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Pfizer Inc

HIGH RISKHQ: New York · NYSE: PFE · Founded 1849

LISTINGNYSE: PFEFOUNDED1849

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InnovatorVaccines

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NO ACTIVE REGULATORY ACTIONSClean compliance footprint across 9 monitored sites · HQ New York

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INTELLIGENCE

Showing 6 of 6 briefs on Aurobindo Pharma

REGULATORY INTELLIGENCE·USFDA

FDA import alert IA-66-47 extended to Aurobindo Unit VII API block after data-integrity findings

The agency widened the alert to cover additional peptide and antiretroviral intermediates, detaining shipments without physical examination pending remediation.

90-Day Activity

Aurobindo PharmaUnit VII · HyderabadUSFDAIA-66-47

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

18 min ago Import alert active

REGULATORY INTELLIGENCE·USFDA

Warning letter to Aurobindo cites OAI classification from March 2025 inspection of formulation unit

Investigators documented inadequate investigation of out-of-specification results and deficient cleaning validation across two shared injectable lines.

90-Day Activity

Aurobindo PharmaUnit IX · HyderabadUSFDAInjectables

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

5h ago OAI · Warning Letter

TRADE & SUPPLY CHAIN·EXPORT ALERT

Aurobindo antiretroviral API shipments to Africa climb 19% under global PEPFAR tenders

Dolutegravir and tenofovir volumes lead the gain as the company consolidates its position as the largest WHO-prequalified ARV supplier by tonnage.

90-Day Activity

Aurobindo PharmaDolutegravirWHO PQHSN 29349900

AMArjun Menon· Trade & Supply Chain Analyst

9h ago▲ 19% vs Q1 2026

MARKET INTELLIGENCE·EARNINGS

Aurobindo Q4 US revenue softens 6% as injectable remediation costs weigh on EBITDA margin

Management guided to elevated compliance capex through FY27 while Eugia injectables and the European retail arm offset US generic price erosion.

90-Day Activity

Aurobindo PharmaEugia PharmaInjectablesNSE

SASohail Ahmed· Market Intelligence Analyst

1d ago▼ 6% US revenue

CLINICAL & PIPELINE·BIOSIMILAR

CuraTeQ Biologics, an Aurobindo unit, files trastuzumab biosimilar with EMA for oncology launch

The submission advances Aurobindo's biologics pivot, adding a high-value oncology asset to a pipeline still dominated by small-molecule generics.

90-Day Activity

CuraTeQ BiologicsTrastuzumabEMAAurobindo Pharma

PBPriya Bansal· Clinical & Pipeline Intelligence Analyst

2d ago▲ Biosimilar filed

REGULATORY INTELLIGENCE·EU GMP

EU GMP certificate renewed for Aurobindo Pydibhimavaram API mega-site after EDQM inspection

A clean outcome at the company's largest API campus provides a compliant second source as US-facing units work through remediation.

90-Day Activity

Aurobindo PharmaPydibhimavaram · APEDQMAPI

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

3d ago▲ GMP renewed