Bulk ingredients

update

CordenPharma Owner Buys Belgian Peptide Firm to Boost API business

29-Aug-2013 By Gareth Macdonald

ICIG will buy the Belgian operation of peptide maker Peptisyntha SA from Solvay to expand its recently rejigged contract API business.

Garmen to Make Podophyllotoxin Extract Adva-27a for Sunshine BioPharma

27-Aug-2013

Canadian contract manufacturing and testing firm Garmen Laboratories will be acquired by Cancer drug developer Advanomics Corp in a deal announced today.

Amarin Asks US FDA to OK Novasep as Vascepa API Supplier

27-Aug-2013 By Gareth Macdonald

Amarin wants US regulatory approval to add Novasep to the list of APIs suppliers for its fish oil heart pill, Vascepa.

Siegfried Higher on Controlled Substances, China plant on track

26-Aug-2013 By Gareth Macdonald

Higher demand for methadone, buprenorphine and opiates coupled with the positive impact of a recent acquisition drove first half growth at Swiss supplier Siegfried.

update

Fabbrica Italiana Sintetici Expands IMCD Promotion Deal

26-Aug-2013

IMCD Group will promote APIs made by Italian firm FIS in territories in Eastern Europe and the Southern hemisphere under a new agreement. 

ScinoPharm and Sundia MediTech Team for Big Pharmas Outsourcing to China

07-Aug-2013

ScinoPharm and Sundia MediTech have teamed up to try and win business from international drugmakers that - they say - want to simplify outsourcing to China.

Lonza Licenses Expression Tech to Second Firm in Two Weeks

07-Aug-2013 By Gareth Macdonald

Lonza has granted access to its potency boosting expression system to antibody developer Sorrento Therapeutics just days after a signing a similar deal with Pfizer.

API, Generic Drug Facilities Hit With US FDA Fee Hikes for 2014

06-Aug-2013 By Zachary Brennan

US and foreign generic drug manufacturers will see a more than $40,000 increase in US FDA facility fees for 2014, while API manufacturers will see a more than $8,000 increase.

Sanofi to Manufacture Vivus' ED API

05-Aug-2013 By Dan Stanton

Vivus has selected Sanofi Chimie to manufacture the API for its ED drug due to price and capacity, the company says.

Burlington Re-inspection Earns AMRI New US FDA Form 483

23-Jul-2013 By Gareth Macdonald

The US FDA has issued AMRI with another Form 483 for its manufacturing facility in Burlington, Massachusetts.

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.

Saltigo's Daiichi Sankyo Deal, a Boon for Leverkusen Site?

09-Jul-2013

Saltigo has won a manufacturing contract with Daiichi Sankyo under it which it will provide custom synthesis services for one of the Japanese drugmaker’s pipeline candidates.

EFPIA Does Not Expect Drug Shortages Due to New EU API Regs

02-Jul-2013 By Gareth Macdonald

Industry group EFPIA does not expect the new EU API import regulations to cause drug shortages but says the next 6-months will be critical.

Aspen Acquires Merck’s Dutch API Plant for $1B

01-Jul-2013 By Zachary Brennan

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.

Insulin CMO Sued by US City Over Failed Manufacturing Plant

17-Jun-2013

A US CMO that promised to make cost-effective, generic insulin has been sued by the city where it planned to set up a manufacturing plant. 

B-I says Chinese JV Could Elevate Domestic Manufacturing Industry

10-Jun-2013 By Dan Stanton

Boehringer Ingelheim will build a biomanufacturing facility in Shanghai in a strategic alliance designed to cater for Pharmas nervous about setting up plants in China.

Contract Manufacturer Acquires Pfizer’s Tennessee Plant

30-May-2013 By Zachary Brennan

UPM Pharmaceuticals will acquire Pfizer’s commercial manufacturing facility in Bristol, Tennessee to scale up its capacity as a contract manufacturer.

Possible API Contamination at Chinese CMO Leads to Canadian Recalls

22-May-2013 By Dan Stanton

Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.

SCM Named Commercial Supplier in Varisolve NDA

14-May-2013 By Gareth Macdonald

Varicose veins could prove to be a big revenue stream for UK CMO SCM Pharma which has been named as commercial supplier for BTG’s candidate treatment, Varisolve.

Aesica Accesses Atom-Efficient Amide Tech in Academic Accord

14-May-2013 By Gareth Macdonald

Making amide bonds may be greener and cheaper in the future according to Aesica, which has partnered with UK scientists to commercialize a new synthesis technique.

Large Scale Manufacturing Drives AMRI Q1 Revenue Uptick

14-May-2013 By Zachary Brennan

Large scale manufacturing contract revenue in the first quarter of 2013 increased 14% over the same quarter in 2012 as AMRI (Albany Medical Research Inc.) saw an 11% increase in overall revenue. 

BASF and Chemport Get US OK as Amarin API Suppliers

07-May-2013 By Gareth Macdonald

API makers Chemport and BASF have been cleared by US regulators to supply Amarin with omega-3 for its heart drug Vascepa.

US FDA Rebukes Alexion APIs, Pfizer Italian Subsidiary in Warning Letters

10-Apr-2013 By Zachary Brennan

The manufacturing sites of Alexion Pharmaceuticals and Italy-based Wyeth Lederle S.p.A  were cited in FDA warning letters for cGMP (current good manufacturing practice) violations in their production of APIs and finished pharmaceuticals, respectively.

India, China Fall Behind in Preparation for New EU API Rules

08-Apr-2013 By Zachary Brennan

China and India have more work to do to confirm their API manufacturing sites comply with EU GMP requirements, according to the European Commission’s Pharmaceutical Committee.

GSK to Expand Supplier "Risk Mapping" in 2013

03-Apr-2013 By Gareth Macdonald

GSK will conduct more audits of key suppliers in 2013 as part of a ‘risk mapping’ effort to safeguard its £9bn ($13bn) a year outsourcing spend.

Cook Pharmica OKed by US FDA Without Inspection

25-Mar-2013

The US FDA has waived normal pre-approval inspection requirements and cleared CMO Cook Pharmica to make an injectable drug that is currently in short supply.  

Private Equity Backs Micron Technologies Management Buyout

20-Mar-2013 By Gareth Macdonald

US-based particle engineering services frim Micron Technologies has been acquired in a private-equity backed management buyout. 

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.

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.

Canadian CMO Hit with FDA Warning Letter for cGMP Violations

07-Mar-2013 By Zachary Brennan

A Canadian subsidiary of India’s largest CMO (contract manufacturing organization) was cited by the US FDA for failing to investigate rejected batches of product or implement further preventive actions.

Ajinomoto Wins ‘Top-Tier’ Pharma Licensee; Plans to Buy Althea Technologies

06-Mar-2013 By Gareth Macdonald

Ajinomoto says its flexible approach to tech licensing differs from rivals who are more focused on locking customers into manufacturing services contracts.

update

SAFC Expands Manufacturing Capacity to Meet Growing EU Needs

05-Mar-2013 By Zachary Brennan

SAFC will expand manufacturing capacity at its facility in Irvine, Scotland, to include large-scale production of bulk dry powder media and reagents to save EU clients’ money in shipment costs.

Albemarle Expands Manufacturing Capacity in Pennsylvania

27-Feb-2013 By Zachary Brennan

Albemarle is adding new capacity at its manufacturing facility in Pennsylvania with a $30 million expansion.

BASF says Bend Accord Targets Different Chemistries than Dow deal

25-Feb-2013 By Gareth Macdonald

Bend Research has partnered with its second chemistry major in six months, teaming up with BASF to develop bioavailability-boosting excipients.

Lonza wins $7m US NIH stem cell contract

21-Feb-2013

Lonza has won a second US NIH contract to manufacture stem cells for medical research.

Collaboration With Britest Already Paying Off Says Aesica

21-Feb-2013 By Gareth Macdonald

UK CMO Aesica claims its partnership with process innovation group Britest has already increased capacity without capital investment. 

ProBioGen in ADCC Enhancement License Deal with Big Pharma

20-Feb-2013 By Dan Stanton

CMO ProBioGen says its GlymaxX ADCC antibody enhancement technology can be adapted to any biomanufacturing cell line and will attract both Big and Small Pharma.

Dispatches from Informex

Intermediate CMOs Shift Attention to Nucleoside Development

20-Feb-2013 By Zachary Brennan

CMOs (contract manufacturing organizations) developing pharmaceutical intermediates have shifted their focus to complex nucleosides, peptides and carbohydrates over the last five years, an expert says.

Biocatalysis Becoming Big Business for CMOs

19-Feb-2013

Biocatalysis is emerging as a hot topic for CMOs in 2013 with AMRI, Almac and DSM all citing drug industry demand as the driver for recent collaborations.

AMRI Deal a Catalyst for Pharma Growth says Codexis

14-Feb-2013 By Gareth Macdonald

AMRI has teamed up with biocatalysis firm Codexis to develop cheaper, faster and greener ways of manufacturing APIs.

BMS Manufactures for Now as Reckitt Benckiser Enters Latin America

13-Feb-2013 By Dan Stanton

Bristol-Myers Squibb (B-MS) will continue to make the OTCs it licensed to Reckitt Benckiser for the time being but will hand over manufacturing if the UK drugmaker buys them outright.

Beximco starts shipping Formulations to Europe

12-Feb-2013 By Dan Stanton

Formulations of two ophthalmic drugs have become the first exports to Europe from Bangladeshi company Beximco as they seek to expand into the EU market.

Johnson Matthey to optimise API biz; Fine Chem forecasts roundup

11-Feb-2013 By Gareth Macdonald

in-Pharmatechnologist.com presents a roundup of news in the fine chemicals sector, beginning with Johnson Matthey which has started a review of its active pharmaceutical ingredient (API) business after competition in the UK impacted its third quarter...

Update

Teva to Sell Californian Plant as Part of Cost-Cutting Initiative

11-Feb-2013 By Dan Stanton

Teva says the offloading of its Californian manufacturing facility is part of cost-cutting plans designed to save $2bn (€1.5bn). in the next few years.

Lonza rejigs ops and says more changes are to follow

05-Feb-2013 By Gareth Macdonald

Lonza has reorganised its operations into two new divisions – Pharma and Specialty ingredients – and says more changes are on the way.

Lonza hints at manufacturing cuts

31-Jan-2013 By Dan Stanton

Lonza says it will “move from a product-oriented to a market-oriented organisation” suggesting a restructuring of its manufacturing division is on the cards.

update

US asks for exemption from EU API import laws

28-Jan-2013 By Gareth Macdonald

The US wants exemption from new European Union import rules for active pharmaceutical ingredients (APIs) and says such status would cut manufacturers' admin and help prevent drug shortages.

update

SFDA yet to publish excipient list as implementation date for GMP nears

22-Jan-2013 By Gareth Macdonald

Chinese regulators have just 11 days left to define which excipients must be licensed or require DMFs under new quality regulations due to be introduced next month.

ADC Bio open to antibody drug conjugate collaborations and CMO takovers

21-Jan-2013 By Gareth Macdonald

ADC Biotechnology has secured funding to take its cost-cutting antibody drug conjugate (ADC) tech to market and says pharma demand will drive partnerships and maybe even attract CMO takeover bids.

Updated

Lonza to Evaluate BaroFold’s Protein Refolding Technology

21-Jan-2013 By Zachary Brennan

Lonza has agreed to evaluate BaroFold’s high-pressure refolding technology for difficult to express microbial products expressed as inclusion bodies.