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Serialisation, automation and data integration: Zenith talks manufacturing in 2017

19-Jan-2017 - The implementation of serialisation regulations in 2017 are among the opportunities for drugmakers to improve manufacturing efficiencies, says IT and engineering firm Zenith Technologies.

SUKL finds GDP problems at B.Braun warehouse in Czech Republic

19-Jan-2017 - Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of good distribution practice (GDP) guidelines.

GAO wants US FDA to show benefits of overseas inspections

18-Jan-2017 - The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.

US FDA slams Suzhou Pharmaceutical Technology for copy and paste CoAs

18-Jan-2017 - Suzhou Pharmaceutical Technology faked quality documents, shipped a banned supplier's API to the US and failed to store materials properly according to the US FDA. 

Janssen-Cilag switches Haldol supplies to Switzerland after production problems

17-Jan-2017 - Problems at a CMO have forced Janssen-Cilag to ship Haldol made in Austria to patients in Switzerland to maintain supplies.

Biosimilar interchangeability

FDA calls for switching studies in draft interchangeability guidelines

17-Jan-2017 - The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.

India clamps down on OTC antibiotic sales to stem spread of superbugs

16-Jan-2017 - The CDSCO has urged pharmacies to stop selling prescription antibiotics over-the-counter in an effort to slow the spread of antimicrobial resistance.

EFPIA and ABPI urge UK to keep drug regs consistent with EU post Brexit

16-Jan-2017 - Industry groups have reiterated calls for UK drug approval and safety laws to be kept in line with EU rules, arguing that consistency benefits governments and patients Europe-wide.

update

Trump vows to bring drug production back to US

12-Jan-2017 - President elect Donald Trump has said he will bring drug manufacturing back to the US and introduce bidding measures to cut the amount the country spends on medicines. 

US FDA finalises combination drug/device product guidance

12-Jan-2017 - The US FDA has finalised its guidelines on cGMP and quality system compliance for drug and delivery device combination products.

Aerie to build manufacturing facility in Ireland

11-Jan-2017 - Aerie Pharmaceuticals Inc will lease a 30,000 sq ft manufacturing facility in Ireland to commercialise its eye-drop product for Glaucoma after delays at a third party CMO.

Day 2

JP Morgan Conference: Trumpcare, moonshots and M&A

10-Jan-2017 - If you're not going to San Francisco, in-Pharmatechnologist brings you a smattering of the best tweets from the 35th Annual JP Morgan Healthcare Conference.

Danish regulators ban Europharma DK ApS and suggest firm needs new CEO

09-Jan-2017 - Danish regulators have banned Europharma DK ApS from making or importing medicines and drug intermediates after identifying serious breaches of GMP at its plant in Esbjerg.

US DEA finalises controlled substance and equipment revisions

09-Jan-2017 - Drugmakers must include a transaction identification number when buying or selling machinery for tabletting or encapsulating controlled substances, according to a final ruling from the US DEA.

Out with the old, in with the new? Lonza sells peptide biz, Recipharm adds Indian ops

05-Jan-2017 - Recipharm receives approval to buy Kemwell’s Indian operations and PolyPeptides completes the acquisition of Lonza’s peptide business. Welcome to in-Pharmatechnologist’s 2017 M&A round-up.

Data integrity and aseptic issues land Wockhardt with FDA warning

04-Jan-2017 - A Wockhardt facility in India put under import alert last year has received a US FDA warning letter citing issues ranging from data discrepancies to inappropriate aseptic clothing.

Fire at Sun Pharma API factory kills two

04-Jan-2017 - Late last week, a fire at Sun Pharmaceutical Industries Limited’s Ahmednagar factory, which manufactures APIs, sent four employees to the hospital.

Data integrity concerns: EMA reviews drugs tested by Micro Therapeutic Research

22-Dec-2016 - The EMA has started reviewing drugs tested by Micro Therapeutic Research Labs after an inspection by Dutch and Austrian regulators identified potential data integrity problems.

Laboratorio Angulema warned by Spanish regulators about Leganes plant

20-Dec-2016 - Spanish regulators have found problems at a facility operated by immunotherapy producer Laboratorio Angulema.

US FDA has concerns about Granules - Ajinomoto OmniChem's Vizag API plant

20-Dec-2016 - US FDA inspectors have raised questions about an API manufacturing facility in India that is operated by Granules India and Ajinomoto OmniChem.

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