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US Wockhardt subsidiary Morton Grove warned by US FDA

06-Mar-2017 - The US FDA has warned Wockhardt Limited about operations at its US subsidiary Morton Grove Pharmaceuticals Inc. 

update

EU and US agree to share API and drug plant inspection data

02-Mar-2017 - The EU and US have agreed to recognize drug and API manufacturing plant inspections conducted in their respective territories under a deal signed this week.

US FDA clears Akorn's generic CellCept after Form 483 resolved

02-Mar-2017 - The US FDA has cleared Akorn Inc. to sell a generic version of the immunosuppressant CellCept made at its plant in Decatur, Illinois.

Cardboard and brown agglomerates: FDA slams Pfizer injectables plant

01-Mar-2017 - Particulate problems in sterile injectables and poor aseptic techniques landed Pfizer with a US FDA warning letter at a former Hospira facility in Kansas.

Dr. Reddy's' Miryalaguda plant issued with Form 483 after US FDA audit

23-Feb-2017 - Dr Reddy’s Laboratories has been issued with a Form 483 after an inspection at its active pharmaceutical ingredient (API) plant in Miryalaguda in Telangana, India.

Biolabex's Mauritius R&D lab open for business

23-Feb-2017 - Biolabex has opened a manufacturing and R&D laboratory at BioPark Mauritius, a biohub in Vacoas-Phoenix south of the capital Port Louis.

Momenta says Pfizer will fix plant but reiterates that Glatopa 40mg ANDA delay likely

22-Feb-2017 - Momenta Pharmaceuticals has reiterated its belief that problems at a US Pfizer plant mean the FDA is unlikely to reach a decision on its 40mg version of Teva’s Copaxone before April.

Takeda pulls Danish paracetamol batch after two packs found to contain ibuprofen

20-Feb-2017 - Takada Pharma A/S has recalled a batch of its Pamol paracetamol tablets in Denmark after two packs were found to contain ibuprofen.

Pfizer hit with US FDA warning at Kansas generic Copaxone site

20-Feb-2017 - The US FDA has issued a warning letter to the former Hospira fill and finish facility in McPherson, Kansas – now part of Pfizer’s contract manufacturing business CentreOne.

Tilray grows capacity in North America's only GMP cannabis facility

16-Feb-2017 - Medical cannabis supplier Tilray has expanded its formulary team and mooted the idea of extending its distribution network just weeks after the EMA granted its Canadian production site GMP accreditation.

Dr. Reddy's Laboratories continues European hospital market expansion

16-Feb-2017 - Dr. Reddy’s Laboratories Ltd has said it may invest in additional manufacturing capacity to support its efforts to grow in the European hospital drug market.

US FDA says Japanese OTC firm Sato must do more to fix plant problems

15-Feb-2017 - The US FDA says Sato Pharmaceutical Co., Ltd. has not addressed environmental monitoring shortcomings at its Tokyo plant.

Indian API maker slammed by US FDA for water and cleaning issues

14-Feb-2017 - The US FDA has issued a warning letter to Indian API maker Resonance Laboratories Private Limited citing inadequate cleaning procedures at its facility in Bangalore.

Symbiosis opens US sales office citing demand from resurgent biotechs

13-Feb-2017 - Symbiosis has opened an office in Boston, Massachusetts citing growing demand for vial filling services for highly potent APIs and large molecule injectable formulations.

Sanofi awaits FDA inspection of fill/finish plant before Q1 Kevzara resubmission

09-Feb-2017 - Sanofi intends to resubmit its licensing application for Kevzara within the next few weeks following subject to a US FDA re-inspection of a French fill/finish plant.

Pot luck? Medical marijuana's 'questionable quality’ no threat to pharma R&D

08-Feb-2017 - Pharma firms using cannabis-derived ingredients have hit out at the lack of standardization and the questionable quality of medical marijuana.

Banned wholesaler Europharma DK hires repackager Abacus Medicine and replaces CEO

06-Feb-2017 - Banned wholesaler Europharma DK has appointed a new CEO and hired Abacus Medicine to repackage and distribute drugs on its behalf.

FINANCIAL REPORT

Thermo Fisher's cautiously optimistic outlook for 2017

02-Feb-2017 - Thermo Fisher Scientific, Inc. saw revenue grow 8% in 2016, mostly due to acquisitions of new Chromotography and mass spectrometry tech and expanding its Bioproduction.

Chinese CDMO group buys New Jersey J-STAR for $26m

02-Feb-2017 - A US-subsidiary of the Chinese CDMO Porton Fine Chemicals Ltd. has bought the New Jersey based small molecule API contract research organisation, J-STAR Research, Inc. 

News in brief

AEMPS slams QC systems at Euro Far Alergi plant

01-Feb-2017 - Spanish regulators have criticised operations at a facility operated by vaccine firm Euro Far Alergi S.L.

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