Excipients, raw materials and intermediates

Capsugel to Buy Bend Research to Expand Bioavailability Offering

05-Sep-2013 By Gareth Macdonald

Capsugel will buy Bend Research to expand its dosage form solutions (DFS) business in a deal announced earlier today.

EU’s CHMP Decides to Wait on ICH for Metal Impurities Guideline

04-Sep-2013 By Zachary Brennan

The EU’s CHMP(Committee for Medicinal Products for Human Use) will delay the application of a guideline that would set limits on metal catalysts or metal reagent residues until the ICH finalizes its own guideline on the issue.

Aoxing's Sales Soar After "Capsule Fiasco" Almost Ruined Company

27-Aug-2013 By Dan Stanton

Aoxing Pharmaceuticals reported increased sales and lower operating expenses for Q2 2013 one year on from the chromatin-tainted gelatin scandal that led to suspension of sales by China’s regulators.

Codexis Denies Expression System Licence Breach

19-Aug-2013 By Gareth Macdonald

Codexis has denied breaching its licensing deal with Dyadic International and says losing rights to the C1 fungal expression system would hit its CodeXyme business hard.

ICH Opens Elemental Impurities Guideline for Consultation

12-Aug-2013

The ICH last week sent its guideline on elemental impurities in drug products to the regulatory authorities in the US, EU and Japan for consultation.

PTI to Expand Missouri Manufacturing Facility with $5M Investment

08-Aug-2013 By Zachary Brennan

CMO Pharma Tech Industries (PTI) will invest more than $5M to expand its production facility in Union, Missouri, which makes ingestible powders.

Thermo Fisher Opens First Dry Powder Media Plant in Singapore

07-Aug-2013 By Dan Stanton

Growing demand amongst biomanufacturers has prompted Thermo Fisher to open the first dry powder media (DPM) production plant in Singapore.

Aug. Hedinger First Excipient Supplier to Pass Excipact

07-Aug-2013

German excipient maker Aug. Hedinger GmbH & Co. KG has confirmed it passed an excipact audit conducted in earlier this year.

Excipients Boost Efficacy in Oral Delivery Platform, says Enteris

06-Aug-2013 By Dan Stanton

Enteris has acquired an oral drug delivery platform from Unigene Laboratories and says the excipients used can increase solubility and absorption for both peptides and small molecules.

EMD Millipore says Formal Excipient GMP would Level Playing Field

05-Aug-2013 By Gareth Macdonald

EMD Millipore says while voluntary excipient quality schemes are step in the right direction, formal GMP and enforcement would create a level playing field.

IMCD Buys Australian Ingredients Distributor

01-Aug-2013

IMCD has bought Sydney-based drug and food ingredient distributor Capitol Ingredients Australia to increase its access to local markets.

Novozymes' HA Delays API Release and Boosts Drug Half-Life

01-Aug-2013 By Gareth Macdonald

Delays are annoying. Whether you are a journalist trying to ask a few quick questions without involving teams of public relations people or a driver stuck in a traffic jam, delays are normally a bad thing.

US FDA Amends Draft Guidance Documents List for 2013

31-Jul-2013 By Zachary Brennan

The US FDA has amended the list of draft guidance documents it expects to release for the rest of the year with two new guidance topics, one deleted guidance and a few other hotly-anticipated documents still to come.

Correction

EMD Millipore Passes Excipient Certification Scheme

31-Jul-2013 By Gareth Macdonald

EMD Millipore has become the first major drug excipient supplier to pass IPEC Federation’s Excipact certification scheme.

Codexis and Purolite Team on Immobilised Enzymes for Drugmakers

30-Jul-2013 By Gareth Macdonald

Codexis and Purolite have teamed up to create immobilized enzymes they say can speed up active pharmaceutical ingredient (API) development.

Catalent Completes Chinese Softgel Acquisition

30-Jul-2013

Catalent has completed the purchase of a Chinese softgel firm following regulatory approval.

New Particle Tech May Let Formulators Cut Out Costly Lactose says Pulmatrix

24-Jul-2013 By Gareth Macdonald

Dry powder inhaler firms may soon be able to eliminate lactose from formulations if a new high dispersibility particle production platform is successful in trials.

US Debates Dropping Duty for Drug Intermediates Imports

22-Jul-2013 By Gareth Macdonald

Import duties on some pharma intermediates could be suspended temporarily under legislation being debated in the US House of Representatives.

Albemarle's Fine Chem Sales Drop in Q2

18-Jul-2013 By Gareth Macdonald

Albemarle says pricing pressure, lower volumes and reduced capacity utilisation negatively impacted its fine chemicals business in the second quarter.

China API Firms Knowledge of EU CEPs "Good on Paper" says Audit Firm

16-Jul-2013 By Gareth Macdonald

Chinese understanding of European CEPs is good, but some manufacturers are still unclear on the related obligations and requirements according to auditing firm, blue inspection body.

South Africa Joins European Pharmacopoeia as Observer

16-Jul-2013 By Zachary Brennan

South Africa’s decision to join the European Pharmacopeia as an observer comes as the country looks to obtain more expertise on quality standards.

Dry Syrup Formulation Aims to Ease Alzheimer’s Drug’s Delivery

08-Jul-2013 By Zachary Brennan

A new high-intensity sweetener-based reformulation approach could improve compliance among Alzheimer’s patients and make dose adjustment easier says Tokyo drugmaker, Eisai.

India’s CDSCO Sets New Deadline for Drug Manufacturers to Comply with Law

02-Jul-2013 By Zachary Brennan

India’s top drug regulator is calling on manufacturers that received unauthorized drug approvals and manufacturing licenses to prove the safety and efficacy of their marketed drugs by August 31.

It Had To Be Yew? Not So Says Phyton With New Docetaxel CEP

19-Jun-2013 By Gareth Macdonald

Phyton Biotech has received European approval for a version the cancer drug API docetaxel whose production does not rely on the scarce yew tree extract used in traditional manufacturing methods.

EC welcomes list of Indian API suppliers with ‘written confirmation’

13-Jun-2013 By Gareth Macdonald

The European Commission has welcomed the publication of the list of Indian API makers issued with “written confirmations” of quality by the CDSCO.

Some China API Firms Wont Have 'Written Confirmations' by July says blue inspection body

12-Jun-2013 By Gareth Macdonald

Some Chinese firms wont have the 'written confirmations' required to ship APIs to the EU from July according to the German audit firm tasked with helping manufacturers prepare by Beijing industry group, CCCMHPIE.

Manufacturing Restarts at Teva API Plant After Deadly Explosion

05-Jun-2013 By Dan Stanton

Limited operations have recommenced at a Teva API facility in Israel after a blast that killed one and injured over 30.

USP Delays Deadline for Industry to Comply With Elemental Impurity Standards

03-Jun-2013 By Zachary Brennan

USP has decided to delay the implementation of two general chapters on elemental impurities until ICH has further established its own impurity testing requirements.

3M Prepared as Final Two CFC-Based Inhalers to be Phased Out

30-May-2013 By Dan Stanton

3M says it has cooperated with the FDA and invested in its facilities in preparation of the phase-out of CFC containing metered dose inhalers (MDIs).

EMA Biosimilars Draft: Non-EU Reference Avoids Clinical Trial Repeats

21-May-2013 By Dan Stanton

The EMA (European Medicines Agency) has released draft guidelines on biosimilars allowing non-EEA comparators to be used in limited circumstances.

Coalition Calls for Science-Based Approach to Elemental Impurity Testing

15-May-2013 By Zachary Brennan

Differences in elemental impurity standards being developed separately by the US Pharmacopeia and ICH could mean costly reformulations according to a pharmaceutical, API and excipient industry coalition.

EMA Seeks to Revise Some Phthalate Limits in Excipients

08-May-2013 By Zachary Brennan

The EMA may recommend new daily exposure limits for some phthalates as animal data have shown they can cause negative reproductive and development effects, according to a new draft guideline.

Dispatches from Excipient Fest in Baltimore

Brazil’s Anvisa to Publish Revised Excipient GMP Guideline

06-May-2013 By Zachary Brennan

Revised excipient guidelines expected from Brazilian regulator Anvisa this year will reduce confusion and further align standards with those in the US and EU says an industry expert.

Dispatches from Excipient Fest in Baltimore - UPDATE

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients

02-May-2013 By Zachary Brennan

As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and excipients, questions still remain on whether the manufacturers will be able to comply with the looming requirements.

Dispatches from Excipient Fest in Baltimore

China Looks to Tighten Excipient Regulations with Limited Resources

02-May-2013 By Zachary Brennan

China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have added another layer of safety requirements but challenges remain for the regulators in ensuring compliance, experts say.

Prof Says Knowing How to Handle Dangerous Reagents is Key

22-Apr-2013 By Gareth Macdonald

The inventor of a reagent recently found to be highly explosive says many drug production chemicals may have similar profiles and that knowing how to handle them is the key.

update

Key Drugmaking Reagent As Inflammable as Gunpowder Warns Novasep

16-Apr-2013 By Gareth Macdonald

Novasep has discovered that the drug manufacturing regent Togni II is highly explosive and as inflammable as gunpowder.

BD Forms Pharmaceutical Wing with New Prefilled Generic Injectables

28-Mar-2013 By Dan Stanton

BD says a brand new facility and sustainable pricing will allow the company to compete as it enters the generics market following FDA approval of its first injectable drug.

Updated Excipient Package User Guide Aims to Reduce Redundancy for Suppliers

27-Mar-2013 By Zachary Brennan

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.

API Corp. Invests in Neuland for More API, Intermediate Manufacturing

14-Mar-2013

Tokyo-based API Corporation, a unit of Mitsubishi Chemical Holdings Group, is making an investment in API and pharmaceutical manufacturer Neuland Laboratories’ facilities.

Catalent Focuses on Softgel in One of Two Chinese Ventures

13-Mar-2013 By Dan Stanton

Catalent says it has acquired a Chinese softgel producer to expand its drug delivery offerings and expects more investments to come as part of a two-pronged plan into China.

Patheon to Shutter Manufacturing Plant as Part of Banner Integration

12-Mar-2013 By Dan Stanton

Patheon says the shuttering of one of Banner’s manufacturing sites is necessary in integrating the recent acquisition into its global business structure.

Update

Ashland to Expand Delaware Formulation and Contract Manufacturing

11-Mar-2013 By Dan Stanton

Ashland says it is expanding its contract manufacturing business in order to offer its customers greater scope in drug solubilization.

EMA proposes virus testing for food sector-derived trypsin used in drugmaking

06-Mar-2013

Food industry controls do not ensure porcine trypsin is virus-free according to the EMA, which proposes testing procedures for drugmakers which use the reagent in a new consultation document.

update

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