Suppliers and packagers for AFINITOR

AFINITOR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334	NDA	Novartis Pharmaceuticals Corporation	0078-0566-51	28 BLISTER PACK in 1 CARTON (0078-0566-51) / 1 TABLET in 1 BLISTER PACK (0078-0566-61)	2009-03-31
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334	NDA	Novartis Pharmaceuticals Corporation	0078-0567-51	28 BLISTER PACK in 1 CARTON (0078-0567-51) / 1 TABLET in 1 BLISTER PACK (0078-0567-61)	2009-03-31
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334	NDA	Novartis Pharmaceuticals Corporation	0078-0594-51	28 BLISTER PACK in 1 CARTON (0078-0594-51) / 1 TABLET in 1 BLISTER PACK (0078-0594-61)	2010-07-09
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334	NDA	Novartis Pharmaceuticals Corporation	0078-0620-51	28 BLISTER PACK in 1 CARTON (0078-0620-51) / 1 TABLET in 1 BLISTER PACK (0078-0620-61)	2011-07-29

AFINITOR API and Excipient Suppliers

Last updated: February 19, 2026

This report details identified suppliers of the active pharmaceutical ingredient (API) everolimus and key excipients utilized in the formulation of AFINITOR (everolimus tablets). Data is derived from patent filings, regulatory disclosures, and publicly available manufacturing information.

Who Manufactures Everolimus API?

The primary manufacturer of the everolimus API is Novartis AG. Novartis holds the originating New Drug Application (NDA) for AFINITOR and maintains control over its manufacturing supply chain.

• Novartis AG: Operates its own API manufacturing facilities. Specific sites involved in everolimus API production are not publicly disclosed, but global manufacturing networks are leveraged.

While Novartis is the primary source, the complexity of pharmaceutical supply chains can involve contract manufacturing organizations (CMOs) that produce API on behalf of the innovator company under strict quality agreements. However, public disclosures do not pinpoint specific CMOs for everolimus API.

What Excipients are Used in AFINITOR?

AFINITOR tablets are formulated with a specific set of inactive ingredients (excipients) that are critical for drug delivery, stability, and manufacturing. Identifying these excipients provides insight into potential secondary suppliers for the formulation process.

The primary excipients listed in the U.S. Prescribing Information for AFINITOR include:

• Butylated Hydroxyanisole (BHA): An antioxidant.
• Butylated Hydroxytoluene (BHT): Another antioxidant.
• Hypromellose: A binder and film-coating agent.
• Lactose Monohydrate: A filler and binder.
• Magnesium Stearate: A lubricant.
• Microcrystalline Cellulose: A filler and binder.
• Povidone: A binder.

Which Companies Supply Key Excipients?

The supply of pharmaceutical-grade excipients is typically fragmented and involves multiple global manufacturers. Companies supplying these materials to Novartis or its contract manufacturers for AFINITOR formulation include those with broad portfolios of high-purity ingredients.

Antioxidant Suppliers (BHA, BHT)

BHA and BHT are commonly used antioxidants in the pharmaceutical industry. Major chemical manufacturers and specialized excipient suppliers produce these compounds.

• Merck KGaA: Offers a range of antioxidants, including BHA and BHT, under its MilliporeSigma brand. Their products meet stringent pharmaceutical quality standards.
• BASF SE: A global chemical company that produces a wide array of ingredients, including antioxidants for pharmaceutical applications.
• Eastman Chemical Company: Supplies antioxidants used in various industries, including pharmaceuticals.

Binder and Filler Suppliers (Hypromellose, Lactose Monohydrate, Microcrystalline Cellulose, Povidone)

These excipients are foundational in tablet formulation, and their supply is robust.

Hypromellose (Hydroxypropyl Methylcellulose - HPMC)

• Ashland Global Holdings Inc.: A significant supplier of cellulose derivatives, including hypromellose, under brands like VIVAPHARM®.
• Dow Inc.: Manufactures various cellulose ethers, including hypromellose, for pharmaceutical use.
• Shin-Etsu Chemical Co., Ltd.: A major producer of cellulose derivatives for pharmaceutical applications globally.

Lactose Monohydrate

• DMV-Fonterra Excipients (now part of Kerry Group): A leading global supplier of lactose-based excipients for the pharmaceutical industry.
• Borculo Domo Ingredients (part of FrieslandCampina): Another significant producer of pharmaceutical-grade lactose.
• Meggle GmbH & Co. KG: A well-established supplier of lactose and other functional ingredients for pharmaceuticals.

Microcrystalline Cellulose (MCC)

• FMC Corporation: A primary global supplier of microcrystalline cellulose, including its PHARMACEL® brand, widely used as a binder and filler.
• JRS Pharma (part of J. Rettenmaier & Söhne): Offers a portfolio of cellulose-based excipients, including MCC.
• Blanver Farmoquímica Ltda.: A Brazilian pharmaceutical company that also manufactures and supplies MCC.

Povidone (Polyvinylpyrrolidone - PVP)

• Ashland Global Holdings Inc.: A major supplier of povidone under the Plasdone® brand, a widely recognized pharmaceutical excipient.
• BASF SE: Also produces povidone (e.g., Kollidon®) for pharmaceutical applications.
• Sigma-Aldrich (part of Merck KGaA): Offers a range of povidone grades for research and pharmaceutical manufacturing.

Lubricant Suppliers (Magnesium Stearate)

Magnesium stearate is a common lubricant essential for tablet manufacturing.

• Godrej Industries Limited (Chemicals Division): A significant producer of oleochemicals, including magnesium stearate, for the pharmaceutical sector.
• Norwegian Finse: A supplier of high-purity magnesium stearate.
• Mallinckrodt Pharmaceuticals: While primarily a pharmaceutical company, they also supply pharmaceutical ingredients, including magnesium stearate.

Regulatory Landscape for API and Excipient Sourcing

The sourcing of both API and excipients for AFINITOR is governed by stringent regulatory frameworks, primarily established by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

• Good Manufacturing Practices (GMP): All manufacturing facilities producing the API and excipients must adhere to cGMP regulations. This ensures consistent quality, purity, and safety of the materials.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and quality controls for the API. Novartis would reference these DMFs in its NDA for AFINITOR.
• Excipient Qualification: Pharmaceutical companies must qualify their excipient suppliers. This involves rigorous audits of the supplier's manufacturing sites, quality systems, and documentation to ensure the excipient meets pharmacopoeial standards (e.g., USP/NF, Ph. Eur.) and is suitable for its intended pharmaceutical use.
• Supply Chain Integrity: Regulations emphasize the need for robust supply chain management to prevent counterfeiting, contamination, and adulteration. This includes thorough vetting of all suppliers and a clear understanding of the origin and transit of all materials.
• Change Control: Any changes in the manufacturing process or sourcing of the API or key excipients require notification to regulatory agencies and may necessitate re-validation or supplemental filings with the NDA.

Patent Landscape and Generic Competition

The patent landscape surrounding everolimus and its formulations directly impacts supplier dynamics.

• Composition of Matter Patent: The primary patent for everolimus has expired in major markets, opening the door for generic manufacturers. This expiry is a key driver for the development of generic AFINITOR products.
• Formulation Patents: Patents covering specific formulations, including the combination and ratios of excipients used in AFINITOR, can extend market exclusivity. Generic manufacturers must design around these formulation patents to launch their products.
• Process Patents: Patents related to specific manufacturing processes for the API or the finished drug product can also influence competition.

The expiration of key patents for everolimus has led to increased interest from generic drug manufacturers. These companies will seek to establish their own supply chains for everolimus API and will need to identify and qualify suppliers for all necessary excipients, potentially increasing demand for these materials from a broader base of pharmaceutical companies.

Conclusion

Novartis AG is the primary manufacturer of everolimus API for AFINITOR. The formulation utilizes standard pharmaceutical excipients including antioxidants (BHA, BHT), binders/fillers (hypromellose, lactose monohydrate, microcrystalline cellulose, povidone), and lubricants (magnesium stearate). A diverse range of global chemical and specialized excipient manufacturers supply these materials. Regulatory compliance through GMP, DMFs, and rigorous supplier qualification is paramount for all entities in the AFINITOR supply chain. The expiry of everolimus patents is driving generic competition, creating opportunities for new entrants to establish supply relationships with excipient providers.

Key Takeaways

• Novartis AG is the sole originator of everolimus API for AFINITOR.
• Key excipients include BHA, BHT, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.
• Suppliers for these excipients are numerous global chemical and pharmaceutical ingredient manufacturers.
• Regulatory compliance (cGMP, DMFs, supplier qualification) is critical across the entire supply chain.
• Patent expirations are facilitating generic entry, expanding the market for excipient suppliers.

Frequently Asked Questions

1. Can generic manufacturers source everolimus API from third-party suppliers instead of producing it in-house?

Yes, generic manufacturers typically source everolimus API from specialized API manufacturers, provided these suppliers can meet stringent regulatory requirements and quality standards.

2. How is the pharmaceutical grade of excipients confirmed?

Pharmaceutical-grade excipients are confirmed through adherence to pharmacopoeial standards (e.g., USP/NF, Ph. Eur.), robust quality control testing by the manufacturer, and rigorous qualification by the pharmaceutical company using the excipient.

3. What is the typical shelf life of pharmaceutical excipients like lactose monohydrate?

The shelf life of pharmaceutical excipients varies based on the specific material, its packaging, and storage conditions. Lactose monohydrate, when stored under appropriate conditions, typically has a shelf life of 2-5 years. Manufacturers provide specific expiry dates.

4. Are there any specific regional restrictions on the sourcing of these excipients?

While there are no blanket regional restrictions for these common excipients, specific countries may have import/export regulations or requirements for local registration of pharmaceutical ingredients. Regulatory compliance within the target market is always necessary.

5. How does the purity of magnesium stearate impact its use in tablet formulation?

The purity of magnesium stearate is critical. It must be free from heavy metals, organic impurities, and microbial contamination. Impurities can affect tablet dissolution, stability, and potentially lead to adverse patient effects. Pharmaceutical-grade magnesium stearate is essential.

Citations

[1] U.S. Food and Drug Administration. (n.d.). FDA Drug Approval Process. Retrieved from https://www.fda.gov/drugs/development-approval-process-drugs/fda-drug-approval-process [2] European Medicines Agency. (n.d.). How to apply for a medicine approval. Retrieved from https://www.ema.europa.eu/en/human-regulatory/overview/about-ema/how-ema-does-its-work/how-apply-medicine-approval [3] United States Pharmacopeia. (n.d.). USP-NF. Retrieved from https://www.usp.org/products/usp-nf [4] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. Retrieved from https://www.edqm.eu/en/european-pharmacopoeia-49 [5] AFINITOR (everolimus) tablets prescribing information. (2024). Novartis Pharmaceuticals Corporation.