ViiV teams with Russian manufacturer
03-Nov-2011 By Gareth Macdonald
ViiV, GSK and Pfizer’s HIV joint venture, has partnered with Russia’s JSC Binnopharm to boost manufacturing capacity in the country.
Novozymes rolls out new HA product
update
03-Nov-2011 By Gareth Macdonald
Novozymes Biopharma says its new hyaluronic acid has sustainability, safety and production benefits for the pharmaceutical manufacturing sector.
02-Nov-2011 By Natalie Morrison
Using chiral metal surfaces in drug manufacturing could save companies time and money, say researchers at University of Cambridge.
Delivery vehicles can revitalise RNAi sector; AAPS panel
31-Oct-2011 By Nick Taylor
Aptamers and dendrimers can revitalise the faltering siRNA sector by solving delivery problems, AAPS panelists said.
Excipient auditor certification scheme ready for 2012 launch, says IPEC
24-Oct-2011 By Gareth Macdonald
Industry groups developing certification standards for third-party auditors of pharmaceutical excipient manufacturers say they are ready to launch the scheme next year.
Merck plans $250m Singapore manufacturing expansion
24-Oct-2011 By Nick Taylor
Merck & Co is investing $250m (€180m) in its Singapore manufacturing capabilities as part of an expansion push.
Carbogen Amcis teams with liposomal delivery tech firm for HP API biz
20-Oct-2011 By Gareth Macdonald
Carbogen Amcis has signed a strategic deal with formulations specialist Polymun Scientific in a agreement designed to support the development of its high potency manufacturing business.
Sri Lanka to increase local drug production with pharma hub
20-Oct-2011 By Nick Taylor
Sri Lanka is setting up a 48 acre pharma manufacturing industrial zone to boost local production.
Avantor to add tamper-evident seals to raw material containers
20-Oct-2011 By Nick Taylor
Avantor is to offer tamper-evident seals on all its pharma raw material and excipient containers by the end of the year.
GSK hit with warning letter as FDA finds faults with UK site
19-Oct-2011 By Nick Taylor
The FDA has sent GSK a GMP warning letter after finding failings in steps to prevent microbiological contamination at a UK site.
Canadian drug shortage plan fails to tackle problems; analyst
19-Oct-2011 By Nick Taylor
Canadian pharma manufacturers’ plan to stop drug shortages by sharing information fails to tackle underlying concerns, an analyst said.
API and intermediates drive Granules India’s Q2 growth
18-Oct-2011 By Gareth Macdonald
Granules India says higher demand for APIs and pharmaceutical intermediates combined with manufacturing productivity gains helped drive quarterly growth.
Economic reform drove Indian pharma manufacturing boom
17-Oct-2011 By Nick Taylor
Liberalisation of Indian regulations in the early 90s caused a surge in manufacturing capacity but a dip in efficiency, research claims.
Porcine trypsin guidance may apply retrospectively; EMA
13-Oct-2011 By Nick Taylor
The EMA may apply proposed porcine trypsin guidelines to existing products, such as a GSK vaccine, to cut viral contamination.
EPA proposes fine for API plant over waste allegations
12-Oct-2011 By Nick Taylor
The US EPA plans to fine API manufacturer Rhode Technologies for alleged hazardous waste failings at its plant.
FDA releases final guidance on anti-counterfeiting excipients
12-Oct-2011 By Nick Taylor
The FDA has published final guidance on the use of excipients as anti-counterfeiting tools in solid oral dosage forms.
Sanofi Pasteur says it will recoup losses in India with new manufacturing plant
11-Oct-2011 By Natalie Morrison
Sanofi Pasteur says it will regain lost ground in India through its new state-of-the-art vaccine manufacturing plant.
AstraZeneca plans Chinese manufacturing facility to meet local demand
11-Oct-2011 By Natalie Morrison
AstraZeneca has broken ground on a $200m (€147m) manufacturing facility in China to meet soaring demand in the country.
Biologics growth prompts IMB cold-chain distribution guidance
11-Oct-2011 By Nick Taylor
The Irish Medicines Board (IMB) has published guidance for cold-chain storage and transport of APIs and finished products.
11-Oct-2011 By Gareth Macdonald
The United States Pharmacopeial Convention (USP) has forged closer ties with Russian regulators to help tackle substandard pharmaceuticals and harmonize quality standards.
Aid agency wants Brazil to streamline validation to combat Chagas API shortages
10-Oct-2011 By Gareth Macdonald
Medecins Sans Frontieres (MSF) wants Brazil to streamline its validation process for the API benznidazole after global stocks of the Chagas disease treatment drop to critical levels.
Rituximab success paves way for plant produced mAbs
10-Oct-2011 By Nick Taylor
iBio is expanding use of its green plant technology to biosimilar mAbs after producing rituximab using the system.
Vetter opens new US production facility
06-Oct-2011 By Natalie Morrison
Vetter says it will reduce API wastage through its new US production facility for the filling of syringes, cartridges and vials.
Melanoma therapy costs could be slashed thanks to new device, says OncoSec
06-Oct-2011 By Natalie Morrison
The price of melanoma therapy could soon be slashed thanks to a new delivery system developed by US firm OncoSec.
Avacta allies with Pall to serve SE Asian biopharm
06-Oct-2011 By Nick Taylor
Avacta has allied with Pall to offer biopharm manufacturers in Singapore and South Korea tools to assess formulation viability.
ScinoPharm goes public in preparation for expansion opportunities
05-Oct-2011 By Natalie Morrison
Active pharmaceutical ingredient (API) manufacturer ScinoPharm has gone public in a bid to raise funds for its upcoming expansions.
Solvias and RohnerChem team on API development and manufacturing
05-Oct-2011 By Gareth Macdonald
Solvias and RohnerChem have set up a research and manufacturing services partnership designed to accelerate the production, scale-up and commercialisation of APIs.
FDA awards $35m to improve US drug production
05-Oct-2011 By Nick Taylor
The FDA has awarded a $35m (€26m) grant to make US drug production less expensive and reverse the offshoring trend.
Tabex maker Sopharma opens new Serbian plant
04-Oct-2011 By Gareth Macdonald
Smoking cessation drugmaker Sopharma has opened its new manufacturing plant in the Serbian capital Belgrade.
Aesica plans expansion in US & Asia after investment
03-Oct-2011 By Natalie Morrison
CDMO Aesica is to add manufacturing capacity in Asia and the US following a cash injection from private equity firm Silverfleet Capital.
Round-up of SAFC's Glasgow conference
03-Oct-2011 By Natalie morrison
SAFC will extend its focus on high potency production through a number of new investments.
TGA proposes adopting 15 EMA guideline documents
03-Oct-2011 By Nick Taylor
The Australian TGA is considering adopting EMA guidance on residual solvents, genotoxic impurities and other GMP topics.
29-Sep-2011 By Nick Taylor
The US FDA has filed a permanent injunction against a US drugmaker and sent a warning letter to a Chinese API producer following cGMP problems.
Lonza inks stem cell production pact with Mesoblast
28-Sep-2011 By Nick Taylor
Lonza may build a stem cell production facility dedicated to manufacturing Mesoblast products after inking an alliance.
CMLE OKed to start commercial API production at Netherlands plant
27-Sep-2011 By Gareth Macdonald
Cambridge Major Laboratories Europe (CMLE) is set to start commercial API manufacturing at its facility in the Netherlands after approval by Dutch regulators.
ProMetic supplying adsorbent to Chinese biosimilar biz
26-Sep-2011 By Nick Taylor
ProMetic Life Sciences is supplying an affinity adsorbent to a Chinese biopharm for use in scale-up of a biosimilar.
Crystallisation modelling can improve scale up, PSE says
26-Sep-2011 By Nick Taylor
Process Systems Enterprise (PSE) has developed crystallisation modelling software to improve throughput and simplify scale-up.
UK drug re-developer sees business in pharma turmoil
22-Sep-2011 By Nick Taylor
Oxford Pharmascience expects the challenges facing biopharm to drive interest in its drug delivery and reformulation technologies.
FDA hits Indian API plant with warning letter & import alert
22-Sep-2011 By Nick Taylor
The FDA has issued a warning letter and import alert to an Indian API manufacturer after finding major cGMP failings.
Rx-360 begins audit sharing to raise ingredient quality
21-Sep-2011 By Nick Taylor
Rx-360 has begun its audit sharing programme to increase knowledge about suppliers and the quality of pharmaceutical raw materials.
Reformulation targeted in FDA unapproved drug plan
20-Sep-2011 By Nick Taylor
The FDA is targeting companies that reformulate drugs to evade enforcement as it tries to crackdown on the 1000s of products marketed without approval.
Pharma discharge checks called for to protect waterways
20-Sep-2011 By Nick Taylor
Researchers have called for closer monitoring of pharma manufacturing discharges after detecting endocrine disruption in fish downstream from a Sanofi plant.
Berkshire Hathaway completes $9.7bn Lubrizol acquisition
20-Sep-2011
Chemicals supplier Lubrizol was bought by Warren Buffet’s Berkshire Hathaway group last week in a deal worth $9.7bn (€7.1bn)
Vaccine adverse events linked to virus disrupting ingredient
19-Sep-2011 By Nick Taylor
Use of deoxycholate to chemically disrupt influenza viruses during vaccine manufacture could be linked to adverse reactions in children, a journal reports.
FDA asks for powers to stop another heparin-like crisis
15-Sep-2011 By Nick Taylor
The FDA needs additional powers to update its “antiquated, domestically-focused statute” and end the “competitive advantage of non-compliance”, an agency official said.
Lonza MA plant sent FDA GMP warning letter about Eisai API
14-Sep-2011 By Nick Taylor
The FDA has sent a warning letter to Lonza’s Hopkinton, MA plant after inspectors found faults with how it produces an oncology API for Eisai.
Biocon building Malaysia plant to serve Pfizer insulin deal
14-Sep-2011 By Nick Taylor
Biocon has begun work on the Malaysian biopharm plant that will serve its deal with Pfizer, and is now providing Lipitor ingredients.
Albemarle to hike generic API prices on regulatory costs
14-Sep-2011 By Gareth Macdonald
Albemarle says it will increase what it charges for generic APIs from next month, citing increasing regulatory and testing costs as the main reasons for the hike.
Lonza and Fosun strike up joint venture in Shanghai
12-Sep-2011
Lonza Group and Fosun Pharmaceuticals will pump $15.6m (100m yuan) into a joint venture in the Zhangjiang High-Tech Industry Zone, China.
Lanxess set to increase thionyl chloride production in Indian facility
12-Sep-2011 By Natalie Morrison
Lanxess have begun plans to increase its production of thionyl chloride by 20 per cent at its plant in Nagda, India.