In an exclusive interview, Patheon Executive Mike Lehmann talks DSM integration, further growth and how consolidation amongst CMOs may be driving strategic alliances with pharma.
Sun Pharma’s antibiotic facility import alert is the latest blow to the Indian drug industry but is unlikely to impact revenues or cause US shortages, the firm says.
The UK Government has set out to make Britain a more attractive place from which to source drugs and ingredients by awarding a series of taxpayer funded grants to supply chain focused innovation projects.
Patheon has merged with Royal DSM's pharmaceutical products business to form DPx in a $2.65bn (€1.9bn) deal that analysts believe has created the world's second biggest CMO.
Nearly a quarter of drugs made in Jammu & Kashmir and 10% of those produced in Himachal Pradesh are substandard according to new testing data published by CDSCO.
WuXi PharmaTech has revealed that demand for its manufacturing services increased significantly last year and forecast that its "open access" approach will help it sustain growth into 2014.
Operations will continue and may even be enhanced at DSM’s Australian taxpayer-funded biologics plant following a merger with Patheon, the Queensland Government says.
Boehringer Ingelheim says it will pump a further €330m ($453m) into a German manufacturing facility critised by the US FDA in its rejection of the drug empagliflozin.
Columbia Laboratories has reported strong annual results despite a fourth quarter affected by Actavis taking the manufacture of vaginal gel Crinone in-house and the “lumpiness” of Merck Serono.
Addiction doctors have petitioned the US FDA to prevent Zohydro ER, the first single-entity hydrocodone painkiller, hitting the market this month citing its potential for abuse. Its maker, Zogenix, has been tight-lipped on whether the drug’s formulation...
Cobra Biologics is looking for more scientists with plasmid production skills after BioCancell became the fifth firm in a year to ask the CMO to manufacture a DNA-based gene therapy candidate.
Jubilant HollisterStier says the Warning Letter in place at its Montreal, Canada facility did not affect manufacturing or business as - twelve months later – the US FDA upgrades the site to ‘acceptable.’
The European Medicines Agency (EMA) stressed the potential benefits of continuous process validation in guidance issued this week and underlined that data submitted by drugmakers must demonstrate the adequacy of production operations at each site.
National prioritization, investments in healthcare infrastructure and building better epidemiological and cost databases could bring more innovative medicines to middle-income countries, according to an independent study conducted by Charles River Associates.
As part of an effort to ease the transition between clinical and commercial launch for blister products, Almac has added new blistering technology at its US commercial packaging facility in Audubon, PA.
Pfizer says its hypothyroid drug Levoxyl will be available within a week after a musty smell coming from the oxygen-absorbing canister stopped production last February.
Tokyo, Japan-based JCR Pharmaceuticals has asked UK firm Plasticell to help develop differentiation protocols for its range of candidate stem cell-based therapies.
Cellceutix has selected Dr. Reddy’s Custom Pharmaceutical Services (CPS) for the formulation of its defensin mimetic drug Brilacidin for use in ophthalmic and otitis infections.
Ranbaxy has temporarily halted all shipments from two API plants currently under a US FDA consent decree, although both the firm and an analyst say a shortage is unlikely.
Development of a new quality "super office" was motivated by a desire to simplify oversight and is not a response to the recent spate of problems at overseas suppliers, says the US FDA.
A longer than expected upgrade to one of its injectable plants has caused Pfizer to announce that there is a shortage of methylprednisolone sodium succinate injections.
Ben Venue Laboratories, a Boehringer Ingelheim subsidiary that was recently closed after a spate of quality problems, issued a US-wide voluntary recall for its Acetylcysteine Solution 10% at the patient level.
The European Commission (EC) has increased the pressure on Ireland, Italy, Poland and Slovenia to fall into line with other EU member States and introduce anti-drug counterfeiting legislation.
CMO Cytovance Biologics has entered into a manufacturing agreement with Pamlico Biopharma to develop a group of three human IgG monoclonal antibodies intended for the treatment of Streptococcus pneumoniae infections.
AMRI says it intends to expand its API business to target both generics and more complex molecules after reporting record full year revenue from contract services.
The US FDA has upgraded Hospira’s troubled Rocky Mount, North Carolina plant to VAI (voluntary action indicated) status though its 2010 Warning Letter still stands.
Cobra says it will no longer need to rely on third-parties for its biologics quality control tests after receiving an extension to its GMP certification at a Swedish facility.
Perrigo Company has reported a 40% drop in contract manufacturing revenue year-on-year due to a key client, assumed by analysts to be J&J, returning to OTC in-house production.
Pfizer says its ‘off the shelf’ aseptic processing capacity is shifting the paradigm of pharma manufacturing, with emerging markets and personalised medicine driving the change.
Recipharm says it has not decided whether to go public and list on the Swedish stock market after reports suggested it is preparing to join the exchange.
Novartis has confirmed that pharma jobs will be reallocated in 2014 in a continuation of the productivity drive that saved the firm $2.8bn (EUR2bn) last year.
Shipments of chicken pox vaccines from a troubled Belgian facility should recommence in early Q2 2014, says GSK, though the root cause of the manufacturing issues are still unknown.
CordenPharma has received certification of Potent Compound Safety at a US plant and joins a growing list of drugmakers looking to assure HPAPI safety, according to SafeBridge Consultants.
Catalent has filed an initial public offering (IPO) with the SEC to raise $100m though this could reach upwards of $500m, according to one investment firm.
