API Synthesis and Manufacturing

Seeking Solutions for Oral Delivery of Biologic APIs

Researchers continue efforts to overcome challenges of effective oral delivery of biologic drugs.
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FDA Warns API Manufacturer about Quality and Data Integrity Issues

The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.
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China API Facility Receives FDA Warning Letter

The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.
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RSSL Expands Particle Characterization Capabilities

RSSL has added new equipment for measuring the surface area of powder particles, which is important for determining the performance of excipients and APIs.
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JRS Pharma Adds Povidone Product Line

Excipient manufacturer adds three tablet binding and disintegration products.
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Outsourcing Update

Should More Pharma Products be Made in the USA?

What are the pros, cons, and practicalities of moving pharma manufacturing back to the US?
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In the Lab

Technology to the Rescue for Data Integrity Challenges?

Informatics platforms and automation solutions may support efforts to improve data integrity practices.
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Supply Chain Update

Putting GS1’s EPCIS Standards to the Test

In a pilot program, Johnson & Johnson Supply Chain and AmerisourceBergen demonstrated how data can be transferred between two partners.
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Contract Services Update

Capsugel Installs New Encapsulation Unit for DPI Applications at Bend, Oregon Facility

The newly installed Harro Höfliger encapsulation unit expands Capsugel's clinical- and commercial-scale capacity for dry powder inhalation projects.
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Permira Funds to Acquire LSNE

Permira will acquire LSNE, a CDMO for the pharmaceutical and medical device markets.
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Butterworth Laboratories Expands UK Lab Operations

The company has secured an additional facility in Hampton, Middlesex, as part of a project to expand its UK-based operations by 15% in 2017.
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Eurofins Scientific Invests in New UK Facility

The company has invested in a new pharmaceutical chemistry and microbiology facility in Scotland.
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Hitachi Chemical Purchases PCT From Caladrius Biosciences

Caladrius is selling the remaining percentage of the subsidiary to focus on cell therapy development.
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CMO Pfizer CentreOne Adds Highly Potent Solid Oral Dose to Portfolio

Manufacturing will be carried out at the Pfizer Newbridge, Ireland, facility, which is now part of Pfizer CentreOne's contract manufacturing network.
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