Amphastar Pharmaceuticals, Inc.

Amphastar Pharmaceuticals, Inc. develops, manufactures, and commercializes injectable and inhalation pharmaceutical products, with a portfolio that includes both branded and generic medicines. The company also performs contract manufacturing services and has built capabilities across finished dosage forms, APIs, and certain starting materials. Its business is centered on complex sterile and specialty products such as glucagon, epinephrine, phytonadione, and BAQSIMI®, alongside development-stage candidates. Amphastar operates as a single reportable segment, pharmaceutical products, and relies on a mix of U.S. and China manufacturing assets to support supply and future pipeline expansion.

23,9 %

49,5 %

13,6 %

−1,7 %

4.02

2.90

— Amphastar Pharmaceuticals, Inc.
%
Branded pharmaceutical products55% Commercial branded medicines such as BAQSIMI®, glucagon, epinephrine, Primatene MIST®, and phytonadione.
Generic injectable products25% Sterile injectable medicines sold into hospital and retail channels, including products like enoxaparin and nitroprusside.
Inhalation products8% Respiratory products sold through pharmacy and healthcare distribution channels.
Contract manufacturing services7% Third-party manufacturing services recognized when products are shipped to customers.
APIs and starting materials5% Internal and external supply of APIs, intermediates, and starting materials used in finished products and pipeline manufacturing.

Amphastar sells primarily to wholesalers and distributors that then supply pharmacies, hospitals, and other end...

  • Wholesalers and pharmaceutical distributorsprimary

    Buy finished products in bulk for redistribution and are central to Amphastar's U.S. commercial model because they manage inventory, chargebacks, and downstream fulfillment.

  • Hospitals and healthcare systemsprimary

    Purchase injectable medicines used in acute care and procedural settings, where product availability and regulatory compliance matter.

  • Retail pharmacy channelsecondary

    Buys branded and OTC-adjacent products such as Primatene MIST® and BAQSIMI® for patient dispensing.

  • Third-party pharmaceutical manufacturerssecondary

    Use Amphastar's manufacturing capabilities for contract development and manufacturing services.

  • Patients and payerssecondary

    Influence demand for prescription products through coverage, co-pay support, and formulary access even though they are not direct purchasers.

Amphastar is headquartered in the United States and generates most of its business through U.S...

  • United States is the core market for sales, regulation, and manufacturing
  • China is a key manufacturing base for selected starting materials and APIs
  • Some future API production is planned to come from the China facility
  • Imported APIs and components create exposure to trade and tariff changes
  • Foreign subsidiary cash is not freely available to fund U.S. operations
  • U.S. FDA and DEA oversight shapes manufacturing and distribution requirements

Amphastar is focused on expanding its injectable and inhalation platform while integrating BAQSIMI® globally into its...

01
Expand manufacturing facilities and internal production capabilitiesmedium-term

Capacity, supply reliability, and cost control are central to a sterile injectable business with regulatory oversight and import exposure.

02
Grow BAQSIMI® and other commercial productsshort-term

BAQSIMI® adds branded revenue and can improve mix, but requires successful commercialization and milestone management.

03
Advance pipeline products and regulatory approvalsmedium-term

New launches are needed to offset product-level volatility and support longer-term growth.

04
Pursue strategic acquisitionsmedium-term

Acquisitions can add technologies, manufacturing know-how, and commercial assets faster than organic development alone.

Amphastar faces meaningful concentration and execution risk around a relatively small set of commercial products, where...

high

Manufacturing disruption in China

A portion of manufacturing takes place in China, including starting materials and APIs for several products, so plant disruption or political/trade changes could interrupt supply and raise costs.

Scope
China facility and imported inputs
Materiality
high
high

Product sales volatility and competition

Management noted that glucagon, epinephrine, and other products can fluctuate based on competitive dynamics and competitor supply, which can quickly affect revenue mix.

Scope
Commercial injectable portfolio
Materiality
high
high

Regulatory compliance and inspection risk

FDA and DEA oversight of formulation, manufacture, distribution, packaging, and labeling means any compliance issue can disrupt production or trigger remediation costs.

Scope
U.S. and China manufacturing sites
Materiality
high
medium

Tariff and trade policy exposure

The company imports APIs, starting materials, and components from various countries, so tariffs or trade restrictions can increase input costs and complicate sourcing.

Scope
Global supply chain
Materiality
medium
medium

Cybersecurity and data loss

A security incident could disrupt operations, compromise clinical or commercial data, and create legal and reputational harm.

Scope
Internal systems and third-party providers
Materiality
medium
Revenue deductions and net sales estimates
Affects net revenue, receivables, and accrued liabilities
BAQSIMI® revenue recognition and TSA transition
Affects revenue comparability and gross margin
Intangible asset amortization and impairment
Affects operating income and balance sheet carrying value
Inventory and channel-related estimates
Affects revenue timing and accrued liabilities

: 11/08/2026