NSF International has published a new standard and developed an auditing program that can help pharma companies verify regulatory compliance and strengthen safety and quality across their excipient supply chain.
Porton Fine Chemicals will buy fellow China-based firm Jiangxi Dongbang Pharmaceutical adding intermediates for antivirals and cholesterol busters to its portfolio.
The FDA has tested hundreds of creatively named bogus supplements and found they contain hidden APIs. Take in-Pharmatechnologist.com's quiz and tell us which name is your favourite.
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...
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).
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.
AstraZeneca will spend $40m spinning out its antibiotics R&D business into a separate subsidiary, saying the move will let it focus on its core disease areas.
Shire has acquired privately-held Meritage for an upfront fee of $70m and additional contingent payments based on the achievement of development and regulatory milestones.
The HIV drug API efaverinz could be made faster and more cheaply using continuous manufacturing according to the German team behind a new ‘assembly line’ production method.
An API and intermediates plant set up by Granules India and Ajinomoto Omnichem is a step closer to opening after an offical inauguration ceremony last week.
The Indian Government wants to build API production capacity and revive state run manufacturer Hindustan Antibiotics to cut reliance on Chinese imports.
The International Pharmaceutical Excipients Council of the Americas (IPEC) is raising concerns with the US FDA over ANDA (abbreviated new drug application) guidance related to excipients.
SGS will soon be able to test up to 30 batches of amino acids for impurities per month after adding new analytical methods to those offered at its laboratory in Taunusstein, Germany.
Warburg Pincus-backed HIV drug ingredient firm Laurus Labs has set up a US presence and development facility in a bid to win more North American customers.
AMRI has announced plans to close an API development and manufacturing plant in Wales, UK, after efforts to establish it as a conduit between the US and Europe were deemed unsuccessful.
Banishing kettles, 'Gemba walks' and encouraging employees to report near misses have helped Penn Pharma to remain accident free at its high potency compound manufacturing facility in Wales.
Ongoing demand for large-scale APIs combined with high capacity utilization has driven Cambrex Corporation to allot up to $85m (€70m) for manufacturing expansion in 2015.
Pharmaceutical and chemical manufacturers may have to wait until 2017 to see the benefits of the Transatlantic Trade and Investment Partnership, VP of SOCMA (Society of Chemical Manufacturers and Affiliates) told attendees at InformEx in New Orleans.
Specialty chemicals firm Vertellus will continue to supply antiretroviral drugmakers sodium borohydride following its takeover of a Dow plant in Washington State.
ScinoPharm was hurt by weak US demand for the weight loss pill Qsymia, higher raw material prices and costs associated with its still unapproved plant in China in 2014.
Pfizer must act fast to convince investors it can compete with Roche and Biogen Idec for a share of the spinal muscular atrophy (SMA) market says analyst.
Ranbaxy must sell its acne drug minocycline to Torrent Pharmaceuticals and support the firm while it gains regulatory approval for its API supplier before the US Federal Trade Commission will allow Sun Pharmaceutical Industries to complete its $4bn takeover.
Provectus Biopharmacetuicals is seeking an Indian patent and partner for PV-10 and says it is 'more than a match' for skin cancer competitors like Merck & Co and Bristol-Myers Squibb.
BASF will spend €56m ($62m) to increase production capacity for the excipient PVP by expanding existing plants and introducing manufacturing capabilities at its facility in Shanghai, China.
Biopharma outsourcing growth has helped to boost the bottom line of Lonza, the world’s largest manufacturer of drug ingredients, though a topsy-turvy Swiss franc has caused the company to hold off on making any projections for 2015.
In order to align more closely with ICH’s Q3D guideline for elemental impurities, USP has pushed back until 2018 when its chapter on elemental impurities will apply to industry.
Discovering a new antibiotic candidate and finding out how it kills superbugs without letting resistant mutants escape involved advanced chemistry according to the scientists who determined its structure.
Falling oil prices will cut drug industry materials, manufacturing and logistics costs, and protect firms at risk of generic competition in 2015 according to one industry analyst.
Novacyl Wuxi Pharmaceutical has received a US FDA warning letter for failing to investigate the origin of metal particles found in drugs made at its paracetamol plant in China.
The US FDA’s pre-approval inspection at Hovione’s API plant in Loures, Portugal, covering two NDA filings, resulted in a Form 483 with three inspectional observations.
For the second time the US FDA has rejected two versions of Pozen’s investigational drug candidate because of issues with a supplier’s foreign manufacturing facility.
Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.
AstraZeneca has continued the Big Pharma trend away from small molecule blockbusters and towards a biologics-heavy pipeline, announcing the closure of its Pulmicort facility in Massachusetts.
Cubist will give Merck & Co leadership of the antibiotics sector according to one analyst who says renewed interest expressed by GSK, Roche and Sanofi has not produced any Ph III candidates.
