QA/QC

DSM Sinochem to up capacity at Delft antibiotic intermediates plant

24-Apr-2017 By Gareth Macdonald

DSM Sinochem (DSP) has announced its intention to increase antibiotic production capacity at its facility in Delft, the Netherlands.

Samsung Bioepis to take on J&J with FDA approved Remicade biosimilar

24-Apr-2017 By Dan Stanton

Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.

US ban for levonorgestrel supplier Qinhuangdao Zizhu raises WHO concerns

19-Apr-2017 By Gareth Macdonald

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.

1st Stem Cell Community day in Germany

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

19-Apr-2017 By Dan Stanton

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.

update

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

18-Apr-2017 By Gareth Macdonald

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

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

12-Apr-2017 By Gareth Macdonald

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

US FDA hands Neuland Laboratories Form 483 after plant inspection

10-Apr-2017 By Gareth Macdonald

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

US FDA OKs Cadila Healthcare topicals plant

10-Apr-2017 By Staff reporter

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Dan Stanton

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Staff Reporter

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 By Gareth Macdonald

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 By Dan Stanton

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 By Dan Stanton

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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.

German Merck taps up cell-based pyrogen detection kit

21-Mar-2017 By Staff Reporter

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

update

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

21-Mar-2017 By Gareth Macdonald

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.

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

16-Mar-2017 By Gareth Macdonald

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 By Dan Stanton

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

update - US FDA confirms lifting of import alert

Sun says US FDA poised to lift Mohali import alert

14-Mar-2017 By Gareth Macdonald

Sun Pharmaceutical Industries Ltd has said the US FDA plans to lift the import alert imposed on its manufacturing plant in Mohali, Punjab in India.

Denmark clears Europharma to sell drugs after reinspection

13-Mar-2017 By Gareth Macdonald

The Danish Medicines Agency (DKMA) has cleared Europharma DK ApS to resume drug sales and distribution after the firm appointed a new managing director.

Alkem Labs hit with FDA 483 with three observations at Indian plant

13-Mar-2017 By Dan Stanton

The US FDA has issued a Form 483 with three observations to Alkem Laboratories after an inspection at its facility in Himachal Pradesh, India.

Re-inspection lands Dr Reddy’s Form 483 with 13 observations at Duvvada plant

09-Mar-2017 By Dan Stanton

Dr Reddy’s Laboratories says it is addressing the observations at its Duvvada plant which was hit with a warning letter in 2015.

US FDA slams second Megafine facility in India with warning letter

08-Mar-2017 By Dan Stanton

A second Megafine Pharma plant has landed a US FDA warning letter for cGMP violations, including sourcing API intermediate materials from a facility on import alert.

update

Ireland's HPRA did not recommend GMP cert renewal for Wockhardt Shendra plant

08-Mar-2017 By Gareth Macdonald

The Health Products Regulatory Authority of Ireland (HPRA) has said it did not recommend renewal of the GMP certificate for Wockhardt’s site in Shendra, Aurangabad.

US FDA says Wockhardt's oversight of drug production inadequate

07-Mar-2017 By Gareth Macdonald

The US FDA has told Wockhardt its quality issues are company-wide, citing problems at subsidiary Morton Grove as an example in a warning letter published today.

update

Wockhardt says Ireland's HPRA has recommended GMP cert renewal for Shendra site

07-Mar-2017 By Gareth Macdonald

Wockhardt says Irish regulators have recommended renewal of its Shendra, Aurangabad facility's GMP certificate.

Keryx: Patheon and Norwich sites will ensure supply of iron-based Auryxia

06-Mar-2017 By Dan Stanton

Keryx Biopharmaceuticals will continue to work with Norwich Pharmaceuticals despite bringing Patheon on board to manufacture Auryxia (ferric citrate).