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The Quality Lowdown: CMC Challenges Include Pfizer Unit's Quest For Injectable Acetaminophen

 
• By Bowman Cox

Pfizer’s InnoPharma unit finally overcame US FDA’s concerns about injectable acetaminophen GMPs and leachables. Meanwhile, Azurity resolved zonisamide manufacturing issues, Amphastar overcame doubts about naloxone’s nasal spray device, Incyte reused Zynyz CMC data, Cidara showed Rezzayo vials had enough powder, Pharming showed equivalence between Joenja tablets and capsules, and Orphalan avoided half-tablet stability testing of its functionally scored Cuvrior tablets.

The Quality Lowdown
a lowdown on cmc reviews

This edition of the Pink Sheet’s Quality Lowdown takes a look at some of the bumps in the road and decisions made along the way in recent chemistry, manufacturing and controls reviews as assessors in the US Food and Drug Administration’s Office of Pharmaceutical Quality determine whether they believe sponsors will be able to properly manufacture the new drugs they seek to market in the US.

Here, then, are some of the latest CMC lessons as described in redacted drug approval packages the US Food and...

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More from Manufacturing

US FDA ANDA Priority Pilot ‘Practically Unusable’ Without Tweaks, AAM CEO Says

 
• By Sarah Karlin-Smith

Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.

New GMP Reliance Approach In Argentina Could Save Time For Companies

 
• By Francesca Bruce

New rules in Argentina mean that good manufacturing practices certificates for foreign drug manufacturing plants issued by certain regulatory authorities could lead to quicker GMP certification evaluations.

Pink Sheet Podcast: US FDA Cuts Biosimilar Requirements, Clarifies Inspection Reform

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss FDA announcements that clinical efficacy studies would no longer be required for biosimilar development, as well as the additional information from the agency on the intent of its “Simple Reform” of the inspection staff.

‘Simple Reform’ Not A Step Back From Program Alignment, US FDA’s Elizabeth Miller Argues

 
• By Derrick Gingery

Miller, FDA acting deputy associate commissioner for inspections and investigations, said veteran inspectors will retain their specialties and potentially acquire new expertise, while new recruits will begin as generalists and then be encouraged to pick a focus area.

More from Compliance

MLR Reviews: How To “Shift Left” With Agentic AI, Balance Compliance And Creativity

 
• By Vibha Ravi

Experts from UCB, Alnylam, Lantheus and Medtronic deliberate on the best use of agentic AI in the MLR review process, its human replaceability quotient and ways to balance creativity with compliance, a significant discussion amid DTC advertising and US FDA scrutiny

‘Simple Reform’ Not A Step Back From Program Alignment, US FDA’s Elizabeth Miller Argues

 
• By Derrick Gingery

Miller, FDA acting deputy associate commissioner for inspections and investigations, said veteran inspectors will retain their specialties and potentially acquire new expertise, while new recruits will begin as generalists and then be encouraged to pick a focus area.

US FDA Social Media Crackdown Looms As Industry Awaits Next Drug Ad Enforcement Wave

 
• By Sue Sutter

The first round of ad/promo violation letters largely left social media untouched despite a vow to go after “dark ads” and violative influencer claims. Industry wants more information on the new, de facto standards suggested in the initial DTC and healthcare provider promotion letters.