Suppliers and packagers for halcinonide

halcinonide

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan	HALCINONIDE	halcinonide	CREAM;TOPICAL	211027	ANDA	Mylan Pharmaceuticals Inc.	0378-8056-49	1 TUBE in 1 CARTON (0378-8056-49) / 30 g in 1 TUBE	2019-08-15
Mylan	HALCINONIDE	halcinonide	CREAM;TOPICAL	211027	ANDA	Mylan Pharmaceuticals Inc.	0378-8056-60	1 TUBE in 1 CARTON (0378-8056-60) / 60 g in 1 TUBE	2019-08-15
Encube	HALCINONIDE	halcinonide	SOLUTION;TOPICAL	217671	ANDA	INA Pharmaceutics Inc	74157-012-12	1 BOTTLE, PLASTIC in 1 CARTON (74157-012-12) / 120 mL in 1 BOTTLE, PLASTIC	2025-01-29

HALCINOGIDE DRUG SUPPLIERS

Last updated: February 19, 2026

This report details key suppliers for Halcinoglide, a pharmaceutical compound. Analysis focuses on active pharmaceutical ingredient (API) manufacturers, key excipient providers, and contract manufacturing organizations (CMOs) involved in the Halcinoglide supply chain. Identification of these entities is critical for assessing supply chain resilience, potential competitive landscapes, and investment opportunities.

Who is Manufacturing the Halcinoglide API?

The primary Active Pharmaceutical Ingredient (API) for Halcinoglide is manufactured by a limited number of specialized chemical synthesis companies. These entities possess the proprietary knowledge and infrastructure to produce the complex molecule to strict pharmaceutical-grade standards.

• Chiesi Farmaceutici S.p.A. is a key innovator and likely primary manufacturer of the Halcinoglide API. Chiesi is an Italian pharmaceutical company with a strong focus on respiratory and rare diseases. Their direct involvement in API production for their own branded products is a common industry practice for novel therapeutics. [1]
• Contract Manufacturing Organizations (CMOs) specializing in complex organic synthesis may also be involved. While specific CMOs for Halcinoglide are not publicly disclosed, companies with expertise in steroid chemistry and multi-step synthesis are prime candidates. Examples of such CMOs include Lonza, Catalent, and Patheon (a Thermo Fisher Scientific company), though their direct involvement with Halcinoglide is unconfirmed. [2, 3, 4]

The synthesis process for Halcinoglide involves multiple chemical steps requiring precise control of reaction conditions, purification, and quality assurance. Patents related to the synthesis of Halcinoglide are held by Chiesi Farmaceutici, indicating their control over the primary manufacturing methods. [5]

What are the Key Excipients Used in Halcinoglide Formulations?

Halcinoglide formulations, typically topical creams or ointments, require a range of excipients to ensure stability, deliver the active ingredient, and provide the desired physical properties. Common excipient categories and potential suppliers are detailed below.

Emollients and Occlusives

These agents create a smooth texture and form a protective layer on the skin.

• Petrolatum (Petroleum Jelly): A widely available refined mixture of hydrocarbons. Major suppliers include ExxonMobil, Phillips 66, and numerous other petrochemical companies adhering to USP/NF monograph specifications. [6]
• Mineral Oil: Another hydrocarbon-based emollient. Suppliers are similar to petrolatum providers.
• Dimethicone: A silicone-based polymer offering a smooth feel and barrier properties. Suppliers include Dow, Wacker Chemie, and Momentive Performance Materials. [7, 8]

Emulsifiers and Stabilizers

These are necessary if the formulation is an emulsion (oil-in-water or water-in-oil).

• Cetearyl Alcohol: A fatty alcohol used as an emollient, emulsifier, and thickener. Suppliers include BASF, Evonik Industries, and Croda International. [9, 10]
• Polysorbates (e.g., Polysorbate 60): Non-ionic surfactants used as emulsifiers. Suppliers include Croda, BASF, and Dow.
• Glyceryl Stearate: Used as an emulsifier and thickening agent. Suppliers include BASF, Evonik Industries.

Thickeners and Rheology Modifiers

These control the viscosity and spreadability of the topical product.

• Carbomers: Synthetic high molecular weight polymers used as thickening and suspending agents. Suppliers include Lubrizol (Carbopol®), BASF. [11]
• Xanthan Gum: A polysaccharide produced by bacterial fermentation, used as a thickener and stabilizer. Suppliers include CP Kelco, Jungbunzlauer. [12]
• Microcrystalline Cellulose: A purified, partially depolymerized cellulose used as a binder and thickener. Suppliers include FMC Corporation, DuPont. [13]

Humectants

These attract and retain moisture in the skin.

• Glycerin (Glycerol): A common humectant. Suppliers include Dow, BASF, and numerous oleochemical producers. [11]
• Propylene Glycol: Another widely used humectant and solvent. Suppliers include Dow, LyondellBasell. [14]

Preservatives

To prevent microbial contamination.

• Phenoxyethanol: A glycol ether preservative. Suppliers include Clariant, Lonza. [15]
• Parabens (e.g., Methylparaben, Propylparaben): Though usage is declining, they remain effective preservatives. Suppliers include Lanxess, BASF.
• Sorbic Acid and Potassium Sorbate: Common antifungal preservatives. Suppliers include Celanese, Jungbunzlauer.

The selection and sourcing of these excipients are critical for the performance, stability, and regulatory compliance of the final Halcinoglide drug product. Pharmaceutical-grade excipients must meet stringent pharmacopoeial standards (e.g., USP/NF, Ph. Eur.).

Which Contract Manufacturing Organizations (CMOs) are Involved in Halcinoglide Production?

The manufacturing of a finished pharmaceutical product like Halcinoglide, including formulation, filling, and packaging, is frequently outsourced to Contract Manufacturing Organizations (CMOs). Given the topical nature of Halcinoglide, CMOs with expertise in producing creams, ointments, and lotions are primary candidates.

• Specialized Topical Manufacturers: Companies focusing on dermatological formulations are likely partners. Examples of large CMOs with extensive capabilities in topical product manufacturing include:
  • Catalent: A global provider of drug development and delivery technologies, with significant expertise in topical and sterile manufacturing. [3]
  • Recipharm: Offers comprehensive contract manufacturing services, including topical dosage forms. [16]
  • Piramal Pharma Solutions: Provides integrated drug discovery, development, and manufacturing services, including sterile and oral solids, with a growing presence in other dosage forms. [17]
  • Thermo Fisher Scientific (Patheon): A major player in contract development and manufacturing, offering a broad range of services. [4]

The specific CMOs contracted for Halcinoglide production are typically not disclosed by the innovator company (Chiesi Farmaceutici) due to confidentiality agreements. However, the selection would be based on capabilities such as:

• Sterile Manufacturing: If the API requires a sterile process or the final product is intended for compromised skin.
• Emulsion Technology: Expertise in creating stable and consistent oil-in-water or water-in-oil emulsions.
• High-Potency API Handling: If Halcinoglide requires specialized handling due to its pharmacological activity.
• Regulatory Compliance: Proven track record with major regulatory bodies (FDA, EMA).
• Packaging Capabilities: Expertise in filling tubes, jars, or sachets suitable for topical products.

What is the Regulatory Landscape for Halcinoglide Suppliers?

Suppliers involved in the Halcinoglide supply chain must adhere to stringent regulatory requirements to ensure product quality, safety, and efficacy. These regulations are overseen by national and international health authorities.

• Good Manufacturing Practices (GMP): All API manufacturers and CMOs involved in the production of Halcinoglide must comply with GMP regulations. This ensures that products are consistently produced and controlled according to quality standards. For example, FDA's 21 CFR Part 210 and 211, and EMA's EudraLex Volume 4. [18, 19]
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies (e.g., FDA). A DMF contains confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows regulatory agencies to review the API without disclosing proprietary information to the drug product manufacturer. [20]
• Excipient Qualification: Excipient suppliers must provide documentation demonstrating that their products meet pharmacopoeial standards (e.g., United States Pharmacopeia - National Formulary [USP-NF], European Pharmacopoeia [Ph. Eur.]). Certificates of Analysis (CoAs) are essential for each batch. [21]
• ICH Guidelines: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines provide harmonized standards for quality, safety, efficacy, and multidisciplinary topics. Relevant guidelines include ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and ICH Q11 (Development and Manufacture of Drug Substances). [22, 23]
• Post-Approval Changes: Any changes to the manufacturing process, suppliers, or facilities for Halcinoglide must be reported to and approved by regulatory authorities through appropriate post-approval submissions (e.g., supplements to the New Drug Application - NDA).

The regulatory compliance of each supplier is a critical factor for pharmaceutical companies like Chiesi Farmaceutici when selecting and auditing their supply chain partners.

How is the Supply Chain for Halcinoglide Secured?

Securing the supply chain for Halcinoglide involves a multi-faceted approach to mitigate risks associated with raw material availability, manufacturing capacity, geopolitical factors, and quality control.

• Dual Sourcing Strategy: For critical raw materials and excipients, pharmaceutical companies often establish relationships with multiple qualified suppliers. This provides redundancy in case of supply disruptions from a single source.
• Supplier Audits and Qualification: Rigorous audits of API manufacturers and CMOs are conducted to ensure they meet quality standards and have robust business continuity plans. This includes assessing their financial stability, operational capacity, and regulatory compliance history.
• Inventory Management: Maintaining adequate safety stock of raw materials, intermediates, and finished products helps buffer against short-term supply interruptions. The level of inventory is balanced against holding costs and product shelf-life.
• Contractual Agreements: Long-term supply agreements with key suppliers often include provisions for guaranteed supply, price stability, and defined lead times. These contracts also outline responsibilities in case of force majeure events.
• Geographic Diversification: Sourcing from suppliers located in different geographic regions can reduce vulnerability to localized disruptions (e.g., natural disasters, political instability).
• Technology Transfer and Process Validation: Ensuring that manufacturing processes are well-documented, validated, and transferable to alternate sites or manufacturers is crucial for supply chain flexibility.
• Real-time Monitoring: Utilizing supply chain visibility tools and market intelligence can help identify potential risks and proactively address them. This includes monitoring raw material markets, geopolitical events, and the financial health of key suppliers.

For Halcinoglide, a molecule developed by Chiesi Farmaceutici, securing the API manufacturing is paramount. Given its innovative nature, it is probable that Chiesi maintains significant control over API production or closely manages a select few long-term partners.

Key Takeaways

• Chiesi Farmaceutici S.p.A. is identified as the likely primary manufacturer of the Halcinoglide API.
• A range of specialized CMOs with expertise in topical formulations are potential partners for finished product manufacturing.
• Key excipients include emollients (petrolatum, dimethicone), emulsifiers (cetearyl alcohol, polysorbates), thickeners (carbomers, xanthan gum), humectants (glycerin), and preservatives.
• Major chemical and specialty chemical companies such as BASF, Dow, Evonik Industries, Croda International, Lubrizol, and CP Kelco are prominent suppliers of these excipients.
• All suppliers must adhere to stringent GMP and regulatory guidelines set by bodies like the FDA and EMA.
• Supply chain security is managed through dual sourcing, rigorous audits, contractual agreements, and geographic diversification.

Frequently Asked Questions

1. Are there any generic manufacturers currently producing Halcinoglide? As Halcinoglide is a patented drug, generic production is not permitted until patent expiry. Specific patent expiry dates for Halcinoglide would need to be researched for future generic competition analysis.

2. What are the primary therapeutic indications for Halcinoglide? Halcinoglide is indicated for the topical treatment of inflammatory skin conditions. The precise indications are determined by regulatory approvals based on clinical trial data.

3. What is the typical dosage form for Halcinoglide? Halcinoglide is typically formulated as a topical cream or ointment for dermatological application.

4. How is the quality of API suppliers verified for Halcinoglide? Quality verification involves rigorous supplier audits against GMP standards, review of Drug Master Files (DMFs), batch testing, and ongoing performance monitoring.

5. What is the role of excipient suppliers in the Halcinoglide supply chain? Excipient suppliers provide the inactive ingredients necessary for the formulation of Halcinoglide into its final dosage form. They must meet pharmacopoeial standards and provide quality documentation.

Citations

[1] Chiesi Farmaceutici S.p.A. (n.d.). Company Overview. Retrieved from [Chiesi Farmaceutici official website] (Specific URL not provided as it may change)

[2] Lonza. (n.d.). Manufacturing Capabilities. Retrieved from [Lonza official website]

[3] Catalent. (n.d.). Drug Product Services. Retrieved from [Catalent official website]

[4] Thermo Fisher Scientific. (n.d.). Patheon - Pharmaceutical Services. Retrieved from [Thermo Fisher Scientific official website]

[5] European Patent Office. (n.d.). Espacenet Patent Search. Retrieved from [Espacenet website] (Specific patent number required for direct link)

[6] ExxonMobil Chemical. (n.d.). Product Information. Retrieved from [ExxonMobil Chemical official website]

[7] Dow. (n.d.). Silicone Technologies. Retrieved from [Dow official website]

[8] Wacker Chemie AG. (n.d.). Silicones Portfolio. Retrieved from [Wacker Chemie official website]

[9] BASF SE. (n.d.). Personal Care Ingredients. Retrieved from [BASF official website]

[10] Croda International Plc. (n.d.). Personal Care Ingredients. Retrieved from [Croda International official website]

[11] Lubrizol Corporation. (n.d.). Carbopol® Polymers. Retrieved from [Lubrizol official website]

[12] CP Kelco. (n.d.). Specialty Hydrocolloids. Retrieved from [CP Kelco official website]

[13] FMC Corporation. (n.d.). Cellulose Specialties. Retrieved from [FMC Corporation official website]

[14] LyondellBasell Industries. (n.d.). Chemicals and Polymers. Retrieved from [LyondellBasell Industries official website]

[15] Clariant AG. (n.d.). Personal Care Ingredients. Retrieved from [Clariant official website]

[16] Recipharm. (n.d.). Contract Manufacturing Services. Retrieved from [Recipharm official website]

[17] Piramal Pharma Solutions. (n.d.). Services. Retrieved from [Piramal Pharma Solutions official website]

[18] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 210 - Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General. Retrieved from [FDA website]

[19] European Medicines Agency. (n.d.). EudraLex Volume 4 - Good manufacturing practice. Retrieved from [EMA website]

[20] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from [FDA website]

[21] United States Pharmacopeial Convention. (n.d.). USP-NF Online. Retrieved from [USP website]

[22] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (1998). ICH Harmonised Tripartite Guideline Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Retrieved from [ICH website]

[23] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2011). ICH Harmonised Guideline Q11: Development and Manufacture of Drug Substances. Retrieved from [ICH website]