Suppliers and packagers for generic pharmaceutical drug: APREMILAST

APREMILAST

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437	NDA	Amgen, Inc	55513-137-60	60 TABLET, FILM COATED in 1 BOTTLE (55513-137-60)	2020-02-26
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437	NDA	Amgen, Inc	55513-137-95	1 BLISTER PACK in 1 CARTON (55513-137-95) / 28 TABLET, FILM COATED in 1 BLISTER PACK	2020-02-26
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437	NDA	Amgen, Inc	55513-369-55	1 BLISTER PACK in 1 CARTON (55513-369-55) / 1 KIT in 1 BLISTER PACK	2020-02-26
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437	NDA	Amgen, Inc	55513-485-96	5 BLISTER PACK in 1 CARTON (55513-485-96) / 1 KIT in 1 BLISTER PACK (55513-485-95)	2020-02-26

Suppliers and packagers for generic pharmaceutical drug: APREMILAST

Last updated: May 25, 2026

Apremilast Suppliers: API Manufacturers, Contract Fill-Finish, and Key Raw-Material Sources for Otezla

Apremilast supply chains split into (1) active pharmaceutical ingredient (API) manufacture, (2) formulation excipients and packaging, and (3) contract manufacturing and fill-finish for Otezla tablets. The practical supplier set depends on the Otezla NDA/ANDA manufacturing network used for each strength (10 mg, 20 mg, 30 mg) and each market, with major commercial production historically tied to Celgene/Bristol Myers Squibb’s downstream tablet supply and incumbent API sources.

Who supplies apremilast API and how is the supply chain structured?

API manufacturing nodes: what to map in sourcing

A complete apremilast supplier map should be built across:

• API synthesis sites (apremilast active ingredient)
• Intermediates and key starting materials used to build the pyrrolopyridine scaffold
• Re-crystallization / purification step providers (often performed at or near the API site)
• Regulated quality systems (GMP compliance, DMF/CEP coverage, batch release testing)

Contract manufacturing vs. in-house tablet production

Apremilast tablets sold as Otezla are manufactured by NDA/marketing authorization holders and their contract manufacturing organizations. The supplier “answer” in procurement terms is the set of manufacturers listed on:

• Regulatory dossiers (DMF references for API; manufacturing site listings for drug product)
• FDA inspection histories for listed facilities
• Labeler/manufacturer fields and supply announcements tied to each lot

What suppliers matter most for apremilast availability risk

For continuity, the most scrutinized supplier categories are:

• API site availability (capacity shutdown risk)
• Single-source intermediates (late-stage intermediate bottlenecks)
• Drug product tablet compression and coating line availability (for consistent dissolution and exposure)
• Packaging sub-suppliers for blister and bottle formats

Which companies are apremilast API suppliers for Otezla?

How to identify legitimate apremilast API suppliers

In practice, “suppliers” are verified via:

• Drug Master File (DMF) holders and referenced synthesis processes
• FDA facility registrations tied to apremilast API manufacture
• Commercial packaging labels linking to the drug product manufacturer, then working backward to the API DMF network

Incumbent ownership and commercial control

Apremilast is commercialized as Otezla by Bristol Myers Squibb (successor to Celgene). That incumbency shapes supplier selection:

• API is sourced from qualified vendors supporting the approved DMF process
• Tablet manufacturing is executed by BMS and/or its qualified contract manufacturers
• Supply tends to remain stable unless there are technical transfers, capacity events, or regulatory changes

What contract manufacturers make apremilast tablets and who does fill-finish?

What to check on labeling and regulatory records

Apremilast tablet suppliers for procurement are commonly disclosed via:

• Drug product label “manufactured for” or “manufactured by” fields
• GMP site addresses appearing on cartons and prescribing information
• FDA facility inspections aligned to tablet dosage form manufacture

Strength-specific manufacturing

Supply for 10 mg, 20 mg, and 30 mg tablets may involve:

• The same manufacturing site using different batch records and punch/formulation templates, or
• Different sites depending on capacity and historic batch allocation

The practical consequence for sourcing is that a “tablet manufacturer” can still be split by strength for lead-time planning.

Which excipient suppliers support apremilast tablet formulation?

Typical excipient categories used in solid oral tablets

Apremilast tablet formulations use standard solid oral excipient classes that can come from multiple suppliers:

• Cellulose-based binders and disintegrants
• Lactose or microcrystalline cellulose type carriers (varies by registered formulation)
• Film coating systems for tablet appearance and stability
• Colorants and inks (where applicable) with regulatory and supply continuity requirements

Procurement risk points

The constraint is usually not the binder itself but:

• Coating system components that drive coating weight uniformity and dissolution
• Colorant sourcing that can be sensitive to regulatory batches
• Global excipient qualification that slows swaps during shortages

What packaging suppliers are used for apremilast blister and bottle formats?

Packaging impacts on supply continuity

For apremilast, packaging suppliers matter because tablets are distributed globally and lot-level stability and traceability are required. Packaging categories to map include:

• Blister foil and backing film suppliers
• Hard bottle and cap suppliers
• Desiccant and induction seal components (if used)
• Printing and labeling component vendors

Where to source confirmed packaging vendors

Procurement-grade validation typically comes from:

• Approved packaging specs in regulatory filings
• Finished goods packaging lines listed in manufacturing records
• Lot packaging failure history and change-control logs

How does apremilast generic or biosimilar competition affect supplier selection?

Small-molecule: generics, not biosimilars

Apremilast is a small molecule. Competition affects supply via:

• API availability if generic entrants source the API from different qualified routes
• Dose form manufacturing capacity if multiple generic tablet makers bid for commodity excipients and packaging

Why generic entry can still stress the incumbent supply chain

Even when generics exist, drug product demand can rise quickly across multiple labelers, stressing:

• API upstream capacity
• Intermediate supply
• Packaging line availability for tablet blister/bottle products

When do apremilast exclusivity or patent events change supplier economics?

Procurement relevance

Patent and exclusivity timelines influence:

• The number of qualified API and tablet manufacturers
• The likelihood of technical transfers
• Contract pricing dynamics for API and drug product manufacture

What procurement teams do

When approaching major entry windows, buyers usually:

• Qualify second-source API and tablet sites
• Lock packaging supply
• Pre-negotiate change-control terms for analytical method transfer and stability commitments

What manufacturing/IP barriers can limit apremilast sourcing?

Barriers in practice

Common constraints include:

• DMF-proprietary synthesis routes and control of key intermediates
• Process-specific impurities and validated specifications
• Analytical method lock and reference standard dependencies
• Change control requirements for solid oral formulations

How those barriers show up during transitions

When new supply routes are introduced, timelines usually hinge on:

• Method transfer and system suitability
• Stability data generation and comparability analytics
• Regulatory acceptance of manufacturing site and process changes

Apremilast supplier landscape: what to build into a sourcing shortlist

Shortlist structure

A supplier shortlist should separate:

1. API supplier (GMP site) and its intermediary capability
2. Tablet manufacturer (GMP site) and strength coverage
3. Fill-finish and packaging lines (if subcontracted)
4. Excipient suppliers for coating and critical performance components
5. Primary packaging (blister/bottle) and closure/label component vendors

Due diligence package

For each shortlisted supplier, procurement typically validates:

• Facility GMP status and inspection outcomes
• History of batch deviations for similar products
• Ability to supply required strengths without cross-contamination controls gaps
• Lead times and allocation behavior during shortages

Key Takeaways

• Apremilast supply is best understood as an integrated network spanning API production, tablet manufacturing, and packaging.
• Procurement-grade supplier selection depends on confirmed manufacturing site listings tied to FDA/regulatory records and commercial labeling for each strength.
• The highest supply risk concentrates in single-source API/intermediate steps, followed by tablet line capacity and critical excipient/coating components.

FAQs

1. What is the difference between apremilast API suppliers and apremilast tablet manufacturers?
   API suppliers produce apremilast active ingredient; tablet manufacturers produce and release the finished solid oral dosage form using qualified formulation and packaging systems.

2. How can buyers confirm which facilities manufacture apremilast tablets?
   By using label manufacturing statements and mapping those sites to FDA-registered drug product manufacturing facilities and inspection records.

3. What upstream inputs are most critical for apremilast continuity?
   Late-stage intermediates and purification steps in the API synthesis route, plus tablet coating-related excipients that affect performance specs.

4. Do generic entrants change the apremilast supplier base?
   They can expand qualified API and tablet manufacturing capacity, but they also can increase overall demand that stresses the same upstream supply constraints.

5. What sourcing strategy reduces apremilast supply disruption risk?
   Qualify at least two independent API sites, secure secondary tablet manufacturing capacity, and lock packaging supply for the exact blister/bottle configuration used in distribution.

References

1. U.S. FDA. Drug approval reports and labeling for Otezla (apremilast).
2. U.S. FDA. Drugs@FDA records for Otezla (apremilast) and associated regulatory documents.
3. U.S. FDA. NDC labeler/manufacturer and facility registration resources related to apremilast drug product manufacturing sites.
4. FDA. Public FDA inspection and enforcement records applicable to listed manufacturing facilities for oral solid dose products.