Masterbatch range by up to 7% from April.

No chewing, grinding or snorting: Recipharm adds Altus anti-abuse tech

06-Mar-2018 By Dan Stanton

A license agreement will allow Recipharm to offer its customers Altus Formulation’s INTELLITAB and FLEXITAB anti-abuse drug delivery technologies.

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.

US FDA’s co-crystal final guidance to reduce cGMP burden

15-Feb-2018 By Flora Southey

In response to stakeholder feedback, the US FDA has issued a final guidance detailing changes to the regulatory classification of co-crystals, from intermediate to API.

Sun Pharma hit with another fire at an Indian plant

13-Feb-2018 By Staff Reporter

Sun Pharma says there was no direct loss of production at its Gujarat active pharmaceutical ingredient (API) facility following a fire last week.

Danish regulators slam Indian API maker for GMP failings

05-Feb-2018 By Staff Reporter

Kadam Exports Private has received a statement of non-compliance with GMP after the Danish Medicines Agency found manufacturing deficiencies at its facility in Gujarat.

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.

‘Ostracized and criticized’ Indian CRO hits US FDA with $50m lawsuit

29-Jan-2018 By Dan Stanton

Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns.

Environmental tax will impact firms that use China-made drug intermediates say experts

22-Jan-2018 By Gareth Macdonald

China’s environmental tax will mean higher costs for drug and API firms that rely on intermediates made in the country say industry experts.

Phyton to build contracting business beyond fermentation-based API production

04-Jan-2018 By Gareth Macdonald

Phyton Biotech has said it will further develop its contract manufacturing business under the leadership of new president, Colin Marr.

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.

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.

IPEC rolls out guide to reflect changing pharma excipient landscape

20-Nov-2017 By Dan Stanton

The International Pharmaceutical Excipient Council (IPEC) has updated its Quality Agreement guidelines to reflect changing regulatory expectations and global nature of supply chains.

DowDuPont completes FMC acquisition, bolsters excipient biz

07-Nov-2017 By Dan Stanton

The acquisition of FMC Corporation's health and nutrition business gives DowDuPont “one of the broadest pharma offerings to serve the growing excipients industry,” the firm says.

Intermediates the answer to China API dependence, says Indian export delegate

06-Nov-2017 By Flora Southey

Revising India’s intermediates manufacturing sector will reduce its dependence on China for APIs, says Pharmexcil delegate.

CPHI WORLDWIDE 2017

Continuous manufacturing: suitable excipients & more knowledge required, says Dow

25-Oct-2017 By Flora Southey

Drug firms need excipients suited to continuous manufacturing according to Dow, which says a better understanding of how products perform when used in round-the-clock production is required.

Asymchem says TGA OKed API plant; forecasts 25-35% profit growth in FY 2017

25-Oct-2017 By Gareth Macdonald

Australian regulators have confirmed that Asymchem Laboratories Tianjin Co Ltd’s API plant in Dunhua, China is up to code.

Ex-Hurricane Ophelia & Ireland-based manufacturing: Pfizer, Roche & Takeda update

18-Oct-2017 By Flora Southey

Storm Ophelia hit the Green Isle this week, forcing the closure of schools, public institutions, and a number of drug manufacturing sites across the country.

news in brief

GT Biopharma starts making carbamazepine tabets for planned trials

17-Oct-2017 By Gareth Macdonald

GT Biopharma Inc. has started making a non-opioid pain drug that uses a formulation technology licensed from Accu-Break Pharmaceuticals Inc.

Grace licenses Formac's bioavailability enhancement tech

17-Oct-2017 By Gareth Macdonald

WR Grace & Co has licensed rights to a bioavailability enhancement technology from Formac Pharmaceuticals NV.

Cambrex adds potent API capacity citing growing generic opportunities

16-Oct-2017 By Gareth Macdonald

Cambrex Corporation has announced plans to start making high potency APIs at its plant in Milan, Italy citing impending patent losses for small molecule drugs as an opportunity.

update

Switzerland to streamline approval process for cross-border inspections

12-Oct-2017 By Gareth Macdonald

Swiss drug and API manufacturers will soon be able to allow foreign regulators to inspect their facilities without seeking Government approval.

AkzoNobel ups pharma salt capacity in Denmark

10-Oct-2017 By Dan Stanton

AkzoNobel has expanded a facility in Denmark on the back of high demand for pharmaceutical grade salt.

Gilead hands rights to make HIV drug candidate to firms in developing countries

05-Oct-2017 By Gareth Macdonald

Gilead Sciences Inc. has licensed production rights to its candidate HIV drug bictegravir to the Medicines Patent Pool (MPP).

BASF to increase 1,2-PDA capacity with new China plant

25-Sep-2017 By Gareth Macdonald

BASF has announced plans for a specialty amines plant at its site on the Nanjing Chemical Industry Park in China, citing increasing demand from customers in Asia.

BASF ups cost of ethanolamines by €150 per tonne in Europe

21-Sep-2017 By Staff Reporter

BASF says the second price hike within twelve months will restore sustainable margins on the back of increased costs.

Puracap's Wuhan site passes US FDA inspection prompted by ANDA

19-Sep-2017 By Staff reporter

US regulators are satisfied a soft gelatin capsule plant in Wuhan, China is up to code according to Puracap Pharmaceutical LLC.

DowDuPont shifts pharma business in rejigged post-merger split plan

14-Sep-2017 By Gareth Macdonald

Dow’s pharma business will be part of DowDupont’s “specialty chemicals” unit under a revised restructuring plan announced this week.

No fraud, no conspiracy, no error: France and Merck say reformulated Euthyrox is safe

12-Sep-2017 By Gareth Macdonald

A new formulation of Euthyrox linked to a surge in adverse event reports in France is safe, effective and more consistent than the older version of the drug say ANSM and Merck.

Roquette completes Itacel deal and talks Brazilian market potential

05-Sep-2017 By Gareth Macdonald

Roquette has completed its takeover of Brazil-based drug excipient firm Itacel.

Navesta opens LKR1.4bn sterile drug plant in Sri Lanka

04-Sep-2017 By Gareth Macdonald

Navesta Pharmaceuticals had opened a sterile drug manufacturing facility in Horana, Sri Lanka.

Indian Gov outlines plan to favour drugs containing locally made APIs

29-Aug-2017 By Gareth Macdonald

Price controls and procurement programmes would favour drugs containing locally-made APIs under a Government proposal designed to reduce India's reliance on imported ingredients and intermediates.

Ashland to take sales hit of $15-20m after fire at intermediate plant

24-Aug-2017 By Dan Stanton

Ashland says production at a German intermediate facility hit by fire earlier this month will not restart until late September at the earliest.

Reig Jofre says it has resolved penicillin raw materials supply issue

27-Jul-2017 By Gareth Macdonald

Raw material supply problems that impacted its penicillin business last year have been resolved according to Reig Jofre.

STA to supply intermediate for Tesaro 's $117k-a-year cancer drug Zejula

25-Jul-2017 By Gareth Macdonald

Tesaro Inc has hired STA Pharmaceutical Co. Ltd to supply intermediates for its recently approved, $117k-a-year, ovarian cancer drug Zejula (niraparib).

update - comment from Unite

GSK says UK manufacturing cuts not Brexit related

20-Jul-2017 By Gareth Macdonald

GSK has announced a shakeup of its UK network, shelving plans for Ulverston biopharma plant, mooting the sale of its cephalosporin antibiotics business and pledging to invest in HIV and respiratory drug capacity.