QA/QC

Mylan expands valsartan recall in US

05-Dec-2018 By Flora Southey

Mylan has requested all lots of valsartan, as well as combination amlodipine/valsartan, and valsartan/ hydrochlorothiazide tablets, be returned in the US.

US inspection protocols offer a more transparent, risk-based approach, says Recipharm

05-Dec-2018 By Flora Southey

The US FDA’s New Inspection Protocol Project represents an “improvement process step” towards a risk-based site selection model, according to the Swedish CDMO.

Five further countries join EMA-FDA mutual recognition pact

03-Dec-2018 By Ben Hargreaves

Inspections of manufacturing facilities undertaken by Belgium, Denmark, Finland, Latvia and Estonia will be recognised as valid by the US FDA.

Industry 4.0: Avoiding digitisation and modernisation ‘not an option’

30-Nov-2018 By Ben Hargreaves

If the industry wants to maintain control of manufacturing operations, it has to adopt digital technologies or face being ousted by Amazon, suggested GSK’s Pharma 4.0 director.

Aquestive receives CRL, switches API supplier over concerning ‘quality controls’

29-Nov-2018 By Ben Hargreaves

Aquestive’s NDA to the US FDA was knocked back over API issues, but the company still expects the product to be available by 2020.

Pharma Integrates

Five technologies that could disrupt pharma manufacturing

23-Nov-2018 By Ben Hargreaves

Pharma production is ‘too conservative’ and needs to ‘be bolder’ in adopting nascent technologies, or be left behind by new models, suggested one MD.

Industry invests in supply chain strategies for low-income countries

21-Nov-2018 By Ben Hargreaves

Pharma companies have improved or maintained standards for effective drug recalls, product packaging and managing supply in LMICs, according to the report.

Mylan responds to US FDA warning letter on Morgantown facility

21-Nov-2018 By Maggie Lynch

Mylan stated it is undertaking ‘comprehensive restructuring’ of the facility, after a recent warning letter issued to the company by the FDA.

Pharma Integrates

What will tip the scales towards continuous manufacturing?

20-Nov-2018 By Ben Hargreaves

A closer partnership between CDMOs and pharma companies could share the risk of innovation, suggested one pharma director.

NEWS IN BRIEF

Ardena: M&A growth fuels HQ expansion

14-Nov-2018 By Flora Southey

CDMO Ardena has moved into larger headquarters in Gent, Belgium, to “free up space for additional laboratories”, says CEO.

Public-private engage on climate change, same needs to happen for AMR, says DSM

12-Nov-2018 By Ben Hargreaves

Antimicrobial resistance is a global public health threat that both public and private organisations are struggling to combat.

Pfizer lowers guidance due to Hospira manufacturing issues

01-Nov-2018 By Ben Hargreaves

Pfizer has updated its 2018 financial guidance due to ‘lower-than-anticipated’ Essential Health revenue.

CPhI Worldwide

Brexit only a UK concern? Think again, says NSF director

19-Oct-2018 By Ben Hargreaves

As negotiations continue and discussions on ‘hard Brexit’ outcomes build, few have considered the impact on European industry, one organisation suggests.

China delivers $1.3bn fine to vaccine producer over data falsification

17-Oct-2018 By Ben Hargreaves

Chinese authorities deliver fine totalling more than $1.3bn Changchun Changsheng for the illegal production of vaccines.

EMA places Zhejiang Huahai under ‘increased supervision’ over quality issues

17-Oct-2018 By Ben Hargreaves

The EMA has placed Zhejiang Huahai under supervision, after the firm produced valsartan medication contaminated by probable carcinogens.

Getting serious about serialization

12-Oct-2018 By Ben Hargreaves

A surprising number of companies have underestimated the complexity of introducing serialization into their supply chains, claims rfxcel co-founder.

OTC test lab or microbrewery? US FDA warns lab for mixing beer tech with media

24-Sep-2018 By Flora Southey

The US FDA has issued a warning letter to contract testing laboratory Pharmaceutical Laboratories and Consultants, Inc., after a microbrewery was found to be operating in shared space.

EU-US mutual recognition extends with Portugal added to roster

24-Sep-2018 By Ben Hargreaves

With the US recognising Portugal’s ability to carry out GMP inspections, 15 countries are now part of the mutual recognition agreement between the EU and the US.

CMO for Pfizer ADHD drug hit with US FDA warning

10-Apr-2018 By Dan Stanton

The US FDA has sent a warning letter to Tris Pharma, a New Jersey-based manufacturer that makes ADHD drug Quillivant XR (methylphenidate HCl) for Pfizer.

ADENTS SERIALIZATION SUMMIT

Siemens: Inspectors quick to adapt to digital batch records

10-Apr-2018 By Flora Southey

Regulators are often more willing to support digital batch records than drugmakers, says Siemens.

UPDATE

Plant issues plague Celltrion and Teva as FDA issues two biosimilars CRLs

05-Apr-2018 By Dan Stanton

The US FDA has issued complete response letters (CRL) for the Rituxan and Herceptin biosimilar candidates after Celltrion’s facility received a warning in Janaury.

Ongoing regulatory issues helps downgrade Wockhardt’s ratings

03-Apr-2018 By Dan Stanton

India Ratings has downgraded Wockhardt partly on the back of ongoing remediation at seven manufacturing facilities.

Consortium looks to make bacteria for anti-inflammatory drug delivery to the gut

29-Mar-2018 By Dan Stanton

Porton Biopharma will look to develop GMP manufacturing capabilities for Clostridia bacteria as part of a UK collaboration developing aimed at developing microbiome targeted therapeutics.

Double US FDA audit for Granules India ends with one observation

26-Mar-2018 By Staff Reporter

Granules India has received a US FDA Form 483 with one observation at a Telangana API and finished formulation facility.

Alembic receives FDA 483, but no repeat observations nor data issues

22-Mar-2018 By Staff Reporter

Alembic Pharmaceuticals has received a US FDA Form 483 with three observations at a finished formulation plant in Gujarat, India.

IPEC and PDA team on excipient risk assessment guidance

22-Mar-2018 By Dan Stanton

IPEC Federation and PDA will publish a technical report in 2019 to provide drugmakers guidelines on how to implement risk assessment challenges of excipient supply.

Contamination risk from vermin lands Indian API firm with US warning

21-Mar-2018 By Dan Stanton

Inspectors observed birds and insects inside an API facility run by Malladi Drugs & Pharmaceuticals, according to a US FDA warning letter.

Dr Reddy's receives FDA 483 at Indian API plant

19-Mar-2018 By Dan Stanton

The US FDA has issued a Form 483 with four observations to an API facility in Hyderabad, India run by Dr Reddy’s Laboratories.

US FDA slams French lab for compromising supply chain accountability

15-Mar-2018 By Dan Stanton

Contract analysis firm Quali-Controle & Quali-Controle has received a US FDA warning after violating GMP in the testing of finished pharmaceuticals.

Two more OTC makers slammed with US FDA warnings

08-Mar-2018 By Dan Stanton

The US FDA warnings sent to Chinese and Hong Kong-based firms are the latest examples of OTC makers struggling to comply with pharmaceutical standard GMP.

Demand for HPAPIs and quality driving investments at Indena

07-Mar-2018 By Dan Stanton

Indena says industry’s recognition of the high quality of Italian-made ingredients has driven investments in an HPAPI kilolab and a multi-purpose pilot plant near Milan.

Latest GMP crackdown leaving ‘naive’ cosmetic firms with FDA warnings

06-Mar-2018 By Dan Stanton

Increased enforcement of cGMP on over-the-counter (OTC) drugs is highlighting the grey-area in classification with cosmetic products, a former FDA director says.

Aurobindo injectables plant receives Form 483 with nine observations

05-Mar-2018 By Dan Stanton

The US FDA has issued a Form 483 to a manufacturing plant in Hyderabad, India but Aurobindo says none of the observations relate to data integrity.

Pfizer’s McPherson site: Recalls and repeat observations

26-Feb-2018 By Flora Southey & Dan Stanton

The detection of cracks of the surface of glass vials has prompted a voluntary recall of Labetalol Hydrochloride Injection made at Pfizer’s troubled McPherson, Kansas facility.

Sun’s troubled Halol plant earns another FDA 483

26-Feb-2018 By Dan Stanton

The latest US FDA inspection at Sun pharma’s facility in Halol, India has ended with a Form 483 with three observations.

Biocon says FDA 483 at Malaysian plant not due to non-compliance

21-Feb-2018 By Dan Stanton

A US FDA pre-approval inspection of Biocon’s insulin manufacturing facility in Malaysia has resulted in a Form 483 with six observations.

USV receives FDA close-out at Indian plant

20-Feb-2018 By Staff Reporter

The US FDA has lifted a warning at an Indian oral solid dose manufacturing facility run by USV Private Limited.

ImmunoGen closing MA plant: 20 jobs to go, $20m in savings

15-Feb-2018 By Staff Reporter

ImmunoGen says it is shifting drug conjugate manufacturing and quality testing to an outsourcing model and will close its Norwood facility.

Remediation and modernisation plans: Bayer responds to FDA warning

14-Feb-2018 By Dan Stanton

Bayer expects some temporary supply limitations affecting its mature product portfolio as it addresses GMP issues raised in a US FDA warning.

US FDA slams Bayer for ‘inadequate cleaning' and 'discarded records’

13-Feb-2018 By Dan Stanton

Bayer has received a US FDA warning letter at its finished pharmaceutical facility in Leverkusen, Germany.

AstraZeneca aims for ZS Pharma kidney drug approvals in H1 2018

06-Feb-2018 By Dan Stanton

AstraZeneca says its hyperkalaemia candidate ZS-9 is back on track for approval after manufacturing issues at its Texas facility resulted in regulatory delays.

Danish regulators slam Indian API maker for GMP failings

05-Feb-2018 By Staff Reporter

Kadam Exports Private has received a statement of non-compliance with GMP after the Danish Medicines Agency found manufacturing deficiencies at its facility in Gujarat.

Teva's volatility and Pfizer's plant upgrade a threat to rating, S&P

05-Feb-2018 By Dan Stanton

Standard and Poor's says it is considering lowering Teva’s rating as Momenta Pharmaceuticals’s generic version of Copaxone closes in on launch.

Celltrion slammed with US FDA warning at biosimilar site

02-Feb-2018 By Dan Stanton

Celltrion says supply of Pfizer’s Inflectra is secure, despite receiving a US FDA warning letter at its biosimilar production plant in Korea.

FDA upgrades Kansas plant but Hospira’s legacy continues to haunt Pfizer

31-Jan-2018 By Dan Stanton

The US FDA has upgraded the status of Pfizer’s McPherson manufacturing, hit with a warning letter last year.

Japanese API maker accused of falsifying data by US FDA

31-Jan-2018 By Dan Stanton

The US FDA has slammed Daito Kasei Kogyo Co in a warning letter for data integrity issues.

Amneal expands NY site ahead of Impax merger

30-Jan-2018 By Flora Southey

Amneal Pharmaceuticals expects to bring production of some Impax Laboratories’ drugs in-house through a 100,000 sq. ft. expansion at its site in New York state.

‘Ostracized and criticized’ Indian CRO hits US FDA with $50m lawsuit

29-Jan-2018 By Dan Stanton

Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns.

US FDA to take risk-based approach to biomanufacturing inspections

26-Jan-2018 By Dan Stanton

A risk-based approach to inspection regulations could result in increased audits of more complex manufacturing sites, the US FDA says.

Quality surveyor? Rephine launches QA documentation database for APIs

24-Jan-2018 By Dan Stanton

Rephine says its online Quality Assurance database transforms the lengthy active pharmaceutical ingredient (API) pre-selection process to just a couple of clicks.