QA/QC

Cadila says Moraiya drug plant has passed US FDA inspection

07-Sep-2017 By Gareth Macdonald

Cadila Healthcare says its formulation plant in Moraiya, Gujarat has passed a US Food and Drug Administration (FDA) inspection with no Form483 observations.

Celltrion confident in quality of biosimilar supply despite US FDA 483

07-Sep-2017 By Dan Stanton

Celltrion Inc has received a FDA Form 483 with 12 observations but remains confident no exported biosimilar products have any quality issues.

Shimadzu buys CDMO AlsaChim

07-Sep-2017 By Staff reporter

Shimadzu has acquired French radiolabelling contractor AlsaChim. 

Centurion Labs pulls products over Burkholderia cepacia concerns

04-Sep-2017 By Staff reporter

Centurion Labs has recalled two lots of cold and allergy meds after the US FDA warned they may have been made at a Pharmatech LLC plant linked to a Burkholderia cepacia outbreak.

US FDA adds Mahendra Chemicals to import alert "Red List"

30-Aug-2017 By Gareth Macdonald

Mahendra Chemicals has been banned from shipping drug ingredients made at its plant in Ahmedabad, India to the US.

Dissolution testing and dirty gaskets: US FDA warns Hetero Labs

30-Aug-2017 By Dan Stanton

The US FDA has sent a warning letter to Hetero Labs Limited citing GMP violations at its finished dose formulations facility in Telangana, India.

Manufacturers, wholesalers or 3PLs? US FDA guidance looks to define supply chain roles

24-Aug-2017 By Dan Stanton

The US FDA has released draft guidelines to identify trading partners in the pharma supply chain in accordance with the Drug Supply Chain Security Act (DSCSA).

FDA, EMA agree to share confidential info to further mutual recognition

23-Aug-2017 By Melissa Fassbender

The FDA and EMA have reached a new milestone during the process to implement mutual recognition of drug manufacturing facility inspections.

Rodent faeces and damaged equipment land Chinese OTC maker FDA warning

23-Aug-2017 By Dan Stanton

The US FDA has published a warning letter slamming the sanitary conditions of a Chinese OTC facility run by Bicooya Cosmetics Limited.

Germany refuses to renew GMP cert for Dr Reddy's Bachupally FTO 2 plant

10-Aug-2017 By Gareth Macdonald

German regulators have not renewed the GMP certificate for Dr Reddy’s manufacturing plant in Bachupally, Hyderabad.

US FDA warns against PharmaTech LLC-made meds over B.cepacia risk

10-Aug-2017 By Gareth Macdonald

The US FDA has warned doctors not to use any liquid drugs made by PharmaTech LLC over renewed concerns they may be contaminated with the bacteria Burkholderia cepacia.

Pfizer pulls lorazepam pills in Japan due to faulty engraving

10-Aug-2017 By Gareth Macdonald

Pfizer has recalled a batch of the antidepressant Wypax (lorazepam) in Japan after discovering faults with the engraving on some of the pills.

Class I drug recalls soared in Q2 according to new research

09-Aug-2017 By Staff reporter

More drugs were recalled in the US in the three months to the end of June than in any period since Q4 2014 according to analysis by Stericycle ExpertSolutions.

More fake Xeplion withdrawn in Denmark

01-Aug-2017 By Gareth Macdonald

A fourth batch of Janssen-Cilag’s schizophrenia drug Xeplion has been withdrawn in Denmark after the identification of counterfeit packs.

Torbay Pharma opens plant with sterile injectables capacity in UK

25-Jul-2017 By Gareth Macdonald

Torbay Pharmaceuticals has opened a £26m injectable drug manufacturing facility in Paignton, UK.

Chongquing Succeway made APIs in undeclared plant and faked records says ANSM

24-Jul-2017 By Gareth Macdonald

French regulators says Chongquing Succeway Pharmaceutical Co Ltd should recall APIs made at its plant in Chongquing after inspectors found evidence of record manipulation and an undeclared manufacturing area.

WHO prequalifies Mylan's India unit to supply TB drug API

20-Jul-2017 By Gareth Macdonald

The WHO has prequalified Indian-based Mylan Laboratories Ltd to supply the tuberculosis drug ingredient protionamide.

US FDA warns opthalmic supplier Tubilux about Italian plant

19-Jul-2017 By Gareth Macdonald

The US FDA has called on Tubilux Pharma SPA to identify potential contamination sources at its eye medicine production plant in Italy in a warning letter this week.

Unorderly Brexit will cause UK drug shortages warn industry groups

17-Jul-2017 By Gareth Macdonald

UK patients face drug shortages unless Tory Government Ministers negotiate an orderly withdrawal from the EU – Brexit – that safeguards existing approvals and continued regulatory cooperation according to pharmaceutical industry groups.

GE Healthcare and Oritain launch testing service to combat serum fraud

12-Jul-2017 By Gareth Macdonald

Cell therapy firms will be able to authenticate the foetal bovie serum (FBS) they use through a testing programme launched by GE Healthcare and Oritain.

US FDA warns Vista Pharmaceuticals about Telangana plant

11-Jul-2017 By Gareth Macdonald

Vista Pharmaceuticals Limited’s plant in Nalgonda, Telangana is in a state of disrepair according to the US Food and Drug Administration (FDA).

Mylan's EU biosimilar ambition hit by GMP issues at Biocon plant

10-Jul-2017 By Dan Stanton

Three biosimilar products submitted to the EU for approval have suffered a setback after regulators found 35 GMP deficiencies at Biocon’s fill/finish facility in Bangalore, India.

update

Pacira to stop making DepoCyt due to long-term production problems

06-Jul-2017 By Gareth Macdonald

Pacira Pharmaceuticals Inc. has said it will stop making the cancer DepoCyt (cytarabine), citing persistent manufacturing problems.

US FDA slams Chinese heparin API testing facility with warning

05-Jul-2017 By Dan Stanton

Failure to establish system suitability testing for heparin and heparin-related drugs has landed Shandong Analysis and Test Center a US FDA warning letter.

Brazil tells Bayer to recall 13 lots of Gynera contraceptive

28-Jun-2017 By Gareth Macdonald

Anvisa has ordered Bayer to recall 13 lots of the contraceptive Gynera (gestodene + ethinyl estradiol) over concerns about stability data.

Fagron and Advanced Pharma pull drugs made at Pfizer's Rocky Mount site

27-Jun-2017 By Gareth Macdonald

Fagron Sterile Services and Advanced Pharma have recalled lots of injectable drugs made at Pfizer’s Rocky Mount facility in North Carolina.

US FDA rejects Pfizer's Epogen biosimilar citing McPherson site warning

23-Jun-2017 By Gareth Macdonald

Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.

US FDA slams Chinese API maker over data breaches

22-Jun-2017 By Dan Stanton

Qinhuangdao Zizhu omitted, deleted and manipulated manufacturing data at its active pharmaceutical ingredient plant in Hebei, China according to the US FDA.

Corning life science focus: '21st century glass for 21st century drugs'

21-Jun-2017 By Dan Stanton

Corning says it is on the brink of capturing an increased share of the $12bn glass quality and packaging markets through material advancements in the space.

Pfizer recalls injectables made at Rocky Mount over potential contamination risk

19-Jun-2017 By Gareth Macdonald

Pfizer has recalled four injectables – including the already scarce heart surgery drug Sodium Bicarbonate - made at Hospira's facility in Rocky Mount, North Carolina after identifying a potential contamination risk.

Update with comment from MHRA

Europe tells API firms UK will be a “third country” like India and China after Brexit

15-Jun-2017 By Gareth Macdonald

The European Commission has confirmed that UK drug ingredient manufacturers will have to supply European customers with written confirmation their products are made in compliance with EU standards after Brexit.

update

AstraZeneca made Eliquis recalled in US says Bristol Myers-Squibb

15-Jun-2017 By Gareth Macdonald

Bristol Myers Squibb (B-MS) says the lot of Eliquis recalled in the US this week was made by AstraZeneca’s contract manufacturing business.

Update - BioMarin to hire 50 people at Shanbally

US FDA clears BioMarin to make $380,000-a year Vimizim in Ireland

12-Jun-2017 By Gareth Macdonald

The US FDA has cleared BioMarin Pharmaceutical Inc. to make the enzyme replacement drug Vimizim (elosulfase alfa) at its plant in Cork, Ireland.

B-MS recalls US Eliquis Lot after low dose pills found in 5mg bottle

12-Jun-2017 By Gareth Macdonald

Bristol Myers Squibb (B-MS) has recalled one lot of the oral anti-clotting drug Eliquis in the US after a customer found 2.5mg strength tablets in a bottle labelled as containing 5mg tablets.

Q&A with the 'Medical Futurist'

'If only everyone's supply chain was as regulated and secure as pharma’s'

05-Jun-2017 By Dan Stanton

3D printing, augmented reality and deep learning algorithms will shape the future of the pharmaceutical supply chain says Dr Bertalan Mesko, the Medical Futurist.

Visible particulates and leaking bags land B Braun Cali plant with FDA warning

31-May-2017 By Dan Stanton

The US FDA has slammed B. Braun Medical for repeatedly failing to thoroughly investigate quality concerns at a drugmaking facility in California.

Drug industry disaster concerns prompted lab expansion says Intertek

30-May-2017 By Gareth Macdonald

Drug industry concerns about natural disasters are driving demand for ‘storage-only’ stability testing according to Intertek, which has announced plans to expand its UK lab.

US ban for Changzhou Jintan Qianyao raises questions about customers says expert

24-May-2017 By Gareth Macdonald

The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”

US FDA warns liquid drug firms to test for Burkholderia cepacia

23-May-2017 By Gareth Macdonald

Burkholderia cepacia contamination is a risk for drug makers according to the US FDA, which says only rigorous testing can ensure the safety of non-sterile, water-based products.

France's ANSM raises GMP concerns at Brazilian aseptic plant

17-May-2017 By Dan Stanton

Nova DFL’s dental adrenaline product has been denied marketing authorisation after French regulators raised seven critical deficiencies at its facility in Brazil.

AB Science suspends French masitinib trials after ANSM finds deviations

15-May-2017 By Gareth Macdonald

AB Science SA has halted French trials of its Ph III drug candidate masitinib after regulators uncovered good clinical practice (GCP) and pharmacovigilance deviations in an earlier study.

Trump needs to back bioscience to boost US drug making say experts

11-May-2017 By Gareth Macdonald

President Donald Trump should foster biotech investment if he wants more US-made pharmaceuticals say experts who argue that cutting regulations to attract small molecule drug manufacturers will only have a limited effect.

Italian regulators find problems at Kores' API plant in Roha

10-May-2017 By Gareth Macdonald

Italian regulators say Kores Limited’s facility in Roha, India should be banned from supplying the API ambroxol hydrochloride to the EU and advised users to find an alternative source.

US FDA sends Biocon Bangalore plant 483 with 8 observations

10-May-2017 By Dan Stanton

Issues in the quality testing of drug substance and product were among eight observations cited in a Form 483 following an inspection at Biocon’s site last month.

Vikshara says plant banned by US FDA has stopped making APIs

10-May-2017 By Gareth Macdonald

The US FDA has accused Vikshara Trading & Investments Ltd. of giving false statements about a strike to delay the inspection of an Ahmedabad API plant later found to be non-compliant.

US FDA warns Indian API maker for faking certificates of analysis

03-May-2017 By Dan Stanton

Falsified certificates of analysis (COA) and misbranding violations have landed Indian API maker Sal Pharma a US FDA warning letter.

BPI Europe 2017

Roche on excipient inconsistencies: ‘Don’t blame suppliers, work with them’

02-May-2017 By Dan Stanton

An inconsistent lot of excipient Poloxamer 188 cut biologic yield 30%, but working with supplier BASF was key to prevent future problems, according to Roche.

Dr Reddy's: No production halt at Bachupally plant hit with Form 483

02-May-2017 By Gareth Macdonald

The US FDA has identified problems at Dr Reddy’s generic drug manufacturing site in Bachupally, India according to a filing on the Bombay Stock Exchange (BSE).

Management’s management of quality still a problem say MHRA inspectors

26-Apr-2017 By Gareth Macdonald

The UK MHRA saw an increase in sterility issues at drug plants in 2016 although quality system problems remained the most common deficiency seen during inspections.

update

US FDA warns Lonza about Walkersville site

25-Apr-2017 By Gareth Macdonald

The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.