COMPANY

Amphastar Pharmaceuticals

HQ: Rancho Cucamonga, CA (US office) source · amphastar.com ↗ · West Coast

Amphastar Pharmaceuticals, Inc is a biopharmaceutical company focused on developing, manufacturing, and marketing: • Injectable, intranasal, and inhalation products;. From company website Source · Oct 12, 2026

Keywords: intranasal

Location: Rancho Cucamonga, CA (US office) · source · Oct 15, 2026

Profile checked Oct 10, 2026

2FDA records (2 yrs)

Trial and FDA signals

FDA complete response letter Received an FDA complete response letter (BLA 761403, letter dated Feb 26, 2026). FDA BLA 761403 (Feb 26, 2026)
Evidence (1 event)
- Feb 26, 2026 · FDA BLA 761403
  CRL text (OCR, redacted by FDA; first 200 chars from "COMPLETE RESPONSE"): COMPLETE RESPONSE Amphastar Pharmaceuticals, Inc. Attention: Magda Albedrop, RAC-Drugs Senior Supervisor of the CMC and Submissions Group Regulatory Affairs Rancho Cucamonga, CA (street omitted)

Job counts as of Oct 18, 2026. All trial and FDA signals

Timeline

Jun 16, 2026 FDA FDA New indication / efficacy supplement: REXTOVY (naloxone hydrochloride) — NDA208969/2, Jun 16, 2026. Applicant at approval: Amphastar Pharmaceuticals, Inc. source ↗
Jan 12, 2026 Partnership Partnership / licensing: $2M (upfront, as published); deal value up to $14M (kept separate from upfront), announced Jan 12, 2026. Source: SEC filing. source ↗
Aug 12, 2025 Partnership Partnership / licensing: upfront $750,000 paid by the company to the licensor (in-licensing; not money received), announced Aug 12, 2025. Source: SEC filing. source ↗
Mar 17, 2025 FDA FDA New indication / efficacy supplement: BAQSIMI (glucagon) — NDA210134/4, Mar 17, 2025. Applicant at approval: Amphastar Pharmaceuticals, Inc. source ↗

Funding

Last 2 years.

Jan 12, 2026 Partnership / licensing: $2M (upfront, as published); deal value up to $14M (kept separate from upfront), announced Jan 12, 2026. Source: SEC filing. source ↗
Aug 12, 2025 Partnership / licensing: upfront $750,000 paid by the company to the licensor (in-licensing; not money received), announced Aug 12, 2025. Source: SEC filing. source ↗

FDA records (last 2 years)

Jun 16, 2026 FDA New indication / efficacy supplement: REXTOVY (naloxone hydrochloride) — NDA208969/2, Jun 16, 2026. Applicant at approval: Amphastar Pharmaceuticals, Inc. source ↗
Mar 17, 2025 FDA New indication / efficacy supplement: BAQSIMI (glucagon) — NDA210134/4, Mar 17, 2025. Applicant at approval: Amphastar Pharmaceuticals, Inc. source ↗