06-Mar-2017 - The US FDA has warned Wockhardt Limited about operations at its US subsidiary Morton Grove Pharmaceuticals Inc.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
15-Feb-2017 - The US FDA says Sato Pharmaceutical Co., Ltd. has not addressed environmental monitoring shortcomings at its Tokyo plant.
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.
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.
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.
08-Feb-2017 - Pharma firms using cannabis-derived ingredients have hit out at the lack of standardization and the questionable quality of medical marijuana.
06-Feb-2017 - Banned wholesaler Europharma DK has appointed a new CEO and hired Abacus Medicine to repackage and distribute drugs on its behalf.
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.
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.
01-Feb-2017 - Spanish regulators have criticised operations at a facility operated by vaccine firm Euro Far Alergi S.L.
Monitoring spatial product temperature variation is critical to process development and scale-up in the pharma/bio-pharmaceutical indu...