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Regulation

Set Alert for Regulation

The Factory Floor: Suanfarma Expands API Capacity With Sandoz Deal In Italy

Suanfarma acquires an API manufacturing facility in Italy to accelerate its growth in Europe, while CapsCanada relocates its headquarters as part of its growth strategy. Meanwhile, Glenmark, Aurobindo and Cipla struggle with quality issues.

Manufacturing Regulation

AAM Slams California Pay-For-Delay Ban

US off-patent industry association the AAM has blasted as unconstitutional a groundbreaking California law banning so-called ‘pay-for-delay’ deals under which brand companies pay rivals to keep generics off the market.

Regulation Legislation

FDA Fights Problems With Pre-ANDA Meeting Requests

More meeting requests are being denied because the sponsor's pre-meeting package was incomplete, the agency said.

Regulation Generic Drugs

Nitrosamine Issue Presages Paradigm Shift In Quality

The detection of cancer-causing impurities in drugs with well-established safety profiles may force regulators across the globe to revise their approach for evaluating quality.

Manufacturing Regulation

First UK Serious Shortage Protocol Issued For Fluoxetine

The first Serious Shortage Protocol has been issued by the DHSC to tackle supply disruptions for fluoxetine capsules. The protocol came into effect on 3 October 2019 and will expire at the end of the month.

Regulation United Kingdom

US Biosimilar Fee Collections Fall Short

A lower-than-expected number of fee-paying application submissions in FY 2018 resulted in the agency spending approximately $9.7m more than anticipated from its user fee carryover balance, leading to a reset of spend-down targets for the remainder of BsUFA II.

Regulation Biosimilars
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