Suppliers and packagers for PROVENTIL-HFA

PROVENTIL-HFA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-7296-85	1 CANISTER in 1 CARTON (0781-7296-85) / 200 AEROSOL, METERED in 1 CANISTER	2021-03-15
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503	NDA AUTHORIZED GENERIC	Preferred Pharmaceuticals Inc.	68788-7996-2	1 CANISTER in 1 CARTON (68788-7996-2) / 200 AEROSOL, METERED in 1 CANISTER	2021-08-10
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503	NDA AUTHORIZED GENERIC	REMEDYREPACK INC.	70518-4528-0	1 CANISTER in 1 CARTON (70518-4528-0) / 200 AEROSOL, METERED in 1 CANISTER	2025-12-03
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503	NDA AUTHORIZED GENERIC	Proficient Rx LP	82804-036-67	1 CANISTER in 1 CARTON (82804-036-67) / 200 AEROSOL, METERED in 1 CANISTER	2021-03-15

PROVENTIL-HFA Active Pharmaceutical Ingredient (API) Suppliers

Last updated: February 19, 2026

This report details the identified suppliers of Albuterol Sulfate, the active pharmaceutical ingredient (API) in PROVENTIL-HFA. It examines their regulatory status, manufacturing capabilities, and potential impact on the PROVENTIL-HFA supply chain.

What is the Active Pharmaceutical Ingredient in PROVENTIL-HFA?

The active pharmaceutical ingredient (API) in PROVENTIL-HFA is Albuterol Sulfate. Albuterol Sulfate is a bronchodilator used to treat or prevent bronchospasm in people with reversible obstructive airway disease. It is a short-acting beta2-adrenergic agonist [1].

Who Manufactures Albuterol Sulfate API?

Manufacturing of Albuterol Sulfate API is concentrated among a limited number of global suppliers. Key manufacturers include:

• CordenPharma: A full-service contract development and manufacturing organization (CDMO) with facilities in Europe and the United States. CordenPharma has experience in complex API synthesis, including micronization and particle engineering, crucial for inhalation products [2]. Their facility in Caponago, Italy, is a significant site for API production.
• Sun Pharmaceutical Industries Ltd.: A major Indian pharmaceutical company with a broad portfolio of generics and branded products. Sun Pharma manufactures Albuterol Sulfate at its facilities, which are subject to regular inspections by global regulatory bodies [3].
• Granules India Ltd.: Another Indian pharmaceutical company specializing in API and finished dosage form manufacturing. Granules India has a significant presence in the respiratory segment and produces Albuterol Sulfate, often supplying it to global generic manufacturers [4].
• Centrient Pharmaceuticals (formerly Lek Pharmaceuticals d.o.o.): While historically associated with Slovenia, Centrient Pharmaceuticals operates globally. They are known for the production of various APIs, including those for respiratory medications.

The global production landscape for Albuterol Sulfate API is subject to stringent regulatory oversight, primarily from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

What are the Regulatory Considerations for Albuterol Sulfate API?

Regulatory compliance is paramount for API suppliers serving the U.S. market, including those supplying PROVENTIL-HFA. Key considerations include:

• FDA Inspections and Approvals: API manufacturers must undergo regular FDA inspections to ensure compliance with Current Good Manufacturing Practices (cGMP). Site registrations and drug master files (DMFs) are critical. The FDA maintains a database of inspected facilities and their inspection outcomes.
• Drug Master Files (DMFs): API suppliers submit DMFs to regulatory authorities. These confidential documents contain detailed information about the manufacturing process, facilities, and quality control measures for the API. Pharmaceutical companies referencing a DMF in their drug product applications must have a Letter of Authorization from the API supplier [5].
• European Directorate for the Quality of Medicines & HealthCare (EDQM) Certificates: For APIs intended for the European market, a Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) issued by the EDQM is often required. This demonstrates that the API complies with European Pharmacopoeia standards [6].
• ICH Guidelines: Manufacturers are expected to adhere to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, such as ICH Q7 for Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients [7].

Companies relying on these suppliers must ensure their chosen manufacturers maintain an impeccable regulatory record. A history of FDA warning letters, import alerts, or significant cGMP deficiencies can lead to supply disruptions and product recalls.

How Do API Suppliers Impact PROVENTIL-HFA's Supply Chain?

The availability and quality of Albuterol Sulfate API directly influence the production and market availability of PROVENTIL-HFA.

• Geographic Concentration: The manufacturing of Albuterol Sulfate API is largely concentrated in India and Europe. This geographic concentration can create supply chain vulnerabilities due to geopolitical events, trade disputes, or natural disasters.
• Quality and Consistency: Inconsistent API quality can lead to batch failures, requiring extensive investigations and potentially impacting the final drug product's efficacy and safety. Robust quality control processes at the API manufacturing site are essential.
• Lead Times and Capacity: The production lead times for APIs can be substantial, often requiring several months. Manufacturers like CordenPharma, Sun Pharma, and Granules India have dedicated capacity, but sudden demand spikes or production issues at a single facility can strain the supply.
• Cost Pressures: The cost of API is a significant component of the overall drug manufacturing cost. Competition among API suppliers can influence pricing, but market consolidation or significant raw material cost increases can also impact PROVENTIL-HFA's cost structure.
• Regulatory Changes: Evolving regulatory requirements can necessitate significant investment from API manufacturers in terms of process upgrades or quality systems. Suppliers unable to meet these changes may exit the market, impacting the supply base.

For PROVENTIL-HFA, which is a metered-dose inhaler (MDI), the physical characteristics of the Albuterol Sulfate API, such as particle size distribution, are critical for proper device function and drug delivery. Suppliers must consistently produce API meeting these exacting specifications.

What are the Key Specifications for Albuterol Sulfate API?

The specifications for Albuterol Sulfate API are defined by pharmacopoeias and must be met by all reputable suppliers.

• Appearance: White or almost white crystalline powder [8].
• Identification: Must respond to tests for Albuterol Sulfate as described in the relevant pharmacopoeia (e.g., USP, EP) [8].
• Purity: Impurity profiles are critically monitored. Specific limits are set for known impurities, such as related substances and residual solvents. For example, the United States Pharmacopoeia (USP) monograph for Albuterol Sulfate sets limits for specific impurities like 4-Nitroso-2,6-bis(1-methylethyl)phenol [8].
• Assay: The content of Albuterol Sulfate must fall within a defined range, typically 98.0% to 102.0% on the dried basis [8].
• Particle Size Distribution: For inhalation products, particle size is a critical quality attribute. The API must be micronized to achieve a specific aerodynamic particle size distribution (e.g., a mass median aerodynamic diameter (MMAD) suitable for lung deposition). This often involves specialized milling and micronization techniques. While specific MMAD targets are proprietary to the drug product formulation, typical requirements for inhaled APIs are in the range of 1-5 microns [9].
• Water Content: Limits are placed on the amount of water present, typically not exceeding 0.5% [8].
• Residue on Ignition/Sulphated Ash: Limits are set for inorganic impurities, usually not exceeding 0.1% [8].

Suppliers must demonstrate robust control over their manufacturing processes to consistently meet these stringent specifications batch after batch.

How to Assess API Supplier Reliability for PROVENTIL-HFA

Pharmaceutical companies and investors evaluating the PROVENTIL-HFA supply chain should consider the following factors when assessing API suppliers:

• Regulatory Track Record: Review recent FDA inspection reports, warning letters, and import alerts associated with the supplier's facilities. A consistent history of regulatory compliance is essential.
• Quality Management Systems: Assess the supplier's quality management system, including their approach to change control, deviation management, and out-of-specification (OOS) investigations.
• Supply Chain Transparency: Understand the supplier's raw material sourcing and their own supply chain resilience. Are they reliant on single-source raw materials?
• Manufacturing Capacity and Flexibility: Evaluate the supplier's current capacity and their ability to scale up production to meet potential demand increases.
• Technical Expertise: For inhalation products like PROVENTIL-HFA, assess the supplier's expertise in micronization and particle engineering.
• Financial Stability: The financial health of an API supplier is important for long-term supply security.

A thorough due diligence process is required to identify and qualify API suppliers that can reliably meet the quality, regulatory, and volume requirements for PROVENTIL-HFA.

Key Takeaways

• Albuterol Sulfate is the API for PROVENTIL-HFA, with manufacturing concentrated among a few global suppliers including CordenPharma, Sun Pharma, and Granules India.
• Strict regulatory oversight from agencies like the FDA and EMA governs API production, requiring adherence to cGMP and submission of detailed DMFs.
• API supplier reliability is critical for PROVENTIL-HFA's supply chain, impacting product availability, quality, and cost.
• Key specifications for Albuterol Sulfate API include purity, assay, and critically, particle size distribution for effective inhalation.
• Thorough due diligence on API suppliers, focusing on regulatory track record, quality systems, and manufacturing capabilities, is essential for supply chain security.

FAQs

1. Are there any API suppliers for PROVENTIL-HFA that have faced significant regulatory actions recently? Recent FDA inspection data and public records should be reviewed to identify any API manufacturers of Albuterol Sulfate that have received warning letters, import alerts, or have had significant cGMP deficiencies cited that could impact their ability to supply the U.S. market.

2. What is the typical lead time for procuring Albuterol Sulfate API from a qualified supplier? Lead times for API procurement can range from 3 to 12 months, depending on the supplier's existing production schedule, order volume, and any required process validation or qualification steps.

3. How does the particle size of Albuterol Sulfate API affect PROVENTIL-HFA? The particle size distribution of Albuterol Sulfate API is critical for the efficacy of PROVENTIL-HFA. It must be within a precise range (typically 1-5 microns in MMAD) to ensure the drug particles can be effectively inhaled into the lungs and reach the target airways for bronchodilation. Deviations can lead to reduced therapeutic effect or deposition in the upper airways.

4. What are the primary geographic regions where Albuterol Sulfate API is manufactured? The primary manufacturing regions for Albuterol Sulfate API are India and Europe.

5. What is a Drug Master File (DMF) and why is it important for API suppliers? A Drug Master File (DMF) is a submission to the FDA (or other regulatory bodies) that provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. It is important because it allows the API supplier to protect proprietary information while providing the FDA with the necessary data to review the API's quality and safety when referenced in a drug product application.

Citations

[1] National Institutes of Health. (n.d.). Albuterol Sulfate. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a681033.html

[2] CordenPharma. (n.d.). Active Pharmaceutical Ingredients. Retrieved from https://cordenpharma.com/services/api/

[3] Sun Pharmaceutical Industries Ltd. (n.d.). API Manufacturing. Retrieved from https://www.sunpharma.com/manufacturing/api-manufacturing/

[4] Granules India Ltd. (n.d.). Active Pharmaceutical Ingredients. Retrieved from https://www.granulesindia.com/api/

[5] U.S. Food and Drug Administration. (2020, July 29). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-files-dmfs/drug-master-files-dmfs

[6] European Directorate for the Quality of Medicines & HealthCare (EDQM). (n.d.). Certificates of Suitability. Retrieved from https://www.edqm.eu/en/certificates-suitability

[7] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (1999). ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7. Retrieved from https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Step_4_1999.pdf

[8] United States Pharmacopeial Convention. (n.d.). Albuterol Sulfate. In United States Pharmacopeia and National Formulary (USP-NF). (Subscription required; typically accessed via official pharmacopoeia databases).

[9] Clark, A. R., & Gonda, I. (2011). Handbook of Pharmaceutical Particle Design. CRC Press. (General principles of particle size for inhalation).