In order to ensure uniformity on the state and federal levels, India’s CDSCO (Central Drugs Standard Control Organization) has released seven procedural criteria for state drug inspectors to abide by.
In a sweeping report on the industry as a whole, the European Commission says that with an annual output of €220bn, and nearly 800,000 employees, the pharma industry is vital for the EU economy, though more needs to be done to meet its full potential.
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.
CMO (contract manufacturing organization) AMRI has agreed to acquire Oso Biopharmaceuticals Manufacturing for $110m in cash and thereby expand to late-stage and commercial product manufacturing.
Biopharma is ramping up the outsourcing of some of the easier tests while tasks such as downstream process development and QbD services are being outsourced less, according to a new survey.
Capsugel is no longer a simple capsule provider but a differentiated player in the CDMO industry, the firm says as it wins a scale-up manufacturing contract for Chiasma and Roche’s oral octreotide candidate.
As pharma manufacturers look to cut costs and increase quality, over 70% of industry executives interviewed for a recent CPhI report say they are actively investing in manufacturing techniques and technologies to achieve these goals.
Biopharma executives believe there will be strong growth in domestic R&D activities and biopharma manufacturing, but fewer workers will be needed as efficiencies in productivity are achieved across the industry, according to a new survey from industry...
Thermo Fisher has launched a pump technology designed for applications across the bioprocessing production line and usable with "all" bioprocessing tech.
Molecular Profiles has invested in hot melt extrusion (HME) and nano milling capabilities citing client demand for improving the bioavailablity of drugs.
The thin profit margins associated with relatively simple sterile products has led to a reluctance to invest in operations and shortages, according to an industry expert.
‘Podular’ manufacturing systems will dominate facility design within five years, say G-CON and GEA who have teamed with Pfizer to create a flexible, repurposable and portable facility.
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.
Merck, Novartis, GlaxoSmithKline, Celgene and industry groups are taking issue with recent FDA draft guidance on how manufacturers can reject or limit agency inspectors.
A collaboration to develop portable, flexible and continuous processing systems has the potential to transform oral solid dose (OSD) manufacturing, according to Pfizer, GEA and G-CON.
In the wake of recent bribery scandals, Boehringer Ingelheim (B-I) has called for stricter regulations in China, as it plans to triple production at its Shanghai manufacturing site.
Cubist is issuing a nationwide recall of four lots of its antibiotic injection Cubicin after one of the company’s CMOs had a manufacturing issue that caused glass particulates to contaminate the lots.
German CMO Rentschler landed APN311 production deal thanks to location and cell culture based manufacturing skills according to BioPharma Apeiron Biologics.
Over the next 10 years CMO Corgenix will contract manufacture EDP Biotech’s diagnostic test to detect the early stages of colon cancer, the companies agreed last week.
Wockhardt remains confident its troubled manufacturing facility in India will be back up and running in three months after receiving a certificate of non-compliance from the MHRA.
The Aspen Group, a generic pharmaceutical company, is moving further into the manufacturing business with the purchase of Merck’s API manufacturing sites in the Netherlands and Iowa.
Manufacturers’ quality issues were among the most prevalent reasons for drug shortages, according to a survey conducted by the ISPE (International Society for Pharmaceutical Engineering).
ATMI has started selling a new cGMP-compliant fill finish platform in a continuation of its focus on what it says is the growing single-use tech market.
GlaxoSmithKline’s contract manufacturer has experienced unspecified manufacturing issues that are expected to set back supplies of its restless leg treatment Horizant until June.
The US FDA has reprimanded and halted all imports from Japanese API manufacturer Asada Milling Co. after finding its manufacturing equipment “corroded, rusted, chipped of paint, and coated with an unidentified white powder,” the agency said in its warning...
As excipient suppliers are inundated with similar requests from users regarding quality and raw material sources, IPEC (International Pharmaceutical Excipients Council) is looking to streamline the exchange of information between the different companies.
The US FDA listed failure to ensure product sterility or explain why some batches were only partially released among criticisms of Apotex in a warning letter published this week.
As the Food and Drug Administration (FDA) ramps up its inspections of foreign pharma manufacturers in an attempt to root out GMP inconsistencies and faulty processes, a recent warning letter to Taiwanese manufacturer Beanne Chemical may serve as an example...
