Breaking News on Global Pharmaceutical Technology & Manufacturing

APIs (active pharmaceutical ingredients)

News headlines

$100m API investment a boost to Gilead's in-house capacity

28-May-2015 - Sovaldi maker Gilead Sciences has opened a new laboratory and is investing a further $100m (€91m) for API manufacturing at its site in Canada.

Novartis to assess biologics with micro-sugar-needle delivery tech

27-May-2015 - Novartis has partnered with Google-backed Rani Therapeutics to assess an oral platform which delivers biologics through the intestinal wall using needles made of sugar.

April US chemical output for pharma down says ACC; SOCMA welcomes R&D tax credit move

27-May-2015 - US production of chemicals for the drug industry fell in April according to data released days after renewed calls for permanent tax breaks to help American manufacturers compete globally.

Lonza set to get commercial Adva-27a contract if cancer drug is approved

27-May-2015 - Lonza shipped a sample batch of a drug for resistant cancers this week and is set produce commercial supplies if the Phase I candidate goes on to be approved says Sunshine Biopharma. 

Home-brew morphine: Is opiate production about to get way too easy?

21-May-2015 - Access to yeast strains modified to produce opiates for cheaper, more effective pain meds must be strictly controlled according to researchers who warn that stopping criminals using such API manufacturing routes to make illegal narcotics is vital.

EMA: show clinical justification for combination drugs

20-May-2015 - The EMA has released guidelines on developing combination drugs with more than one active pharmaceutical ingredient (API).

European freeze-drying market heats up: Symbiosis invests citing high demand

19-May-2015 - Symbiosis Pharmaceutical Services has launched a bulk freeze drying offering for APIs and intermediates, citing new contracts as a driver for the investment.

Endo buys Par, Lupin enters Brazil... it's been a busy week in generics

19-May-2015 - Endo’s $8bn takeover of Par Pharmaceutical is expected to shake-up the generics sector, while Lupin is expanding its South American network – welcome to In-Pharmatechnologist’s M&A round-up.

News in brief

US FDA investigates AZ, J&J and B-I's type 2 diabetes drugs after adverse events

18-May-2015 - Diabetes drugs made by J&J, AstraZeneca and Boehringer-Ingelheim are being investigated by the US FDA after 20 cases of acidosis resulting in hospitalisation were recorded.

Dr Reddy’s yen for growth: Indian generics and API firm plans to partner in Japan

18-May-2015 - Dr Reddy’s has set out to build in the Japanese market days after revealing that higher generic and API sales elsewhere had been pegged back by currency fluctuations.

SAFC expands ADC and bulk drug manufacturing in CA, MO

13-May-2015 - SAFC has announced investments in gene therapy manufacturing sites in Missouri and California.

EMA: clinical data may not be needed for topical comparisons

13-May-2015 - The EMA (European Medicines Agency) is changing the way it assesses quality of topical drugs for marketing authorisations.

Siegfried set to buy custom synthesis and API units from BASF for $300m

07-May-2015 - BASF says it remains committed to the pharma industry despite plans to divest its custom synthesis business and around 100 APIs and intermediates to Siegfried Holding.

FDA needs to conduct all generic manufacturing inspections requested by reviewers, report says

07-May-2015 - Although the US FDA has drastically increased its preapproval inspections of generic drug makers worldwide, the agency failed to conduct all of the inspections requested by its own generic application reviewers, according to a report from the HHS Office of the Inspector General (OIG).

AMRI riding high on API acquisitions, expects more M&A to come

06-May-2015 - AMRI attributed a robust first quarter to its growing API business and recent acquisitions, and says to expect more M&A activity this year.

News in brief

BASF ups price of EOAs in Europe

05-May-2015 - BASF has hiked up the price of ethanolamines in Europe citing increased cost of raw materials and continuous demand.

API firms stand to gain by seeking prequalification says the WHO

05-May-2015 - Persuading API manufacturers to seek prequalification is a challenge according to the WHO, which wants to raise awarness about the process and the positive impact it has on a suppliers' reputation.

Indian API and generics firms want a bigger share of the Japanese market

04-May-2015 - Indian generics firms see opportunities in the Japanese drug market according to a trade delegation that visited Tokyo last week seeking supply contracts.

FDA calls on manufacturers to begin switch from batch to continuous production

01-May-2015 - Though making the switch from batch to continuous manufacturing may be difficult, costly and time consuming, pharma manufacturers and CMOs should begin to consider the switch as in the long-run it will end up saving companies time, money and space, FDA’s CDER Director Janet Woodcock told congressmen in a hearing Thursday. 

IBEF: India still attractive for Japanese pharma despite Daiichi Sankyo's Ranbaxy experience

30-Apr-2015 - Japanese drug firms eyeing international investments should not be put off by Daiichi Sankyo’s turbulent ownership of Ranbaxy according to an Indian delegation in Tokyo last week to seek collaborations.

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