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APIs (active pharmaceutical ingredients)

News headlines

EMA: TTIP and inspection databases a way of improving global manufacturing standards

31-Mar-2015 - Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.

‘Game changer’: latest GDP rules spell full traceability for APIs

26-Mar-2015 - Makers and distributors of APIs (active pharmaceutical ingredients) will have to track their products throughout the supply chain and meet rules on cold chain transport and outsourcing under revised guidance from the European Commission.

AstraZeneca teams with Harvard to make human beta cells for drug screening

25-Mar-2015 - Sourcing human beta cells may soon no longer be a challenge for AstraZeneca diabetes researchers thanks to a new partnership with stem cell scientists at Harvard University.


Novasep joins Lonza as Mydicar API producer in deal with Celladon

25-Mar-2015 - Novasep and Lonza will both make the API for Celladon's heart attack therapy, Mydicar.

AbbVie bucks Puerto Rico departure trend with $30m expansion

25-Mar-2015 - AbbVie is investing $30m (€27m) in contract manufacturing facilities in Puerto Rico and plans to create 100 jobs over the next two years.

FDA plans new approach to manufacturer inspections in India

24-Mar-2015 - Several FDA officials are currently visiting India and meeting with manufacturer CEOs and government officials to discuss the way the agency’s inspections are expected to change over time.

US diabetics pay most for drugs, but world’s poorest bear the biggest economic burden

23-Mar-2015 - Further evidence US diabetics pay more for drugs than sufferers in comparable countries has emerged this month in a study assessing the diseases’ economic impact.

Dispatches from DCAT

Message is clear: Europe is in trouble in terms of pharma growth, experts say

17-Mar-2015 - The European pharma market isn’t likely to deliver much growth over the next five years as generic markets commoditize, IMS Health VP Graham Lewis warned participants at the DCAT (Drug, Chemical and Associated Technologies) conference on Monday.

US DEA drug ingredient quota review failings increasing shortages says GAO

16-Mar-2015 - The DEA's mismanagement of the controlled substance API quota system and its poor relationship with the FDA have exacerbated drug shortages according to the US GAO.

News in brief

Porton Fine Chem buys fellow China intermediates firm Dongbang

16-Mar-2015 - Porton Fine Chemicals will buy fellow China-based firm Jiangxi Dongbang Pharmaceutical adding intermediates for antivirals and cholesterol busters to its portfolio.

FDA wins Ranbaxy ANDA approval suit as judge raises ‘grave concerns’ over FDA actions

13-Mar-2015 - Despite slamming the US FDA for tentatively approving two Ranbaxy ANDAs (abbreviated new drug applications) for the first Nexium and Valcyte generics, US District Judge Beryl Howell said last week the agency can revoke the approvals because of manufacturing concerns.

AMRI sets sights on acquiring Indian API manufacturer, CEO says

11-Mar-2015 - Following its three acquisitions over the last year, AMRI is now looking to extend its footprint into India further with the acquisition of a FDA-approved API site, William Marth, president and CEO of AMRI, told attendees at the Barclays Global Healthcare Conference on Wednesday.

Novacyl’s acetyl salicylic acid plant in Thailand hit with FDA warning letter

11-Mar-2015 - For the second time this year, the FDA has issued a warning letter to API (active pharmaceutical ingredient) and intermediate manufacturer Novacyl and this time it’s for the company’s manufacturing site in Thailand.

Johnson Matthey builds HPAPI site in Scotland

11-Mar-2015 - API- and catalyst-maker Johnson Matthey has built high containment facilities for potent products at its site in Edinburgh, Scotland.

J&J pleads guilty, pays $25m over manufacturing adulterated infants’, children’s OTC medicines

10-Mar-2015 - J&J unit McNeil-PPC has admitted breaking US law by selling contaminated liquid medications, including Infants’ Tylenol and Children’s Motrin, deemed adulterated under the federal Food, Drug and Cosmetic Act (FDCA).

EU safety logo set to tighten net on dodgy food supplement sales

10-Mar-2015 - The Danish and Austrian authorities have warned against toxic food supplements ahead of an EU-wide safety logo set to crack down on illegal retailers posing as online pharmacies.

Pfizer's plant in Little Island to stay open after higher Lipitor demand

10-Mar-2015 - Pfizer will continue to make Lipitor at its plant in Little Island, Ireland after an increase in demand for the cholesterol buster.

Patheon: Irix deal about US and Canadian customer demand for local APIs; all staff to be retained

05-Mar-2015 - Irix Pharmaceuticals will cater for North American customers’ desire for local supply according to Patheon, which says it plans to retain the API firm’s 180 staff.

Hundreds of API suppliers with plants in new Indian state Telangana need to update EDQM

04-Mar-2015 - As many as 450 API and intermediate suppliers in India's newest State - Telangana – need to log their changed addresses with the EDQM before August.

Health Canada looks to crack down further on noncompliant manufacturers

04-Mar-2015 - Health Canada is telling drug and API manufacturers that it’s going to ramp up announced and unannounced inspections due to concerns raised around APIs and data integrity, and the findings will be published online beginning next month.

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