Failure to test ingredients’ identity in an over-the-counter drug product is one of the violations that landed Polaroisin International a US FDA warning letter.
Bayer has pulled-out of a development and licensing deal for a pseudoephedrine containing product based on Acura Pharmaceuticals’ methamphetamine resistant technology, Impede.
Mappel Indústria de Embalagens says it did not know the US would regulate the dermacosmetic products made at its Sao Paulo plant as OTC drugs after FDA warning.
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).
By dropping 44 more employees, Novartis has completed the final phase of the planned restructuring of its once-beleaguered Lincoln, Nebraska manufacturing facility.
The US FDA has given stakeholders more time to comment on the 40-year old monograph system used to regulate OTC drugs and reiterated its concerns that the approach does not allow it to keep up with new drug safety testing advances.
Albemarle has agreed to sell its ibuprofen business to US chemical intermediates firm SI Group in a deal that will also see it divest the anaesthetic agent, propofol.
Johnson & Johnson (J&J) dominated recall and quality control (QC) news over the past year but others also faced issues. in-PharmaTechnologist presents five of our most read QC articles of 2010.
Johnson & Johnson (J&J) has expanded its US OTC drug recall after revealing that many more products than first thought may be contaminated by the wood dye, 2,4,6-tribromoanisole (TBA).
Profits doubled at MWV’s healthcare division in the third quarter, despite slightly lower sales, as the packaging company’s efforts to focus on high return opportunities and maximise production efficiency paid dividends.
The US Food and Drug Administration (FDA) has given stakeholders an
extra month to get their views in on scrapping epinephrine inhalers
containing CFCs.
Growing demand has prompted tableting specialist Meldex
International, formerly BioProgress, to launch a new sales and
distribution hub in Germany, with the UK firm also announcing a new
manufacturing contract for its XGel film.
After dismal second quarter results Patheon is stepping up its
resolve for 'damage control' and indicated that further cutbacks at
its problematic Puerto Rico plant are imminent.
US contract manufacturer PharmaFab has agreed to stop the
manufacturing and distribution of some of its drugs after
regulators found they were produced illegally.
Paladin Labs has reached an agreement in principle to acquire the
outstanding shares of BioEnvelop Inc, which develops, manufactures
and markets rapidly dissolving edible films for use as delivery
systems in the pharmaceutical and...
Canadian contract manufacturer Patheon has announced its plans to
restructure its Ontario network of drug manufacturing facilities in
order to improve its profitability.
US firm Skinvisible last week announced that its polymer-based
delivery system has been licensed to pain relief company DRJ for
use in a new topical analgesic product.
A thin-film delivery system that looks like a postage stamp and
dissolves rapidly on the tongue could give new momentum to Adams
Respiratory Therapeutics' portfolio of prescription and
over-the-counter medicines (OTC) for the...
GlaxoSmithKline (GSK) has acquired licensing rights outside the US
to the over the counter (OTC) weight-loss medication orlistat,
previously marketed by Roche.
Major pharmaceutical player GlaxoSmithKline (GSK) has begun
construction of a €23m facility in County Waterford, Ireland. The
new facility is already under construction at the company's
consumer healthcare manufacturing site...
Almost 130 jobs will be lost at BASF's Minden site as the company
succumbs to growing pressure from the Asian generic active
pharmaceutical ingredient (API) market.
US drugmaker Perrigo has started selling a new nicotine gum to help
smokers quit the habit in the US, challenging the dominance there
of Pfizer and GlaxoSmithKline's Nicorette product.
Belgium's UCB has been granted approval in the US for the first
chewable formulation of an antihistamine designed to make it easier
to treat children for hayfever.
The new agreement between BioProgress and an unnamed US
over-the-counter pharmaceuticals firm could double the UK company's
capacity to manufacture cellulose films for drug encapsulation,
according to chief executive Graham Hind.
Japan's Ministry of Health, Labour and Welfare has ordered
companies to stop producing over-the-counter (OTC) pharmaceuticals
containing phenylpropanolamine (PPA), linked to an increased risk
of haemorrhagic stroke.