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Suitability Petition - Emprise Pharma on Behalf of Shandong New Time

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Summary

Emprise Pharma LLC filed a suitability petition with FDA on behalf of Shandong New Time Pharmaceutical Co., Ltd requesting agency determination on proposed changes to an approved drug product. The petition has been assigned docket number FDA-2026-P-3840-0001 and is under review by CDER.

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What changed

Emprise Pharma LLC submitted a suitability petition to FDA on behalf of Shandong New Time Pharmaceutical Co., Ltd seeking agency determination on whether proposed changes to an approved drug product are appropriate. The petition has been filed with CDER and assigned to docket FDA-2026-P-3840-0001 for processing.

Affected parties include pharmaceutical companies and manufacturers seeking FDA approval for modifications to approved drug products through the suitability petition pathway. The filing represents a routine regulatory request that does not immediately affect compliance obligations but will establish precedent for the requested product modifications upon FDA determination.

What to do next

  1. Monitor for FDA response to the suitability petition

Archived snapshot

Apr 10, 2026

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Content

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Attachments 1

Suitability Petition from Emprise Pharma LLC on behalf of Shandong New Time Pharmaceutical Co., Ltd

More Information
- Author(s) CDER
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Classification

Agency
FDA
Instrument
Notice
Legal weight
Non-binding
Stage
Draft
Change scope
Minor
Document ID
FDA-2026-P-3840-0001
Docket
FDA-2026-P-3840-0001

Who this affects

Applies to
Pharmaceutical companies Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug product modifications Regulatory petition filing
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Regulatory Affairs
Compliance frameworks
GxP
Topics
Healthcare Intellectual Property

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