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Browse APIsSourcing Guide
438APIs listed
60Approved peptides
35FDA shortage
10EMA / MHRA cited

How it works

Clinical API Coordination

We coordinate sourcing through a network of licensed wholesalers and manufacturers. Every listing is an ingredient found in a product approved by FDA, EMA or MHRA, and each one links to the approval record. Controlled substances are not listed.

Approval-Referenced Listings

Each API links to its approval record on Drugs@FDA, DailyMed, an EMA EPAR, or a UK SmPC on the eMC, plus its PubChem CAS record.

Documentation on Request

Ask for the supplier's Certificate of Analysis, a DMF letter of authorization where one exists, and the monograph grade with your inquiry.

Shortage-Aware

Listings whose finished products are on FDA's shortage list carry a Shortage tag, checked against FDA's database on October 14, 2026.

Catalog

API Catalog (A–Z)

Select Details on any listing to see its approval references and status. Tags: FDA / EMA / MHRA show who approved it (each links to the record). Shortage means on FDA's current shortage list. First generic and New approval are from FDA's 2025–2026 lists. WHO EML means on the WHO Model List of Essential Medicines. Ex-US means approved outside the U.S. only. Peptide marks approved peptide APIs, including peptide-based biologics.

Pending FDA approval

Applications pending at FDA

Not yet FDA-approved, as of Oct 14, 2026.

Regulatory facts only, from the linked sponsor, SEC or ClinicalTrials.gov source. Dates are shown as the source states them. These entries are not counted in the APIs listed total.

Under FDA review

Cagrilintide + semaglutide (CagriSema)

Not FDA-approvedPeptide
Sponsor
Novo Nordisk
Type
Peptide
Status
NDA submitted Dec 18, 2025
Date
No public PDUFA date; sponsor guides to a U.S. decision in Q4 2026

Source

Lorundrostat

Not FDA-approved
Sponsor
Mineralys Therapeutics
Type
Small molecule
Status
NDA accepted Mar 2026
Date
PDUFA Dec 22, 2026

Source

Relacorilant

Not FDA-approved
Sponsor
Corcept Therapeutics
Type
Small molecule
Status
NDA resubmitted Jun 17, 2026
Date
PDUFA Dec 17, 2026

Source

Bezuclastinib

Not FDA-approved
Sponsor
Cogent Biosciences
Type
Small molecule
Status
Three NDAs under review
Date
PDUFA Nov 30, 2026; Dec 30, 2026; Jun 29, 2027

Source

Reboxetine (AXS-12)

Not FDA-approved
Sponsor
Axsome Therapeutics
Type
Small molecule
Status
NDA accepted Jul 2026
Date
PDUFA May 1, 2027

Source

Encaleret

Not FDA-approved
Sponsor
BridgeBio Pharma
Type
Small molecule
Status
NDA accepted Jul 2026
Date
PDUFA May 8, 2027

Source

Bimatoprost grenod (NCX 470)

Not FDA-approved
Sponsor
Nicox / Kowa
Type
Small molecule
Status
NDA accepted Aug 2026
Date
PDUFA Apr 30, 2027

Source

Zalunfiban

Not FDA-approved
Sponsor
CeleCor Therapeutics
Type
Small molecule
Status
NDA accepted Sep 2026
Date
PDUFA Jun 18, 2027

Source

Phase 3 peptides (not yet submitted)

Retatrutide

Not FDA-approvedPeptide
Sponsor
Eli Lilly
Type
Peptide
Status
Phase 3 reported; not submitted
Date
Sponsor plans submission in Q1 2027

Source

Survodutide

Not FDA-approvedPeptide
Sponsor
Boehringer Ingelheim (with Zealand Pharma)
Type
Peptide
Status
Phase 3 trials completed; no filing announced
Date
No date announced

Source

Maridebart cafraglutide (MariTide)

Not FDA-approvedPeptide
Sponsor
Amgen
Type
Peptide–antibody conjugate
Status
Phase 3 active, not recruiting
Date
No date announced

Source

Amycretin

Not FDA-approvedPeptide
Sponsor
Novo Nordisk
Type
Peptide
Status
Phase 3 recruiting
Date
No date announced

Source

Regulatory Watch · Checked October 14, 2026

What Changed Recently

FDA Novel Approvals

  • Orforglipron (Foundayo), April 1, 2026
  • Linerixibat (Lynavoy), March 17, 2026
  • Baxdrostat (Baxfendy), May 15, 2026
  • Tebipenem pivoxil (Utebzi), June 17, 2026
  • Camizestrant (Etcamah), September 4, 2026
  • Tavapadon (Juvmo), September 25, 2026
  • Pritelivir (Hovilpri), October 9, 2026

FDA lists 46 novel approvals for 2025 and 46 so far in 2026. FDA 2026 · FDA 2025

First Generics, 2026

  • Dapagliflozin, April 6
  • Canagliflozin, April 14
  • Enzalutamide, April 20
  • Venetoclax, May 15
  • Bosutinib, June 12
  • Baloxavir marboxil and fostamatinib, June 17
  • Afatinib, July 14
  • Cabozantinib, August 14

An approved first generic is not necessarily on the market yet; patents and exclusivity still apply. FDA First Generic Drug Approvals

FDA Shortage List

35 catalog APIs are in finished products listed as Currently in Shortage. Most are injectables, for example heparin, lidocaine, bupivacaine, ropivacaine, dexamethasone sodium phosphate, carboplatin, methotrexate, furosemide and rocuronium.

The list changes often, so check it often. FDA Drug Shortages

Sourcing Guide

API Sourcing Basics

A short regulatory primer for pharmacy and manufacturing teams. It is not legal advice. Use the linked primary sources for decisions.

Drug Master Files (DMFs)

A DMF is a submission to FDA that holds confidential information about facilities, processes or articles used in making human drugs. FDA says DMFs are not required by statute or regulation and are neither approved nor disapproved. FDA reviews a DMF's technical content when an application (NDA, ANDA, IND, BLA) references it. API manufacturers usually file Type II DMFs. When you send an inquiry, ask whether a DMF exists and whether a letter of authorization is available.

FDA: Drug Master Files · FDA DMF list

Certificates of Analysis (CoAs) and Component Testing

A CoA reports the supplier's test results for a specific lot. Under FDA's CGMP rules for finished pharmaceuticals (21 CFR 211.84), manufacturers must test or examine incoming components. They may rely on a supplier's report of analysis only if they run at least one identity test of their own and periodically validate the supplier's results. Check that the CoA lot number matches the container label and names the monograph it was tested against.

21 CFR 211.84 (eCFR)

USP–NF Monographs

A USP–NF monograph sets the identity, strength, quality and purity tests for a substance. Under section 503A, a bulk drug substance must meet an applicable USP or NF monograph if one exists. Monographs are subscription content, so confirm the current official text with USP before you specify a grade.

FDA: Bulk Drug Substances Used in Compounding · USP–NF

503A versus 503B
  • 503A (state-licensed pharmacists and physicians): bulk substances must meet an applicable USP/NF monograph if one exists. If no monograph exists, the substance must be a component of an FDA-approved drug; if neither applies, it must be on FDA's 503A bulks list.
  • 503B (outsourcing facilities registered with FDA): bulk substances may be used only for drugs on FDA's shortage list at the time of compounding, distribution and dispensing, or if they appear on FDA's 503B bulks list. Outsourcing facilities must follow CGMP and are inspected by FDA on a risk-based schedule.

FDA: Bulk Drug Substances · FDA: Outsourcing Facilities · FDA safety-risk list (substances on it are excluded from this catalog)

GMP for APIs (ICH Q7)

ICH Q7, adopted by FDA as guidance, is the international GMP standard for manufacturing active pharmaceutical ingredients. Ask suppliers for their most recent inspection or audit status.

FDA: ICH Q7 guidance

Verifying Approvals Worldwide
Supply-Chain Traceability (DSCSA)

The Drug Supply Chain Security Act sets U.S. requirements for tracing prescription drug products through distribution. Ask partners how they handle DSCSA requirements for finished products.

FDA: DSCSA

Can I Request an Unlisted API?

Yes. Email the API name, CAS, grade and quantity to api@apiwholesaler.com. Requests are limited to licensed organizations. Controlled substances are not coordinated through this catalog.

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