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UK MHRA announces pre-election quiet period

21-Apr-2017 - Tory Prime Minister Teresa May’s decision to call a snap general election to stymie political opposition of her stewardship of the UK’s withdrawal from the European Union will see the MHRA limit communication to essential information.

Wearable drug delivery tech firm Unilife files for Chapter 11 bankruptcy

20-Apr-2017 - Unilife Corporation has filed for Chapter 11 bankruptcy and confirmed that a key customer for its wearable injectors business has halted a project.

EMA and FDA agree how drug firms should include Q8, Q9 and Q10 QbD concepts in applications

20-Apr-2017 - The EMA and US FDA say they agree on how pharmaceutical firms should include quality-by-design (QbD) elements in drug approval and manufacturing change applications, citing a recently completed pilot collaboration.

Aurobindo Pharma gets Form 483 from US FDA after Bachupally inspection

19-Apr-2017 - The US FDA completed an inspection of Aurobindo Pharma Limited’s manufacturing plant in Bachupally, Hyderabad yesterday, issuing the Indian drug firm with a Form 483 detailing six observations.

1st Stem Cell Community day in Germany

For stem cells 'the process is the product,' says Pluristem

19-Apr-2017 - Manufacturing tweaks have severe effects on the quality and yield of stem cells, says Pluristem which has successfully scaled-up production through a decade of process development evolution.

US ban for levonorgestrel supplier Qinhuangdao Zizhu raises WHO concerns

19-Apr-2017 - Discovery of data problems at Qinhuangdao Zizhu’s Hebei API plant indicates the firm did not follow a remediation plan agreed after a prequalification inspection in 2015 according to the WHO.

update

Teva confirms US FDA warning letter for Hangzhou, China API plant

18-Apr-2017 - Teva Pharmaceutical Industries says the US FDA has raised concerns about its API plant in Hangzhou, China.

UK firms should look to global opportunities to offset Brexit woes, says biotech CEO

18-Apr-2017 - UK life science companies must become global to help offset staffing and funding problems potentially caused by Brexit, says Arecor CEO Sarah Howell.

Japanese drug production grew in 2015 according to new MHLW data

12-Apr-2017 - Domestic pharmaceutical production increased in Japan in 2015 according to data released by the MHLW.

US FDA criticizes quality systems at Mylan NV's Nashik plant

12-Apr-2017 - The US FDA has criticized quality systems at Mylan’s HIV drug plant in Nashik in Maharashtra, India. 

EMA sets up inbox for pharma whistle-blowers and adopts investigation policy

11-Apr-2017 - The EMA has set up an email inbox for drug company employees who report improper manufacturing and trial activities.

US FDA hands Neuland Laboratories Form 483 after plant inspection

10-Apr-2017 - The US FDA has found fault at Neuland Laboratories Limited manufacturing facility in Bonthapally, India.

News in brief

US FDA OKs Cadila Healthcare topicals plant

10-Apr-2017 - Cadila Healthcare Limited says its topical drug manufacturing plant has passed an inspection by the US Food and Drug Administration (FDA).

Industry asks US FDA to "pause" data quality reporting plan

10-Apr-2017 - API, excipient and drug industry groups have reiterated concerns about the latest iteration of the US FDA’s “quality metrics” reporting requirements.

India cracks down on oxytocin makers to curb misuse in labour wards

06-Apr-2017 - India has told state regulators to inspect API sites making oxytocin in an effort to prevent the hormone being used to speed up childbirth without medical justification.

Medichem's solid dosage form plant approved by US FDA

06-Apr-2017 - A Combino Pharm dosage form plant in Malta has passed a US FDA inspection according to parent Medichem, which says it is now poised to expand its US business.

US FDA accepts Evoke's CMC and PK trial plan for nasal metoclopramide

05-Apr-2017 - The US FDA has accepted a manufacturing and trial plan for Evoke Pharma's Gimoti, the nasal metoclopramide formulation that fell short in a Phase III trial last year.

US FDA hits Indoco with warning due to leaky glaucoma drug

05-Apr-2017 - Leakage problems for of an ophthalmic drug has landed contract manufacturer Indoco Remedies with a US FDA warning letter at its plant in Goa.

Alkem says US FDA has accepted plan to fix Ankaleshwar API plant

04-Apr-2017 - Alkem Laboratories Ltd says the US FDA has accepted its plan to bring its API plant in Ankaleshwar, India up to code.

Dr Reddy's says US FDA has issued Form 483 for Srikakulam API plant

04-Apr-2017 - The US FDA has completed its inspection of Dr Reddy’s API plant in Srikakulam, Andhra Pradesh and issued the firm with a Form 483 detailing two observations.

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