
A recent meeting emphasized the need for more guidance and flexibility from regulators, as well as harmonization, standards and equipment interoperability.

A recent meeting emphasized the need for more guidance and flexibility from regulators, as well as harmonization, standards and equipment interoperability.

A consent decree of permanent injunction was entered between the United States and the two companies due to unapproved, mislabeled, and adulterated drugs.

The company has extended its voluntarily recall of one lot of paliperidone extended-release tablets to the consumer level due to dissolution test failure.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

The agency sent a warning letter to A-S Medication Solutions LLC after it found the company didn’t comply with drug listing file requirements.

The companies are partnering to provide new fill/finish facilities and solutions for biopharmaceutical products.

The company added a 40,000-ft2 purpose-built R&D center at 17112 Armstrong Ave, Irvine, CA.

FDA Commissioner Scott Gottlieb announced the July meeting as part of his commitment to address opioid abuse.

FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.

Aptar now manufactures its child-resistant pump, designed to meet US CPC requirements, at its facility in Congers, New York.

At an industry seminar hosted by Leistritz Extrusion, experts explained the use of extrusion equipment to mix polymeric excipients with APIs for solubility enhancement and for multifunctional and specialty dosage forms, including implants.

The companies are collaborating to interface the Waters Acquity QDa Mass Detector with the IonSense DART ionization source.

The company is voluntarily recalling one lot of Eliquis after a patient discovered that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets.

The company said it expects to transaction to close on June 16, 2017.

The three regulatory agencies have agreed to data requirements for development of new antibiotics.

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.

In its June meeting, the agency’s Pharmacovigilance Risk Assessment Committee discussed medicine safety reviews.

Proceeds from the sale will be used to repay the company’s term loan debt under its Senior Secured Credit Facility.

Germany-based Grünenthal will gain rights to market and sell Zomig (zolmitriptan) outside of Japan.

The companies will collaborate on the development of dual amylin calcitonin receptor agonists for patients with Type 2 diabetes.

The company released an interim analysis from its JULIET study with CTL019.

FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.

The new training center will feature technologies that boost biomanufacturing.

The United Kingdom’s Center for Process Innovation (CPI) is investing in a new project, Microstar, which seeks to reduce risk for formulators through the development of accelerated screening methods for predictive design.

Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.

Lubrizol Invests $60 Million to Expand Particle Sciences and Other Facilities in 2017.

Takeda will build a new production facility at its existing Grange Castle site in Ireland.

Acasti Pharma and CDMO CordenPharma designed and implemented a continuous process for purifying raw krill oil for production of omega-3 phospholipid.

The company will be acquired for $21.75 per share in cash.

The company announced that it is fully compliant with the 2017–2023 serialization and aggregation requirements.