Pharma & API
Drug makers and generic suppliers, read through their filings, FDA drug shortages, recalls and approvals, tariff and FDA rules, and where US drug and ingredient imports come from.
- Companies covered
- 12
- Latest quarter filed
- Sep 27, 2026
- SEC filings, last 30 days
- 9
- Comment periods open
- 2
- SEC EDGAR read
- 22:46 UTC, Oct 23
The numbers
US government series, latest print and the change on a year earlier · Federal Reserve Bank of St. Louis (FRED)Ninety days of filings
Every SEC filing by the companies below, one row each · move across to read a dayFri, Oct 23, 2026
No filings by the covered companies
Jul 26 to Oct 23 · 44 filings, 2 in the last seven days · SEC EDGAR. Tall: quarterly and annual reports. Middle: current reports (8-K). Short: other forms. Red: an 8-K item that says something went wrong.
What changed
Filings by the companies below, last 30 days · SEC EDGAR- Oct 21Johnson & Johnson · 10-QQuarterly report
- Oct 20Vertex · 8-KDirector or officer change
- Oct 15AbbVie · 8-KDirector or officer change
- Oct 13Johnson & Johnson · 8-KQuarterly results
- Oct 13Merck · 8-KDirector or officer change
- Oct 8Viatris · 8-KSigned a material agreement; Other material event
- Oct 6Regeneron · 8-KSigned a material agreement; Quarterly results; more
- Oct 5AbbVie · 8-KQuarterly results
- Sep 30Regeneron · 8-KDirector or officer change
Rules and notices
Federal Register, last 45 days- Oct 13Notice · Health and Human Services DepartmentPostapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability
- Oct 9Notice · Health and Human Services DepartmentPar Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications
- Oct 9Notice · Health and Human Services DepartmentAmneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams
- Oct 6Notice · Health and Human Services DepartmentTeva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correction
- Oct 2Rule · Health and Human Services DepartmentGlobal Benchmark for Efficient Drug Pricing (GLOBE) Model
- Sep 25Notice · Health and Human Services DepartmentReauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
- Sep 24Notice · Commerce DepartmentForeign-Trade Zone (FTZ) 40, Notification of Proposed Production Activity; Olon USA LLC; (Active Pharmaceutical Ingredients); Concord, Ohio
- Sep 24Notice · Commerce DepartmentForeign-Trade Zone (FTZ) 272, Notification of Proposed Production Activity; Piramal Critical Care, Inc.; (Pharmaceutical Anesthetics); Bethlehem, Pennsylvania
- Sep 23Notice · Commerce DepartmentGuidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals and Associated Pharmaceutical Ingredients and Technical Corrections to the Harmonized Tariff Schedule of the United States for Duties Imposed Under Proclamation 11020
- Sep 18Notice · Health and Human Services DepartmentBiosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document
Matched by title against the industry’s terms; paperwork renewals and meeting notices left out · read 22:03 UTC, Oct 23
Who is exposed
Trailing twelve months to each company’s latest quarter, from its own XBRL filings · SEC EDGAR| Company | Quarter to | Revenue | Growth | Gross margin | Op. margin | Capex / revenue | Capex growth | Inventory days | Backlog |
|---|---|---|---|---|---|---|---|---|---|
| Eli Lilly LLYBranded drugs | Jun 30, 2026 | $79.7B | +49.6% | 83.4% | — | — | — | 463 | — |
| Johnson & Johnson JNJBranded drugs and devices | Sep 27, 2026 | $99.3B | +7.8% | 67.6% | — | 5.6% | +20.9% | 174 | — |
| Merck MRKBranded drugs and vaccines | Jun 30, 2026 | $66.6B | +4.6% | 73.0% | — | 5.9% | +2.4% | 126 | — |
| Pfizer PFEBranded drugs and vaccines | Jun 28, 2026 | $63.7B | -0.2% | 73.2% | — | 3.8% | -12.1% | 212 | — |
| AbbVie ABBVBranded drugs | Jun 30, 2026 | $64.4B | +10.4% | 71.5% | 26.2% | 2.0% | +24.2% | 102 | — |
| Bristol Myers Squibb BMYBranded drugs | Jun 30, 2026 | $49.2B | +3.1% | 70.2% | — | 2.7% | +1.4% | 68 | — |
| Amgen AMGNBiologics | Jun 30, 2026 | $38.1B | +9.1% | 69.5% | 30.0% | 6.0% | +63.6% | 195 | — |
| Gilead GILDAntivirals | Jun 30, 2026 | $30.5B | +5.5% | 79.6% | -8.2% | 2.0% | +22.0% | 115 | — |
| Regeneron REGNBiologics | Jun 30, 2026 | $15.5B | +9.3% | — | 24.7% | 5.9% | +3.5% | — | — |
| Vertex VRTXSpecialty drugs | Jun 30, 2026 | $12.6B | +10.2% | 86.0% | 38.0% | 3.9% | +43.3% | 365 | — |
| Viatris VTRSGenerics | Jun 30, 2026 | $14.7B | +4.4% | 34.8% | -0.6% | 2.6% | +20.2% | 149 | — |
| Teva TEVAGenerics | Jun 30, 2026 | $17.3B | +4.1% | 52.5% | 9.3% | 3.2% | +10.0% | 143 | — |
| Median of 12 with a current year | +6.7% | 71.5% | 24.7% | 3.8% |
Growth compares the latest twelve months with the twelve before. A quarter a company reports only inside a year-to-date total is the difference of the two totals it filed; a ratio is shown only when both sides cover the same four quarters. Backlog is remaining performance obligations, with its change on a year earlier. A dash means the company does not report that line.
Drug shortages
FDA drug shortage list · openFDA- Products in shortage now
- 1,142
- To be discontinued
- 450
- Oct 21Hospira, Inc., a Pfizer Company · Analgesia/AddictionMorphine Sulfate Injection: unavailable
- Oct 21Gland Pharma Limited · CardiovascularFurosemide Injection: unavailable, discontinuation of the manufacture of the drug
- Oct 21Hospira, Inc., a Pfizer Company · Analgesia/AddictionKetorolac Tromethamine Injection: unavailable
- Oct 21Hospira, Inc., a Pfizer Company · Endocrinology/MetabolismSodium Bicarbonate Injection: unavailable
- Oct 21Hospira, Inc., a Pfizer Company · AnesthesiaMidazolam Hydrochloride Injection: unavailable, demand increase for the drug
- Oct 21Hospira, Inc., a Pfizer Company · AnesthesiaBupivacaine Hydrochloride, Epinephrine Bitartrate Injection: unavailable
- Oct 21Hospira, Inc., a Pfizer Company · AnesthesiaEtomidate Injection: unavailable
- Oct 21Pfizer Inc. · RheumatologyMethylprednisolone Acetate Injection: unavailable, demand increase for the drug
Newest updates to products listed as unavailable; counts are package listings, not distinct drugs · read 18:45 UTC, Oct 23
Drug recalls
FDA enforcement reports, last 60 days · openFDA- Oct 14Class II · K.C. Pharmaceuticals, Inc.Sterile Lubricant Dry Eye Relief Eye Drops: Lack of Assurance of Sterility
- Oct 14Class II · Carolina Infusion, LLCQUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Oct 14Class II · Carolina Infusion, LLCTIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Oct 14Class II · Carolina Infusion, LLCTri-MIX (PAPAV/PHENTO/ALPROS): Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Oct 14Class II · Carolina Infusion, LLCTri-MIX (PAPAV/PHENTO/ALPROS): Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Oct 14Class II · Carolina Infusion, LLCTri-MIX (PAPAV/PHENTO/ALPROS): Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Oct 14Class II · K.C. Pharmaceuticals, Inc.Sterile EYE DROPS Advanced Relief: Lack of Assurance of Sterility
- Oct 14Class II · Cipla USA, Inc.Fosfomycin Tromethamine Granules for Oral Solution: Failed Impurities/Degradation Specifications
Class I is the FDA’s most serious recall class · read 18:45 UTC, Oct 23
What to watch
Comment deadlines and effective dates ahead · Federal Register- Nov 17Comments close · NoticeBiosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document
- Nov 25Comments close · NoticeReauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
- Nov 30Takes effect · RuleGlobal Benchmark for Efficient Drug Pricing (GLOBE) Model
Where US supply comes from
US imports, Jul 2026 · UN Comtrade- HS 3004Medicines in doses · $6.7B · -10.1% on a year earlierSwitzerland 15% · India 14% · Ireland 13%
- HS 3002Vaccines, blood and biologics · $7.9B · +10.6% on a year earlierIreland 20% · Germany 17% · Belgium 16%
- HS 2941Antibiotics · $42M · -43.0% on a year earlierChina 64% · Brazil 6% · Germany 6%
- HS 2933Drug ingredients (heterocyclic compounds) · $489M · -27.7% on a year earlierChina 23% · Ireland 19% · India 12%
ARCANE reporting
Published investigations that land on this pageNo published ARCANE article on pharma & api yet. The article runner commissions one for this page; it appears here once accepted.