Entities / Entity
United States Food and Drug Administration.
agency of the US Department of Health and Human Services
- Reports this week
- 2
- Active events
- 2
- Connections
- 579
What's happening
Reports per dayLast 90 days
90 days agoDrag either end to show only events that began in that periodToday
Active this week
Earlier this month
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USFDA conducted an inspection at Granules facility on November 1, 2026.Some support1 report
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USFDA conducted a Pre-Approval Inspection of Gufic Biosciences Limited's manufacturing facility located in Pithampur.Some support1 report
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Dr. Reddy's Laboratories' manufacturing facility in Visakhapatnam underwent a USFDA pre-approval inspection.Some support1 report
One to three months ago
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FDA inspected manufacturing facilities in Satara and East Brunswick on October 9, 2026.Some support1 report
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FDA gave tentative approval to Lupin for an alternative formulation of a Bristol-Myers Squibb drug, which Lupin plans to manufacture in Somerset.Some support1 report
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FDA inspection at Unichem Laboratories Limited's Goa facility found procedural enhancements needed, leading to market reaction.Some support2 reports
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AbbVie and Cerevel Therapeutics successfully launched a new drug for Parkinson's disease, pending government coverage negotiations.Some support3 reports
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Routine cGMP inspection found three observations at a Strides Pharma Science Limited manufacturing facility in Chennai.Some support1 report
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Food safety bills introduced in Virginia regarding FDA code updates and state protocols.Some support1 report
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USFDA confirmed compliance for Alembic Pharmaceuticals' bioequivalence facility located in Vadodara, Gujarat.Some support2 reports
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A routine inspection of a GMP manufacturing unit in Visakhapatnam, Andhra Pradesh, was conducted by the United States Food and Drug Administration and confirmed regulatory compliance.Some support1 report
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The US Food and Drug Administration conducted a cGMP inspection at a facility belonging to Cipla.Some support2 reports
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The US Food and Drug Administration conducted a routine cGMP inspection of a facility belonging to OneSource Specialty Pharma Limited.Some support1 report1 development inside
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USFDA conducted an inspection of Strides Pharma Science Limited's flagship manufacturing facility in Bengaluru, India.Some support1 report
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U.S. FDA granted final approval for Pitolisant Tablets, confirming its bioequivalence to Wakix®.Some support1 report
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The US Food and Drug Administration inspected a plant located in Raleigh, North Carolina.Some support1 report
Gone quiet
No new reports in 90+ days-
An inspection regarding API manufacturing standards was conducted at a facility in Srikakulam district, involving Aurobindo Pharma and Auroactive Pharma.Some support1 report
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The FDA has granted tentative approval for Lupin's drug application, noting its bioequivalence to Astellas' reference drug.Some support1 report
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The US Food and Drug Administration conducted an inspection in Anakapalli district, which is located in the state of Andhra Pradesh.Some support1 report
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The United States Food and Drug Administration inspected a Formulation facility in Sangareddy District, resulting in OAI status.Some support2 reports
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Explainers that pass through United States Food and Drug Administration
United States Food and Drug Administration is a step on the way to someone elseAround United States Food and Drug Administration this week
News at the entities that move United States Food and Drug Administration most-
Wockhardt StructuralEureka Forbes, Marico, and Wockhardt reported their recent financial results, showing varied performance across the companies.Moves United States Food and Drug Administration
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Cipla StructuralGeopolitical instability is causing cost inflation and supply chain disruptions, impacting pharmaceutical companies like Cipla and Biocon.Moves United States Food and Drug Administration
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Virginia StructuralJudge Martin entered an order in a Virginia court, subjecting the Commonwealth of Virginia to an injunction.Moves United States Food and Drug Administration
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Mesoblast StructuralMesoblast received FDA approval for a specific product on June 1st, led by CEO Silviu Itescu.Moves United States Food and Drug Administration
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GMP StructuralKlemm discussed funding for a City Park project, and GMP provided construction packages for the initiative.Moves United States Food and Drug Administration
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Aurobindo Pharma StructuralMultiple Indian companies, including Dabur, Lenskart, and Aurobindo Pharma, reported strong profit and revenue growth in May 2026.Moves United States Food and Drug Administration
Connections
The 16 strongest of 579, analyzed from the reporting. The bars show how strongly a change on one side reaches the other.-
Cipla Structural
USFDA conducts cGMP inspections at Cipla facilities as part of regulatory oversight.
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Wockhardt Structural
Wockhardt achieved NCE approval from the United States Food and Drug Administration.
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Virginia Structural
FDA food code updates establish standards that influence and govern state-level operational protocols in Virginia.
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Mesoblast Structural
The US FDA formally granted RMAT designation to Mesoblast, establishing a regulatory oversight relationship.
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GMP Structural
The FDA exercises mandatory oversight over GMP, requiring routine inspections to ensure regulatory compliance.
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Aurobindo Pharma Structural
US FDA conducts inspections of Aurobindo Pharma subsidiaries as part of regulatory oversight.
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AbbVie Structural
AbbVie's ability to market drugs depends on formal regulatory approval from the United States Food and Drug Administration.
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Formulation Structural
Formulation is subject to inspection and regulatory oversight by the USFDA, which determines operational status.
Show all 16 connections
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East Brunswick Structural
The FDA conducted a regulatory inspection of an acquired facility located in East Brunswick.
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Srikakulam Shared context
The US FDA conducted an inspection of a subsidiary located in Srikakulam.
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Goa Shared context
The FDA conducted a regulatory inspection at a facility located in Goa.
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North Carolina Structural
The USFDA conducts regulatory inspections within North Carolina's jurisdiction.
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Telangana Shared context
The USFDA conducts regulatory inspections within the geographical context of Telangana.
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Gavin Newsom Shared context
State legislation referenced FDA-approved ingredients when considering ingredient bans.
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Anakapalli district Shared context
The US FDA performed an inspection while operating within the Anakapalli district.
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Satara Shared context
The FDA conducted an inspection of a manufacturing facility located in Satara.
History
Events by the month they beganNovember 2026
2 eventsOctober 2026
3 events- USFDA conducted a Pre-Approval Inspection of Gufic Biosciences Limited's manufacturing facility located in Pithampur.
- Dr. Reddy's Laboratories' manufacturing facility in Visakhapatnam underwent a USFDA pre-approval inspection.
- FDA inspected manufacturing facilities in Satara and East Brunswick on October 9, 2026.
September 2026
7 events- FDA gave tentative approval to Lupin for an alternative formulation of a Bristol-Myers Squibb drug, which Lupin plans to manufacture in Somerset.
- FDA inspection at Unichem Laboratories Limited's Goa facility found procedural enhancements needed, leading to market reaction.
- AbbVie and Cerevel Therapeutics successfully launched a new drug for Parkinson's disease, pending government coverage negotiations.
- Routine cGMP inspection found three observations at a Strides Pharma Science Limited manufacturing facility in Chennai.
- Food safety bills introduced in Virginia regarding FDA code updates and state protocols.
- USFDA confirmed compliance for Alembic Pharmaceuticals' bioequivalence facility located in Vadodara, Gujarat.
- A routine inspection of a GMP manufacturing unit in Visakhapatnam, Andhra Pradesh, was conducted by the United States Food and Drug Administration and confirmed regulatory compliance.
Show 3 earlier months
August 2026
4 events- The US Food and Drug Administration conducted a cGMP inspection at a facility belonging to Cipla.
- USFDA conducted an inspection of Strides Pharma Science Limited's flagship manufacturing facility in Bengaluru, India.
- U.S. FDA granted final approval for Pitolisant Tablets, confirming its bioequivalence to Wakix®.
- The US Food and Drug Administration inspected a plant located in Raleigh, North Carolina.
July 2026
2 eventsJune 2026
4 events- An inspection regarding API manufacturing standards was conducted at a facility in Srikakulam district, involving Aurobindo Pharma and Auroactive Pharma.
- The FDA has granted tentative approval for Lupin's drug application, noting its bioequivalence to Astellas' reference drug.
- The US Food and Drug Administration conducted an inspection in Anakapalli district, which is located in the state of Andhra Pradesh.
- The United States Food and Drug Administration inspected a Formulation facility in Sangareddy District, resulting in OAI status.