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Internal FDA Guidance Further Constrains GDUFA III Get-Out-Of-OAI Card

 
• By Bowman Cox

Generic drug firms won a narrow commitment from the US FDA to approve ANDAs without revisiting sites previously deemed deficient. But the agency's just-issued MAPP document implementing the commitment, which stems from pandemic-era travel frustrations, is narrower still. Recent reinspection results might explain why.

Monopoly get out of jail free card
more fine print on releasing andas from oai inspection results • Source: Shutterstock

The US Food and Drug Administration has established a set of policies and procedures it promised industry for approving generic drugs without manufacturing facility inspections despite quality concerns in certain constrained circumstances.

An internal guidance document the FDA posted 12 June fulfills a commitment the agency made as part of the third five-year reauthorization of user fees for generic drug reviews.

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More from Manufacturing

Hikma Eyes $5bn Sales Target As It Sets Out Plans To 2030

 
• By Dave Wallace

Unveiling a new name for its generics business, Hikma has at the same time set out medium-term financial goals for its business that include three-year growth objectives for its sales and profits, as well as aiming at a $5bn turnover target by 2030.

Viatris Awaits ‘Significant Rebound’ At Indore In 2026 After Painful Q1 Bite

 
• By Dean Rudge

Viatris continues to make progress on remediation at the firm’s stricken manufacturing facility in Indore, India, following a warning letter and import alert delivered at the tail end of 2024.

Dr Reddy’s Gears For Tariffs Scenario To Ensure No US Supply Disruption

 
• By Anju Ghangurde

Dr. Reddy's Laboratories preps for potential US tariffs, focusing on sustaining product supply and collaborating with customers on inventories. A recent US plant sale, the firm stressed, was unrelated to tariffs and underlines its openness to ‘make in the US’, where it launched 18 products in fiscal 2025.

Amneal Proud To Be ‘Made In America’ And Ready To Scale Up Its US Manufacturing

 
• By Urtė Fultinavičiūtė

Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.

More from Business

Krka Looks To Kick On In India And China

 
• By Dean Rudge

Krka has provided updates for its pair of joint ventures in two key Asian markets, India and China, as the Slovenian firm reported its first-quarter financial results.

Teva Brings In European Trastuzumab With Prestige BioPharma Agreement

 
• By Dean Rudge

Teva will now market biosimilar Herceptin in both the US and Europe, after penning an agreement with Singaporean firm Prestige BioPharma for its Tuznue rival to the monoclonal antibody to treat HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

SteinCares Deal Leads Lupin’s Ranibizumab Into Latin America

 
• By Dave Wallace

Lupin is planning to make inroads into the Latin American biosimilars market through a deal with local player SteinCares for a ranibizumab rival to Lucentis.