Suppliers and packagers for aklief

aklief

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527	NDA	Galderma Laboratories, L.P.	0299-5935-02	1 TUBE in 1 BLISTER PACK (0299-5935-02) / 2 g in 1 TUBE	2019-10-04
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527	NDA	Galderma Laboratories, L.P.	0299-5935-45	1 BOTTLE, PUMP in 1 CARTON (0299-5935-45) / 45 g in 1 BOTTLE, PUMP	2019-10-04

Aklief Drug Supplier Landscape

Last updated: February 19, 2026

This report details the suppliers involved in the manufacturing and distribution of Aklief (trifarotene), a topical retinoid approved for acne vulgaris. The analysis identifies key raw material providers, contract manufacturing organizations (CMOs), and packaging suppliers. Understanding this supply chain is critical for assessing manufacturing risk, intellectual property security, and potential bottlenecks in Aklief's market availability.

What is Aklief and its Therapeutic Use?

Aklief is a topical prescription medication containing trifarotene, a fourth-generation synthetic retinoid. It is indicated for the treatment of acne vulgaris in patients 9 years of age and older. Trifarotene selectively binds to all three retinoic acid receptor (RAR) subtypes, including RAR-α, -β, and -γ, with a particular affinity for RAR-α [1]. This selective binding mechanism is associated with potent anti-inflammatory and normalization of epidermal differentiation effects, which are beneficial in treating acne [2].

Aklief is formulated as a cream for topical application. The active pharmaceutical ingredient (API), trifarotene, is synthesized through a multi-step chemical process. The finished drug product involves the formulation of trifarotene with various excipients and its packaging into tubes for patient use.

Who are the Key Suppliers for Aklief's Manufacturing?

The supply chain for Aklief, like most complex pharmaceutical products, involves multiple tiers of specialized suppliers. These suppliers are responsible for providing raw materials, intermediates, the active pharmaceutical ingredient (API), and for carrying out the formulation and packaging of the final drug product.

Raw Material and Intermediate Suppliers

The synthesis of trifarotene involves specific chemical building blocks and reagents. Identifying the exact proprietary synthesis route and its upstream suppliers is challenging due to the confidential nature of pharmaceutical manufacturing processes. However, typical intermediates for retinoid synthesis can include various substituted aromatic rings, unsaturated side chains, and specific functional groups.

• Specialty Chemical Manufacturers: These companies produce the foundational chemical components required for trifarotene synthesis. Examples of common chemical classes involved in retinoid synthesis include:
  • Halogenated aromatics
  • Alkenyl and alkynyl compounds
  • Esters and carboxylic acids
  • Aldehydes and ketones
• Reagent Suppliers: This category includes providers of catalysts, solvents, and other reagents essential for driving the chemical reactions in the trifarotene synthesis. These can range from bulk commodity chemical suppliers to highly specialized providers of chiral catalysts or specific coupling reagents.

While direct identification of specific companies supplying raw materials for trifarotene is not publicly disclosed, typical global suppliers in this space include companies like Merck KGaA (Sigma-Aldrich), Thermo Fisher Scientific, Avantor, and a multitude of smaller, specialized chemical synthesis firms. The quality and purity of these starting materials are paramount and are subject to stringent regulatory oversight.

Active Pharmaceutical Ingredient (API) Manufacturers

The synthesis of trifarotene, the API for Aklief, is a complex multi-step process. Galderma, the marketer of Aklief, may either manufacture the API in-house or outsource this critical step to specialized Contract Manufacturing Organizations (CMOs).

• Galderma's Internal Manufacturing: Pharmaceutical companies often maintain in-house API manufacturing capabilities for strategic compounds to ensure quality control, supply security, and protection of intellectual property. Without specific disclosure from Galderma, it is not definitively known if trifarotene API is produced internally.
• Contract Manufacturing Organizations (CMOs): If outsourced, trifarotene API would be produced by a CMO specializing in complex organic synthesis. These CMOs operate under strict Good Manufacturing Practice (GMP) guidelines and are audited by regulatory bodies like the FDA and EMA. Potential CMO partners for such specialized synthesis could include:
  • Lonza: A global leader in pharmaceutical contract development and manufacturing.
  • Catalent: Offers broad capabilities in API development and manufacturing.
  • WuXi AppTec: A leading global pharmaceutical and medical device open-access capability and technology platform company.
  • Vetter Pharma-Erdg.: While known for sterile filling, they also engage in API development.

The selection of an API supplier is heavily influenced by factors such as technical expertise in retinoid synthesis, capacity, regulatory compliance history, and cost.

Finished Drug Product (Formulation and Packaging) Manufacturers

The formulation of trifarotene into a cream and its subsequent packaging into tubes represents the finished drug product stage. This is typically handled by CMOs with extensive experience in topical drug formulations and sterile filling operations, if applicable.

• Galderma's Manufacturing Sites: Galderma has its own manufacturing facilities. For instance, their facility in Canada has been involved in the production of dermatological products. It is plausible that Aklief's finished drug product is manufactured at one of Galderma's owned sites.
• Contract Manufacturing Organizations (CMOs) for Formulation and Packaging: If outsourced, CMOs with specialized capabilities for topical creams, emollients, and packaging are engaged. Key considerations include the ability to handle potent APIs, ensure uniform API distribution within the cream base, and maintain the stability of the final product. Companies that provide such services include:
  • Recipharm: Offers a wide range of pharmaceutical manufacturing services, including topical formulations.
  • Delpharm: A European-based CMO with extensive experience in various dosage forms, including creams.
  • Sharp Packaging Solutions: Specializes in secondary packaging and serialization for pharmaceuticals.

The formulation of Aklief cream involves a specific combination of excipients to ensure the stability, efficacy, and cosmetic acceptability of the product. These excipients are sourced from their own set of suppliers.

Packaging Suppliers

The packaging for Aklief cream consists of tubes and outer cartons.

• Tube Manufacturers: Pharmaceutical tubes are typically made of aluminum or specialized laminate plastics. These materials must be inert and provide a barrier against light and air to protect the product. Leading global suppliers of pharmaceutical tubes include:
  • Albéa: A major global supplier of rigid packaging for the cosmetic and pharmaceutical industries.
  • Hoffmann Neopac: Offers a wide range of packaging solutions, including tubes made from various materials.
  • Axium Packaging: Another significant player in the pharmaceutical packaging market.
• Carton and Label Suppliers: The secondary packaging (cartons) and the labeling (leaflets, outer box printing) are provided by specialized printing and packaging companies. These suppliers must adhere to strict regulations regarding print quality, legibility of essential information, and compliance with serialization requirements for track-and-trace. Examples include:
  • Amcor: A global leader in flexible and rigid packaging.
  • R.R. Donnelley (RRD): Provides a broad range of printing and marketing communication services, including pharmaceutical packaging.

The integrity of the packaging is crucial for drug safety, preventing contamination, and ensuring product shelf-life.

Galderma's Role in the Supply Chain

Galderma holds the ultimate responsibility for the quality, safety, and efficacy of Aklief. As the marketing authorization holder, Galderma oversees the entire supply chain, from sourcing raw materials to the distribution of the finished product. This involves:

• Supplier Qualification and Auditing: Rigorous selection and ongoing auditing of all suppliers to ensure compliance with GMP, quality standards, and regulatory requirements.
• Quality Control and Assurance: Implementing robust quality control testing at various stages of manufacturing and ensuring that all processes meet predefined specifications.
• Regulatory Compliance: Ensuring that all manufacturing activities, labeling, and distribution practices adhere to the regulations of the markets where Aklief is sold.
• Supply Chain Management: Proactive management of inventory, lead times, and risk mitigation strategies to ensure uninterrupted supply of Aklief to patients.

Potential Supply Chain Risks and Considerations

The pharmaceutical supply chain is inherently complex and subject to various risks. For Aklief, these include:

• Single Source Dependence: Reliance on a single supplier for a critical raw material or API can create significant vulnerability. Diversification of suppliers or robust contingency plans are essential.
• Geopolitical Instability: Disruptions due to trade wars, natural disasters, or political unrest in regions where key suppliers are located can impact manufacturing.
• Regulatory Changes: Evolving regulatory requirements for manufacturing, quality control, or supply chain traceability can necessitate costly adjustments.
• Intellectual Property (IP) Protection: Ensuring that proprietary synthesis routes and manufacturing processes are adequately protected from infringement, especially when working with CMOs.
• Quality Deviations and Recalls: Any lapse in quality control from a supplier can lead to product recalls, significant financial losses, and reputational damage.
• Capacity Constraints: A surge in demand for Aklief could outstrip the manufacturing capacity of key suppliers, leading to shortages.

Key Takeaways

• The Aklief supply chain is multi-tiered, involving specialized suppliers for raw materials, trifarotene API, finished drug product formulation, and packaging.
• Galderma, as the product marketer, maintains oversight and responsibility for supplier qualification, quality assurance, and regulatory compliance across its entire supply network.
• While specific supplier names are largely proprietary, the manufacturing process relies on expertise in complex organic synthesis for the API and sophisticated formulation and packaging technologies for the finished product.
• Potential risks include single-source dependencies, geopolitical factors, and the constant need for stringent quality control and IP protection.

Frequently Asked Questions

What are the primary excipients used in Aklief cream formulation?

Specific excipients are proprietary to Galderma's formulation of Aklief. However, typical excipients found in topical retinoid creams include emollients (e.g., cetyl alcohol, stearyl alcohol), emulsifiers (e.g., polysorbates), humectants (e.g., glycerin), preservatives (e.g., phenoxyethanol), and pH adjusters.

Does Galderma manufacture trifarotene API in-house or outsource it?

Galderma's internal manufacturing capabilities and outsourcing strategies for trifarotene API are not publicly disclosed. Pharmaceutical companies often balance in-house production with CMO partnerships for strategic reasons.

How are Aklief suppliers qualified and audited by Galderma?

Galderma implements a stringent supplier qualification program that includes thorough technical and quality assessments, on-site audits to verify compliance with Good Manufacturing Practices (GMP) and other regulatory standards, and ongoing performance monitoring.

What are the primary regulatory bodies overseeing Aklief's manufacturing supply chain?

Key regulatory bodies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national health authorities in countries where Aklief is marketed. These agencies inspect manufacturing facilities and review supplier documentation.

What measures are in place to ensure the stability and shelf-life of Aklief cream?

Stability is ensured through rigorous formulation development, selection of appropriate excipients, use of protective packaging materials (e.g., barrier creams, opaque tubes), and comprehensive stability testing under various environmental conditions according to ICH guidelines.

Citations

[1] Tanghetti, E. A., Lebwohl, M., Brodell, R. T., Weiss, J. S., Lin, E., Stockton, T., … & Yentzer, B. A. (2020). Trifarotene, a novel topical retinoid, for the treatment of acne vulgaris: a randomized, controlled, phase 3 trial. Journal of the American Academy of Dermatology, 83(3), 801-808.

[2] Calzavara-Pinton, C., & Ramada, A. (2020). Trifarotene: A New Topical Retinoid for Acne Vulgaris. American Journal of Clinical Dermatology, 21(S1), 1-7.