QA/QC

WHO adds gatifloxacin to prequalification list to encourage API manufacturers

17-Oct-2016 By Gareth Macdonald

The WHO has added side-effect heavy, TB drug ingredient gatifloxacin to its prequalification list to encourage production.

FDA and CDC links B. cepacia outbreak to contamination at PharmaTech

13-Oct-2016 By Dan Stanton

The US FDA has found a direct link between contaminated water at CMO PharmaTech and a multistate B. cepacia outbreak.

Pfizer on CMOs: $180bn is at stake so being first-to-market is critical

13-Oct-2016 By Dan Stanton

With the top 500 molecules in development having a commercial potential of $180bn by 2022, being first-to-market is critical says Pfizer.

Online API platform could help secure supply chain, says consultancy firm

12-Oct-2016 By Dan Stanton

Finding and validating an ingredient supplier can take up to 26 weeks says consultancy firm Rephine, which hopes to address the burden through an online API sourcing platform.

Aralez buys rights to AZ heart drug; encouraged by generic quality issues

10-Oct-2016 By Dan Stanton

AstraZeneca will supply Toprol-XL to Aralez Pharmaceuticals Trading for at least 10 years after selling the US rights to the off-patent beta blocker for $175m.

US FDA rejects Nicox's topical Zyrtec rival over concerns about API supplier

10-Oct-2016 By Gareth Macdonald

The US FDA has rejected an eye drug developed by Nicox SA as a result of manufacturing problems at the firm’s API supplier.

Mappel doesn't want to supply US after warning letter

07-Oct-2016 By Gareth Macdonald

Mappel Indústria de Embalagens says it did not know the US would regulate the dermacosmetic products made at its Sao Paulo plant as OTC drugs after FDA warning.

Nippon staff formed barrier to block QC lab inspection says US FDA

07-Oct-2016 By Gareth Macdonald

Nippon Fine Chemical staff formed a human barricade to prevent a US FDA team inspecting a quality control laboratory at its site in Takasago City, Japan according to a warning letter published this week.

Dispatches from CPhI

APIC concerned about EU API import rules

06-Oct-2016 By Gareth Macdonald

European Union API import rules do not ensure ingredients shipped to Europe are of appropriate quality according to APIC board member, Marieke Van Dalen.

DSP: "quality mark" would engage patient choice in fight against antimicrobial resistance

04-Oct-2016 By Gareth Macdonald

A “quality mark” for firms that source from green API suppliers would add patient choice element to fight against antimicrobial resistance according to DSM Sinochem Pharmaceuticals.

US FDA: Cheng Fong Chemical must do more to investigate complaints

28-Sep-2016 By Gareth Macdonald

Cheng Fong Chemical has addressed problems at its Taoyuan City plant but still needs to identify the source of foreign matter found in its APIs according to the US FDA.

China made APIs shipped to fake Viagra lab via UK say Polish police

28-Sep-2016 By Gareth Macdonald

Viagra counterfeiters in Poland imported APIs made in China via the UK, Greece and Romania according to police who shut down a major manufacturing operation last week.

DSP: Pharmas must be open about API suppliers to fight antibiotic resistance

26-Sep-2016 By Gareth Macdonald

Drug companies need to me more open about their API suppliers to help fight the spread of antimicrobial resistance (AMR) according to DSM Sinochem Pharmaceuticals.

Analytik Jena sets up joint application center

26-Sep-2016 By Joseph James Whitworth

Analytik Jena and the Fresenius University of Applied Sciences are to create a joint application center for customers for teaching and research.

Urine derived clot busters do not pose Zika risk says EMA

22-Sep-2016 By Gareth Macdonald

Clot busting drugs derived from human urine are no more likely to be contaminated with Zika virus than other medicines according to research by the EMA.

Moderna to spend $110m on mRNA therapeutics manufacturing plant

21-Sep-2016 By Gareth Macdonald

Moderna Therapeutics has announced plans for a $110m (€98m) API manufacturing facility for its pipeline of mRNA therapeutics.

US FDA warns API firm Hebei Yuxing Bio-Engineering

21-Sep-2016 By Gareth Macdonald

Banned API firm Hebei Yuxing Bio-Engineering has had a microbial contamination problem at its plant since 2013 according to the US FDA.

Johnson Matthey's refurbished Annan API plant passes MHRA GMP inspection

20-Sep-2016 By Gareth Macdonald

The UK MHRA has awarded Johnson Matthey’s API facility in Scotland a GMP certificate.

Pii faces EU ban following GMP issues at Maryland facilities

19-Sep-2016 By Dan Stanton

The EMA has recommended a European ban of all non-critical drugs made by US CMO Pharmaceutics International Inc (Pii).

Bayer committed to pharma R&D and CapEx despite planned Monsanto buy

15-Sep-2016 By Gareth Macdonald

Bayer has said it will not cut drug R&D or manufacturing investment as a result of its planned acquisition of Monsanto.

Teva months from restarting production at Hungary plant banned by US FDA

15-Sep-2016 By Gareth Macdonald

Teva expects to restart drug manufacturing at the Hungarian plant under US import alert in the next few months.

Indoco Remedies stresses that Form 483s are not data integrity related

14-Sep-2016 By Gareth Macdonald

Indoco Remedies says problems the US FDA identified at an ophthalmic and injectable drug plant in Goa, India last month are “correctable.”

Novo Nordisk recalls GlucaGen HypoKit in US after error at syringe supplier

13-Sep-2016 By Gareth Macdonald

Novo Nordisk has recalled six lots of its GlucaGen HypoKit pen in the US after customers in Europe complained of detached needles.

'Chipped paint' and 'flying insects,' FDA slams two Chinese API plants

01-Sep-2016 By Dan Stanton

Xinxiang Tuoxin Biochemical has received a US FDA warning letter after manufacturing equipment at two API facilities were found to be in a state of disrepair.

India turns to certification in pharma manufacturing quality drive

01-Sep-2016 By Phil Taylor

India's government has launched a certification programme aimed at tightening up quality standards in its domestic drug industry.

Out-of-spec assay drove Teva to recall antibiotic from Canadian plant

31-Aug-2016 By Staff reporter

An out-of-specification assay result resulted in Teva recalling over 50,000 bottles of the antibiotic amoxicillin made at a facility in Canada.

Quality issues at ex-Sun Pharma plant land Frontida with US FDA warning

29-Aug-2016 By Dan Stanton

The Pennsylvania plant released 27 lots of clonidine HCl tablets containing potentially contaminated active pharmaceutical ingredients (APIs), among several violations of cGMP the Agency said.

API firm Unimark Remedies warned by US FDA about Indian plants

25-Aug-2016 By Gareth Macdonald

The US FDA has warned API manufacturer Unimark Remedies about unsanitary conditions at its facility in Vapi and Bavla in India.

Sagent recalls second lot of antibiotic made by Astral SteriTech after rust found in vial

23-Aug-2016 By Gareth Macdonald

Sagent Pharmaceuticals has recalled another lot of its injectable penicillin in the US after a customer found rust in a vial of the drug.

Cost pressures turning pharma towards automation tech, says Zenith

23-Aug-2016 By Dan Stanton

Increased cost pressures and a shift to biologics manufacturing are driving demand for automation technologies, says Zenith which is opening two offices in the US.

Actavis pulls Patheon-made diabetes pills after out-of-spec tests

22-Aug-2016 By Gareth Macdonald

Actavis has recalled five lots of a diabetes drug glipizide made by Patheon after tests revealed that the tablets did not meet specifications.

UK MHRA strips Pfizer-owned India antibiotics plant of GMP certificate

22-Aug-2016 By Gareth Macdonald

An Indian facility owned by Pfizer’s Hospira unit has been banned from supplying some drugs to the EU after MHRA inspectors found breaches of manufacturing regulations.

US FDA wants to reclassify co-crystals to ease regulatory burden

18-Aug-2016 By Gareth Macdonald

The US FDA wants to reclassify pharmaceutical co-crystals as solvates rather than intermediates to reduce the regulatory burden on manufacturers that work with them.

Problem at UK API plant not Italian site says GSK

GSK API "issue" will limit supplies of Allergan's superbug buster Avycaz

17-Aug-2016 By Gareth Macdonald

An issue at a GSK API manufacturing site will limit supplies of the superbug busting antibiotic Avycaz for the next six months according to drug manufacturer Allergan.

Pfizer vancomycin supplier Zhejiang Medicine warned by US FDA

17-Aug-2016 By Gareth Macdonald

Pfizer supplier Zhejiang Medicine Co. should quiz staff to determine the extent of data integrity deficiencies at its API plant in Xinchang, China according to the US FDA.

AEMPS says Alcor's plan to fix problems at Spain plant is insufficient

15-Aug-2016 By Gareth Macdonald

Laboratorios Alcor SL's plan to fix problems at a manufacturing facility in Guadalajara, Spain is insufficient according to Spanish regulators.

Valeant gives six months timeline for FL plant reinspection after eye drug CRL

11-Aug-2016 By Dan Stanton

Concerns raised by the US FDA pertaining to cGMP at a Florida facility are expected to be resolved within six months, according to Valeant.

US FDA warns Concept Products for failing to fix cGMP violations at Tianjin plant

10-Aug-2016 By Staff Reporter

The US FDA has criticised Chinese manufacturer Concept Products for not fixing cGMP violations observed by inspectors who visited its manufacturing site in Tianjin.

PharmaTech expands recall of drugs made at Florida plant linked to B. cepacia outbreak

10-Aug-2016 By Gareth Macdonald

PharmaTech LLC has recalled more drugs made at the Florida plant that was linked an outbreak of B. cepacia last month.

Pfizer recalls anaesthetic made at Hospira's Rocky Mount facility

10-Aug-2016 By Gareth Macdonald

Pfizer unit Hospira has recalled one lot of the anaesthetic made at its facility in Rocky Mount, North Carolina after particulate matter was found in a vial of the drug.

Bayer recalls Kogenate lots in Spain after out of spec stability results

09-Aug-2016 By Gareth Macdonald

Bayer has recalled its injectable haemophilia drug Kogenate in Spain according to the country’s regulators.

Amikacin recalled by Teva after US shortage ends

Teva recalls injectable antibiotic in US over contamination concerns

09-Aug-2016 By Gareth Macdonald

Teva has recalled an injectable antibiotic that is one of only two products currently made at the Godollo, Hungary facility that was hit with a US import ban in May.

Pfizer halts production at Hospira India plant slammed by regulators

09-Aug-2016 By Dan Stanton

Pfizer has temporarily halted production at a former-Hospira aseptic plant in Chennai, India after regulators observed manufacturing issues during an inspection in June.

update

US FDA raises concerns about Alexion's Rhode Island Soliris facility

09-Aug-2016 By Gareth Macdonald

The US FDA has identified quality problems at a Smithfield, Rhode Island plant where Alexion makes the immunosuppressant Soliris (eculizumab) and other products.

Bangladesh Court orders 34 drug firms to halt production, again

08-Aug-2016 By staff reporter

The High Court in Bangladesh has ordered 34 firms to stop making drugs and recall products after discovering they had ignored a ban imposed in June.

Third strike for Wockhardt as API facility hit with US import alert

08-Aug-2016 By Dan Stanton

The US FDA has banned products from a third Indian manufacturing plant operated by Wockhardt.

WR Grace opens pharma-focused QC lab and predicts second half intemediates growth

08-Aug-2016 By Gareth Macdonald

W.R. Grace has opened a pharma quality control laboratory at its manufacturing facility in Albany, Oregon and predicted higher drug intermediates sales in the second half of the year.

Danish children hospitalized by super strength Inno Pharma vitamin D

04-Aug-2016 By Gareth Macdonald

Several children have been hospitalized by a vitamin D supplement made by Inno Pharma according to regulators in Denmark.

US NIH permanently halts drug production at site criticised by US FDA

04-Aug-2016 By Gareth Macdonald

The US National Institutes of Health (NIH) has permanently halted trial drug production at a site where cGMP violations were identified last year.

US FDA says Xiamen Origin Biotech lied to inspectors who visited API plant

03-Aug-2016 By Gareth Macdonald

The US FDA says Xiamen Origin Biotech Co. lied to investigators during an inspection of its API facility in Fujian in which significant deviations from cGMP were identified.