Pharma company FDA records

One rule applies to all 53 companies: the main business is prescription drugs or biologics, the group reports on its own, and revenue for its most recent completed fiscal year is at least US$3.0 billion. That year is calendar 2025 for December reporters and the year to March 2026 for Japanese and Indian groups with a March year end. The 24 largest are taken from Fierce Pharma's 2025 top 20 plus the four it names next; every other figure is from SEC filings (XBRL company facts) or the company's own results release, linked on each company page.

Foreign currency is converted at an approximate average rate, stated beside each figure, and a company is listed only if it still clears US$3.0 billion with its currency 5% weaker. Those rates are our assumption, not a published figure. A company with no FDA record under its own name in these sources is left off, because its page would be empty. The Tokyo-listed subsidiaries Chugai and Kyowa Kirin are counted as their own companies, apart from Roche and Kirin.

Considered and left off:

FDA names the firm on every record in its own way: "Pfizer Inc.", "Hospira, Inc.", "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.". A record belongs to a company when the firm name contains that company's name or the name of a subsidiary it owns today, as whole words, or equals a short name we reviewed one by one (such as "Lilly" or "Merck" in Drugs@FDA). A record is counted under the entity FDA names, for all dates, so a record from before an acquisition is counted with the current owner. A name that two companies could claim is left out of both, so counts can be lower than a company's true total.

The full matching table is a CSV. These are the names we left out on purpose:

Approvals

Original NDA and BLA applications with an approved original submission in Drugs@FDA, counted by the approval date. Drugs@FDA lists the company that holds the application today, not the one that held it at approval. It covers many, not all, therapeutic biologics, so BLA counts are incomplete. Supplements, tentative approvals and generic (ANDA) approvals are not counted. Applications of every kind count, including 505(b)(2) and older molecules, so this is not a count of new molecular entities. Source: Original NDA and BLA approvals. openFDA Drugs@FDA, collected daily.

Complete response letters

Letters FDA has published in the openFDA transparency dataset. FDA released more than 200 letters on 10 July 2025, all from 2020 to 2024 and all for products later approved. It added 89 letters for applications that were not approved on 4 September 2025 and says it now publishes new letters promptly. Years before 2025 therefore hold only some of the letters FDA sent, and a count of zero does not mean no letter was issued. Source: Complete response letters. openFDA transparency CRL dataset, collected daily.

Warning letters

Warning letters from CDER, CDRH and CBER on FDA's site, from a saved snapshot of FDA's pages that FDA's own site does not offer as data. Tobacco, food and veterinary letters are excluded. Coverage starts in 2017. A letter is counted under the firm name it was addressed to, so letters to a contract site that does not carry the company's name are not attributed. Letters about drug promotion also appear in the OPDP count. Source: Warning letters. FDA warning letter pages, snapshot refreshed weekly.

OPDP letters

Untitled letters and warning letters from FDA's Office of Prescription Drug Promotion, from May 2017. They concern specific promotional pieces. A promotion warning letter can appear both here and in the warning letter count, so the two counts are not added together. Source: OPDP untitled and warning letters. FDA OPDP letter pages, snapshot refreshed weekly.

Drug recalls

Human drug recalls in FDA's enforcement reports through openFDA, counted once per recall event by initiation date. One event can cover many products and lots. Device recalls are not counted, so a company that also makes devices is shown for its drugs only. FDA's class describes the recall's risk, and FDA classifies a recall after the firm starts it. Source: Drug recall events. openFDA drug enforcement reports, collected daily.

Inspections

Drug and biologic inspections that FDA has classified, from the FDA Data Dashboard, by FDA fiscal year (1 October to 30 September). An inspection that covers several project areas is counted once at its most serious classification. The counts include clinical investigator and bioresearch monitoring inspections, blood and plasma centers and sites abroad, so a plasma business shows many inspections. NAI is no action indicated, VAI voluntary action indicated and OAI official action indicated. Device inspections are not counted. Source: Inspections classified. FDA Data Dashboard, collected daily.

Debarments

FDA's debarment lists name individuals, not companies, so no listed company has a debarment record here.