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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.

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.

Mylan pulls Epipens in US on worries about Pfizer-made anaphylaxis jab

03-Apr-2017 - Mylan has recalled batches of its EpiPen in the US over concerns the auto-injector device made by Pfizer’s Meridian Medical Technologies unit is faulty.

update - US FDA declines to comment on potential investigation

EMA says CRO monitoring activity not location based

30-Mar-2017 - The EMA has stressed its monitoring of CROs is location independent after raising concerns about third Indian contractor in two years.

US FDA wants evidence Opto-Pharm's Tuas plant remediation effort has worked

30-Mar-2017 - The US FDA has criticised Opto-Pharm Pte for selling unlicensed "drugs" and not bringing its Singapore manufacturing plant up to code.

Wockhardt says US FDA has approved Fresenius Kabi-made generic Zosyn

28-Mar-2017 - Wockhardt claims the US has approved its version of the combination antibiotic Zosyn (piperacillin and tazobactam).

EMA looks to suspend 331 drugs due to ‘misrepresentation of study data’ at Indian CRO

27-Mar-2017 - Sandoz and Aurobindo are among drugmakers which will need to provide alternative bioequivalence data after the EMA recommended suspension of medicines tested by Micro Therapeutic Research Labs.

Lilly: Tax reforms would release $150m to further support US manufacturing

27-Mar-2017 - Eli Lilly will invest $850m in its US operations this year but warns the country’s antiquated tax system leaves the firm at a competitive disadvantage.

Chiron AS cleared to make carfentanyl for opioid researchers

23-Mar-2017 - Reference material manufacturer Chiron AS has been cleared to make carfentanyl for opioid researchers working in Europe.

Divi's Labs' Vizag plant banned from shipping to US

23-Mar-2017 - Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the US.

update with comment from FDA

US FDA criticizes Indian drug firm USV for problems at multiple sites

22-Mar-2017 - The US FDA has called on Indian drug firm USV Private Limited to rethink how its tests for microbial contamination at its manufacturing facilities.

US FDA says Jinan Jinda Pharma must do more make Shandong plant compliant

22-Mar-2017 - Jinan Jinda Pharmaceutical Chemistry Co. Ltd has more to do to bring its drug ingredient plant in Shandong, China up to code according to the US FDA.


AstraZeneca gets second CRL for Zs-9 after inspection at Zs Pharma Texas plant

21-Mar-2017 - The US FDA has issued AstraZeneca with a second CRL for its hyperkalaemia candidate Zs-9 after finding problems at a Texas facility operated by subsidiary Zs Pharma.

News in brief

German Merck taps up cell-based pyrogen detection kit

21-Mar-2017 - Solvias has struck a deal with Germany’s Merck to supply a monocyte activation test (MAT) kit for detecting pyrogens in pharmaceutical raw ingredients.

US FDA says Badrivishal can't ensure safety of river water used at API plant

16-Mar-2017 - The US FDA has criticised Badrivishal Chemicals & Pharmaceuticals for failing to document production and monitor the efficacy of water purification systems at its API plant in Maharashtra.  

Misbranded epilepsy drug API lands FDA warning for Chinese ingredient maker

15-Mar-2017 - The US FDA has slammed China’s Lumis Global Pharmaceuticals for problems documenting and labelling active pharmaceutical ingredients.

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