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Ipca halts API shipments to US following 483 at Indian plant

24-Jul-2014 - Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.

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

23-Jul-2014 - Onyx Scientific has been contracted to develop and manufacture APIs for clinical trials by charitable group Cancer Research UK.

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

23-Jul-2014 - 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.

European Pharmacopoeia plans revisions of elemental impurities guideline

23-Jul-2014 - As the International Conference on Harmonisation (ICH) signs off on a new tripartite guideline related to elemental impurities, the European Pharmacopoeia Commission will revise its texts to ensure consistency. 

New nanotech excipient offers cheaper solubility option say scientists

22-Jul-2014 - Scientists in Sweden have developed a magnesium carbonate-based excipient they claim is a low-cost nanotech alternative to silica for drugmakers struggling to formulate insoluble APIs.

Drug ingredients were key to Ireland's manufacturing growth in 2013 says CSO

21-Jul-2014 - Basic pharmaceuticals including APIs became even more important revenue generators for Ireland in 2013 according to new data released by the Central Statistics Office (CSO).

Janssen's tramadol supply chain ready for DEA's rescheduling deadline

16-Jul-2014 - Janssen Pharmaceuticals is prepared for Tramadol's reclassification by the US Drug Enforcement Administration (DEA) and says the supply of its versions of the opioid analgesic will not be interrupted.

FDA proposed rule could delay import of excipients, PhRMA says

15-Jul-2014 - Although industry group PhRMA has called for the full implementation of a proposed rule that would allow the US FDA to destroy detained drugs deemed to be counterfeit or unapproved, the group also warns that such destruction could lead to manufacturing delays.

Apotex hit with warning letter on troubled API facility in India

09-Jul-2014 - Apotex is getting reprimanded once again for its API facility in Bangalore, India, after the company failed to adequately respond to an FDA Form 483 over data integrity issues, according to an FDA warning letter dated June 16 .

Merck Millipore says Indian lab can boost generics quality

07-Jul-2014 - Merck Millipore, the life sciences tools division of Merck KGaA, has launched a solid dose formulation lab in India, its first outside Europe.

News in brief

Aarti Drugs considers formulations driven plant acqusition

07-Jul-2014 - Aarti Drugs has said it is considering buying an unnamed manufacturer in Himachal Pradesh, India to expand its drug formulations business

Hospira finally completes Orchid plant acquisition

07-Jul-2014 - 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.

Bulk ingredient prices skyrocket in US as payers clamp down

03-Jul-2014 - 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.

News in brief

Medichem opens Malta HPAPI plant

01-Jul-2014 - Medichem has opened an API plant in Malta touting the country’s “unique patent situation” as an attractive option for generic drugmakers.

Onyx invests in continuous flow following API demand

01-Jul-2014 - UK API-maker and contract research organisation (CRO) Onyx Scientific is installing equipment for continuous flow manufacturing to offer customers an alternative to batch manufacturing.

IMCD expands IPO citing demand and desire for deals

26-Jun-2014 - Dutch API and excipients distributor IMCD has increased the number of shares it will make available in its initial public offering (IPO), citing demand.

Oasmia's vitamin A excipient tech attract global pharma collaborator

26-Jun-2014 - Oasmia Pharmaceutical AB has teamed up with a “global pharmaceutical company” interested in its vitamin A-based nanoparticle formulation tech in a move that expands its business model to drug development partnering.

update

Ethanol diluent in injectables an intoxication risk says US FDA

24-Jun-2014 - The use of ethanol as a diluent in injectables is under the spotlight following a new US FDA warning that its presence in the cancer medicine docetaxel poses an intoxication risk.

Big Pharma Insourcing replacing Asian suppliers as competition for western CMOs

23-Jun-2014 - 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

WHO and USP programme to help manufacturers of key drugs

19-Jun-2014 - The WHO, the United States Pharmacopeial Convention (USP) and the US Agency for International Development (USAID) will work with regulators to help countries manufacture a key tuberculosis drug.

Roche: ‘If suppliers don’t open up their books, then we are done’

18-Jun-2014 - Drug raw materials suppliers have not recognised their potential value to biopharmaceutical customers according to Roche which has called for a transformation in the vendor relationship.

SOCMA highlights contribution to facility security report

16-Jun-2014 - A US presidential report on plans to improve chemical facility safety and security has incorporated a number of recommendations from the Society of Chemical Manufacturers and Affiliates (SOCMA).

Doubts over CDSCO claim it can assess an API supplier in 30 days

12-Jun-2014 - A European expert has cast doubt on a claim by Indian regulator CDSCO that it can assess and confirm the quality of an API supplier’s manufacturing operations in writing in just 30 days.

Acino appeal rejected: ruling underlines EC powers in light of GMP failures

11-Jun-2014 - The European Commission (EC) can order the withdrawal of medicines that are not produced in accordance with GMP without having to prove they pose a specific health risk after a ruling in the EU Court of Justice.

Merck's $3.85bn HCV acq focused on 'valuable' nucleotide pipeline

10-Jun-2014 - Merck & Co. says the $3.85bn (€2.8bn) acquisition of Idenix will springboard its oral hepatitis C programme but according to an analyst is unlikely to threaten Gilead’s $1,000 pill Sovaldi.

Spotlight

G-CON: Pfizer investment an endorsement of 'podular' manufacturing

Pfizer investment an endorsement of 'podular' manufacturing, says G-CON

G-CON says a multi-million dollar investment by Pfizer could hasten the “paradigm shift” in pharma manufacturing towards...

US FDA enforcement evolving in India will drive compliance costs

Indian firms must invest in compliance as USFDA ups enforcement, says S&P

Indian drugmakers must invest heavily in compliance processes in response to the US FDA’s “aggressive surveillance” and...

Ease regulations to cure drug industry antibiotic resistance, says RPS

Ease regulations to cure drug industry antibiotic resistance, says RPS

The current model of antibiotic development “is broken,” says the Professor of Pharmaceutical Innovation at Kings College,...

Zogenix adds abuse deterrents to Zohydro painkiller

Zogenix adds abuse deterrents to Zohydro painkiller

Zogenix has modified its much-debated painkiller Zohydro with abuse-deterrent formulations.

Afrezza approval: Validation for Mannkind's drug and delivery tech

Afrezza approval: US FDA validation for Mannkind's drug and delivery tech

The US FDA approved Afrezza last weekend after deeming that the inhaled insulin drug and the dry...

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