Excipients, raw materials and intermediates

update

BASF unveils R&D realignment plan, citing drug excipients as important

29-Mar-2012 By Gareth Macdonald

BASF has announced plans to restructure its R&D operations, citing solubility enhancing excipients as an opportunity for growth.

FDA hits two Mexican firms with GMP warning letters

28-Mar-2012 By Nick Taylor

The FDA has hit two Mexican companies with GMP warning letters six months after inspectors visited the country.

Novasep to invest in purification-based manufacturing; opens China plant

27-Mar-2012 By Gareth Macdonald

Novasep says it may invest in active pharmaceutical ingredients (API) bioproduction and purification technology citing growing industry demand.

FDA keeps estimate of online facility registration time burden

26-Mar-2012 By Nick Taylor

The US FDA is keeping its estimate of the burden imposed by electronic facility registration despite some industry opposition.

Selecting formulation early cuts time to market, says Formac

21-Mar-2012 By Natalie Morrison

Formac Pharmaceuticals and WR Grace say their silica platform can improve the formulation selection process for poorly soluble APIs (active pharmaceutical ingredients).

Indian dominance of CEP suspension list reflects inspection policy says EDQM

21-Mar-2012 By Gareth Macdonald

Indian API manufacturers may dominate the list of companies that have had CEPs suspended this year, but that may say more about inspection policies than it does about standards outside Europe.

'Generic API manufacturers: look at drugs from launch', urges a new report

20-Mar-2012 By Natalie Morrison

Generic API (active pharmaceutical ingredient) makers should consider the off-patent potential of a drug as soon as it is launched, according to a new study by PharmaIntellect.

Sigma Aldrich shortens China supply chains with Wuxi plant

20-Mar-2012 By Gareth Macdonald

Sigma Aldrich says new packaging facility in China will shorten supply chains and help it build in an increasingly important regional market.

DEA to increase manufacturers’ controlled substance fees 30%

15-Mar-2012 By Nick Taylor

The US DEA is increasing manufacturers’ annual controlled substance fees by 30 per cent from next month.

Ranbaxy stakes claim on African drugs production market with new Moroccan plant

14-Mar-2012 By Natalie Morrison

Generics and API maker Ranbaxy has opened a plant in Casablanca, Morocco in a bid to strengthen its foothold in the “increasingly important” North African drugs market.

Paediatric safety fears targeted in EMA excipient update

12-Mar-2012 By Nick Taylor

The EMA plans to update its excipient guidelines to cover safety concerns surrounding use in children and pregnant women.

UPDATE

GSK and AstraZeneca fund NMR studies in a bid to improve manufacturing QC

08-Mar-2012 By Natalie Morrison

GlaxoSmithKline (GSK) and Astrazeneca have each funded new nuclear magnetic resonance (NMR) research at the University of Warwick, UK which could improve the QC process for drugsmakers.

Medicago and Mitsubishi team on VLP vaccine production

07-Mar-2012 By Natalie Morrison

Medicago has finalised a research collaboration agreement with Mitsubishi Tanabe Pharma Corporation for the development of new VLP vaccines.

EMA outlines herbal starting material quality requirements

06-Mar-2012 By Nick Taylor

The EMA wants manufacturers using herbal starting materials to assess the substances’ initial and post-processing contaminant profile.

FDA proposes banning DBP & DEHP excipients over tox fears

06-Mar-2012 By Nick Taylor

The US FDA is asking manufacturers to reformulate products containing DBP and DEHP excipients to cut the risk of toxicity.

Danadams issues wake-up call to Ghanaian government: “Make more drugs locally”

05-Mar-2012 By Natalie Morrison

Danadams' CEO Yaw Adu Gyamfi will tomorrow meet with the Ghanaian Government urging them to establish a drugs fund which will see more meds manufacturing in the country.

FDA guidance on API-excipient co-crystals unnecessary; Amgen

05-Mar-2012 By Nick Taylor

Amgen has called FDA draft guidance on API-excipient co-crystals unnecessary in its written response to the Agency.

FDA raises sprinkled drug bead size after big pharma criticism

01-Mar-2012 By Nick Taylor

The FDA has raised its limit on the bead size for drugs delivered by sprinkling after big pharma firms criticised its draft guidance.

UN cracks down on internet drugs fraudsters

01-Mar-2012 By Natalie Morrison

The UN has urged Governments to crack down on the growing number of fake drugs being sold online.

EMA calls for companies to trace their heparin to slaughterhouses

28-Feb-2012 By Nick Taylor

Marketing applications for heparin should cover traceability from slaughterhouses and other details of sourcing porcine mucosa, the EMA said.

FDA posts guidance on Phase I CMC for live biotherapeutics

27-Feb-2012 By Nick Taylor

The US FDA has published final guidance on the CMC data needed to support early phase trials of live biotherapeutics.

FDA guidance aims to stop drug shortages using supply alerts

23-Feb-2012 By Nick Taylor

The US FDA has published draft guidance on drug shortages to clarify when and how manufacturers should report possible supply disruptions.

update

BASF hikes EOA prices again

22-Feb-2012 By Gareth Macdonald

BASF has increased its European prices for ethanolamines (EOA) for the third time in as many months.

FDA allows temporary import of Sun’s Doxil alt to ease shortage

22-Feb-2012 By Nick Taylor

The US FDA is allowing Sun Pharma to import a version of Doxil to ease the drug shortage created by manufacturing failings at Ben Venue.

Job cuts a factor in calculating GMP compliance risk; PIC/S

21-Feb-2012 By Nick Taylor

Regulators should consider the impact of job cuts at manufacturing sites when drafting a risk-based GMP inspection plan, PIC/S said.

Abbott's extends in Sligo ready for its new API line

21-Feb-2012 By Natalie Morrison

Abbott Laboratories will pump €85m ($113m) into the expansion of its API production plant in Sligo, Ireland, in preparation of the launch of its pipeline products.

MHRA suspends license of Teva generic over dissolution fears

20-Feb-2012 By Nick Taylor

The MHRA has suspended the license for a Teva generic over suggestions its dissolution rate could affect interchangeability.

Lonza denies completion of South African API plant deal

15-Feb-2012 By Natalie Morrison

Lonza has denied reports it has signed a deal with the South African government to build a $210m (€159m) API plant, saying it is merely “in discussions” over plans.

FDA warning letter asks Merck KGaA to investigate all its sites

15-Feb-2012 By Nick Taylor

The US FDA expects Merck KGaA to do a “comprehensive and global assessment” of its sites after sending a warning letter to three plants.

FDA calls for audits of heparin suppliers in draft guidance

14-Feb-2012 By Nick Taylor

The FDA is asking companies to audit heparin suppliers in draft guidance intended to stop a repeat of the 2008 contamination.

AMPAC sales jump 50% on return of antiviral revenues

09-Feb-2012 By Nick Taylor

AMPAC Fine Chemicals posted a 50 per cent jump in revenues after the return of sales from its antiviral business.

Cambrex on takeover hunt amid pharma fine chem consolidation

08-Feb-2012 By Nick Taylor

Cambrex expects fine chemical consolidation to continue this year and is being “proactive” in its hunt for takeover targets.

Rx-360 warns Pharmas of potential L-Arginine shortage

08-Feb-2012

Pharma supply chain consortium Rx-360 has advised drugmakers to check their L-Arginine stocks, warning that a recent surge in demand could limit supplies.

GSK aims to cut time to clinic with excipient-free compression

08-Feb-2012 By Nick Taylor

GSK is developing tablets it can compress without excipients to cut the time taken to reach the clinic by up to nine months.

Shanghai Pharmaceuticals buys major stake in special API maker

07-Feb-2012 By Natalie Morrison

Shanghai Pharmaceuticals has bought a 70 per cent stake in ingredients developer and manufacturer Changzhou Kony Pharm in a bid to boost its standing in the API market.

Australia mulls chemical supply chain actions to stop terrorism

07-Feb-2012 By Nick Taylor

Australia is considering steps to stop chemicals used in drug manufacturing from being diverted by terrorists to make explosives.

US act aims to end shortages by speeding post-approval changes

06-Feb-2012 By Nick Taylor

A US drug shortages act aims to make drug production more efficient by quickening review of post-approval manufacturing changes.

UPDATE

Tamil Nadu will be next manufacturing hit if makers meet WHO standards, says IDMA

06-Feb-2012 By Natalie Morrison

The Indian Drug Manufacturers Association (IDMA) plans to amp up pharma business in Tamil Nadu by helping more companies meet WHO production standards.

EU plan to add APIs to pollutant watch list could raise costs

02-Feb-2012 By Nick Taylor

European Commission plans to add three APIs to its list of water polluting chemicals could result in costs to pharmaceutical companies.

Kerry to build new cell culture lab for biopharmas

01-Feb-2012 By Gareth Macdonald

Food ingredients and flavours firm Kerry Group is to build a cell culture and media development lab for the pharmaceutical biomanufacuturing sector.

DSM to sell APIs made by Indoco Remedies

31-Jan-2012

DSM Pharmaceutical Products (DPP) will sell APIs made by Indian manufacturer Indoco Remedies in a new agreement that fits with its global expansion plan.