HIGHOutside partySupplier
single-source API per product
“10-K Item 1A: 'we qualify only a single source of API for use in each product due to the cost and time required to validate and qualify a second source of supply'”
ANIP · Concentration risk · 10-K extracted
ANI Pharmaceuticals (ANIP) concentration risks
Updated
The most significant concentration ANI Pharmaceuticals discloses is single-source API per product, classified HIGH by disclosed size. Below: the full set from the latest 10-K — verbatim quotes, filing references, and a synthesis of what these exposures mean together.
Model-generated analysis — not investment advice. Not a registered investment advisor. Past performance does not guarantee future results.
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Source: ANI Pharmaceuticals’s SEC Form 10-K filed — view the filing on SEC EDGAR ↗
At a glance
Disclosed-size breakdown · 3 disclosed concentrations
HIGH2
MEDIUM1
LOW0
Disclosed concentrations
Each card carries a disclosed-size chip (HIGH / MEDIUM / LOW — how large the exposure is as a share of revenue, not how dangerous it is) and a nature tag: Built-in(the company’s own model, geography, or products) or Outside party (an external customer, supplier, or distributor it relies on).
HIGHOutside partySupplier
Cortrophin Gel and ILUVIEN contract manufacturers
“10-K Item 1: 'We do not have in-house manufacturing capabilities for the production of Cortrophin Gel or ILUVIEN, and thus we depend, and expect to continue to depend, exclusively on third-party contract manufacturers'”
MEDIUMBuilt-in & outside partyProduct / Revenue mix
Cortrophin Gel
“10-K Item 1A: 'a significant portion of our net product revenues were derived from the sale of Cotrophin Gel...sales of Cortrophin Gel will continue to account for a significant portion of our net product revenues'”
TrendMatrix Research · concentration synthesis
What these concentrations mean together
updated 2026-06-24The company's concentration profile is dominated by supply-chain dependencies that operate at multiple levels, with a product dependency layered alongside. The most pervasive supplier exposure is the practice of qualifying only a single source of active pharmaceutical ingredient (API) per product — a high-share dependency by disclosed size where the cost and time required to validate a second source means each commercial product is effectively tethered to one API supplier without a ready alternative if that supplier encounters regulatory action, capacity constraints, or supply disruption. Compounding the API dependency is a manufacturing concentration for key products: the company lacks in-house manufacturing for Cortrophin Gel and ILUVIEN and depends exclusively on third-party contract manufacturers for both — also a high-share dependency. The exclusive reliance on external CMOs for these specific products means any disruption at those facilities — a warning letter, a quality hold, or a force majeure event — would directly affect the ability to supply commercially important products. The product dependency on Cortrophin Gel adds a demand-side dimension: a significant portion of net product revenues were derived from Cortrophin Gel sales and the filing expects that concentration to continue, a moderate-share exposure in character that is mixed between structural (reflecting the company's branded product strategy) and dependency (tied to a single product franchise's commercial trajectory). Together, the API, CMO, and Cortrophin Gel dependencies describe a profile where supply and revenue concentration run in parallel, and a disruption to the Cortrophin Gel supply chain would simultaneously stress the most important revenue source.
For the engine’s reasoning on ANIP’s current verdict — including which dimensions drove the score — see the per-dimension breakdown.
Industry peers · Drug Manufacturers - Specialty & Generic
Peer concentration profile
| Symbol | Name | HIGH | MEDIUM | LOW | Total |
|---|---|---|---|---|---|
| ANIP● | ANI Pharmaceuticals, Inc. | 2 | 1 | 0 | 3 |
| BHC | Bausch Health Companies Inc. | 2 | 1 | 0 | 3 |
| AMLX | Amylyx Pharmaceuticals, Inc. | 2 | 0 | 0 | 2 |
| AMRX | Amneal Pharmaceuticals, Inc. | 1 | 1 | 0 | 2 |
| BCRX | BioCryst Pharmaceuticals, Inc. | 0 | 2 | 0 | 2 |
| ALKS | Alkermes plc | 0 | 1 | 1 | 2 |
Concentration counts reflect items disclosed in each peer’s most recent 10-K; disclosed-size classification uses TrendMatrix’s internal 10-K extraction taxonomy.