Suppliers and packagers for INDERAL LA

INDERAL LA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553	NDA	ANI Pharmaceuticals, Inc.	62559-520-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-520-01)	2017-04-28
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553	NDA	ANI Pharmaceuticals, Inc.	62559-520-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-520-30)	2017-04-28
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553	NDA	ANI Pharmaceuticals, Inc.	62559-521-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-521-01)	2017-04-28
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553	NDA	ANI Pharmaceuticals, Inc.	62559-521-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-521-30)	2017-04-28
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553	NDA	ANI Pharmaceuticals, Inc.	62559-522-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-522-01)	2017-04-28
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553	NDA	ANI Pharmaceuticals, Inc.	62559-522-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-522-30)	2017-04-28

Inderal LA Supply Chain Analysis

Last updated: February 19, 2026

This report details the current supplier landscape for Inderal LA, identifying key manufacturers of the active pharmaceutical ingredient (API) and critical excipients. It examines patent protection, market concentration, and potential supply chain vulnerabilities.

What is the Active Pharmaceutical Ingredient for Inderal LA?

The active pharmaceutical ingredient in Inderal LA is propranolol hydrochloride. Propranolol is a non-selective beta-adrenergic receptor antagonist. Its formulation as "LA" indicates a long-acting release mechanism.

Who Manufactures Propranolol Hydrochloride API?

Propranolol hydrochloride API is manufactured by several global pharmaceutical chemical suppliers. Key players include:

• Aurobindo Pharma Ltd.: An Indian multinational pharmaceutical company with significant API manufacturing capabilities.
• Cipla Ltd.: Another major Indian pharmaceutical company with a broad API portfolio.
• Dr. Reddy's Laboratories: A prominent Indian multinational pharmaceutical company involved in API production and generic drug manufacturing.
• Teva Pharmaceutical Industries Ltd.: An Israeli multinational pharmaceutical company that is one of the world's largest manufacturers of generic drugs and APIs.
• Mylan N.V. (now part of Viatris): A global pharmaceutical company with extensive API manufacturing operations.

These companies operate large-scale facilities and supply propranolol hydrochloride to generic drug manufacturers worldwide. Sourcing is often diversified to mitigate risks.

What are the Key Excipients in Inderal LA?

Inderal LA utilizes specific excipients to achieve its sustained-release profile. While the exact proprietary formulation is not publicly disclosed, typical excipients in sustained-release propranolol formulations include:

• Binders: Such as hypromellose (hydroxypropyl methylcellulose or HPMC), which contributes to the matrix structure controlling drug release.
• Lubricants: Such as magnesium stearate, which aids in tablet manufacturing by preventing sticking.
• Fillers/Diluents: Such as microcrystalline cellulose, to provide bulk to the tablet.
• Release Modifiers: Specific polymers or waxes designed to slow the dissolution rate of propranolol hydrochloride over an extended period. Examples can include ethylcellulose or acrylic acid copolymers.

The selection of these excipients is critical for the pharmacokinetic profile of Inderal LA, ensuring consistent drug delivery over a 12- to 24-hour period.

Who Supplies Critical Excipients?

The supply of critical excipients for sustained-release formulations is concentrated among specialized chemical manufacturers.

Hypromellose (HPMC) Suppliers:

HPMC is a widely used polymer in pharmaceutical formulations, particularly for controlled release. Major global suppliers include:

• Dow Chemical Company (now DuPont): A significant producer of HPMC under brand names like Methocel™.
• Ashland Global Holdings Inc.: Offers pharmaceutical-grade cellulosic polymers, including HPMC.
• Shin-Etsu Chemical Co., Ltd.: A Japanese company that manufactures various cellulose derivatives, including HPMC.
• Colorcon Inc.: While primarily known for coatings, Colorcon also provides excipients that can include controlled-release polymers.

The availability and quality of specific HPMC grades are crucial for achieving the desired release profile.

Other Excipient Suppliers:

Suppliers for other common excipients like magnesium stearate and microcrystalline cellulose are numerous and generally less concentrated. However, for specialized release-modifying polymers, the supplier base may be smaller.

• Evonik Industries AG: A German specialty chemicals company that produces a wide range of pharmaceutical excipients, including polymers for controlled release.
• BASF SE: Another major German chemical company with a broad portfolio of pharmaceutical excipients.

It is common for pharmaceutical manufacturers to qualify multiple suppliers for each excipient to ensure supply chain resilience.

What is the Patent Landscape for Inderal LA?

Original patents for Inderal LA (propranolol hydrochloride sustained-release formulation) have long since expired. The core patent for propranolol hydrochloride itself, filed by Imperial Chemical Industries (ICI), expired decades ago.

• Original Composition of Matter Patent (Propranolol Hydrochloride): Expired.
• Original Formulation Patents (e.g., LA formulation): Expired.

Current patent activity related to Inderal LA typically focuses on:

• New manufacturing processes for propranolol hydrochloride or its specific salt forms.
• Novel polymorphic forms of propranolol hydrochloride with improved stability or bioavailability.
• New drug delivery systems or combination products involving propranolol.
• Methods of treatment using propranolol for specific indications.

For generic manufacturers, the absence of active formulation patents allows them to produce bioequivalent versions of Inderal LA once the originator's market exclusivity periods have ended.

What are the Potential Supply Chain Vulnerabilities?

The supply chain for Inderal LA, like many generic pharmaceuticals, faces several potential vulnerabilities:

API Manufacturing Concentration:

While there are multiple API manufacturers for propranolol hydrochloride, a significant portion of global API production for many common drugs is concentrated in India and China. Geopolitical instability, regulatory changes, natural disasters, or localized manufacturing issues in these regions can disrupt supply.

Excipient Dependency:

Specialized excipients, particularly those enabling sustained release, may be sourced from a limited number of manufacturers. A disruption at a primary excipient supplier, such as a fire at a manufacturing plant or raw material shortages, could impact the production of multiple drug products.

Regulatory Scrutiny:

API and excipient manufacturers are subject to stringent regulatory oversight by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Import alerts, warning letters, or facility shutdowns due to Good Manufacturing Practice (GMP) violations can immediately halt the supply of critical components.

Raw Material Sourcing:

The synthesis of propranolol hydrochloride requires various chemical precursors. Disruptions in the supply chain for these upstream raw materials, often originating from diverse global sources, can cascade into API production shortages.

Logistics and Transportation:

Global shipping disruptions, increased freight costs, or port congestion can affect the timely delivery of APIs and excipients to formulation sites.

Quality Control Failures:

Batch failures due to unexpected impurities or deviations from specifications at either the API or excipient level can lead to significant production delays and recalls.

What is the Market Status of Inderal LA?

Inderal LA, originally developed by Wyeth (now part of Pfizer), is a well-established medication for hypertension and other cardiovascular conditions. Its branded market share has diminished significantly due to the availability of generic versions.

• Primary Use Cases: Hypertension, angina pectoris, arrhythmias, migraine prophylaxis, and essential tremor.
• Generic Competition: Numerous pharmaceutical companies market generic versions of propranolol hydrochloride sustained-release tablets.
• Pricing: Generic pricing is highly competitive, driven by the cost of API and excipient sourcing, manufacturing efficiency, and market saturation.
• Market Volume: Despite generic competition, Inderal LA and its generic equivalents remain widely prescribed due to their established efficacy and favorable cost-effectiveness for long-term management of chronic conditions.

The demand for propranolol hydrochloride API and its associated excipients is driven by the sustained global need for generic beta-blocker therapies.

Key Takeaways

• Inderal LA's active pharmaceutical ingredient is propranolol hydrochloride.
• Key API suppliers are primarily based in India and China, including Aurobindo, Cipla, and Dr. Reddy's.
• Critical sustained-release excipients, such as hypromellose, are sourced from specialized chemical manufacturers like Dow (DuPont) and Ashland.
• Original patents for Inderal LA and propranolol hydrochloride have expired; current patent activity focuses on process improvements and new applications.
• Supply chain vulnerabilities include reliance on concentrated API regions, specialized excipient suppliers, regulatory compliance, and upstream raw material sourcing.
• The market for Inderal LA is dominated by generic competition, with sustained demand driven by its therapeutic utility and cost-effectiveness.

Frequently Asked Questions

What is the typical shelf life of Inderal LA tablets?

The typical shelf life for Inderal LA tablets is 24 months from the date of manufacture, provided they are stored under recommended conditions (e.g., at controlled room temperature, protected from light and moisture). Specific product labeling should be consulted for exact expiry dates.

Are there different grades of propranolol hydrochloride API available?

Yes, propranolol hydrochloride API is manufactured to meet pharmacopeial standards, such as those set by the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.). Different grades may exist based on purity profiles, particle size distribution, or specific polymorphic forms, tailored for various formulation requirements.

How does the sustained-release mechanism of Inderal LA work?

Inderal LA utilizes a matrix system, often incorporating polymers like hypromellose. These polymers form a gel layer when exposed to gastric fluid, or create a physical barrier, which slows down the dissolution rate of propranolol hydrochloride. This controlled diffusion and erosion process ensures a gradual release of the drug into the bloodstream over an extended period.

Can the supply of Inderal LA be affected by a single API manufacturer experiencing an issue?

Yes, while multiple API manufacturers exist for propranolol hydrochloride, a significant disruption at a major supplier, especially one with a large market share or a critical role in specific regions, can lead to temporary shortages or price increases for generic formulations. This highlights the importance of qualification of multiple API sources by generic drug producers.

What regulatory hurdles exist for importing propranolol hydrochloride API into the United States?

Importing propranolol hydrochloride API into the United States requires the API manufacturer to be registered with the FDA, and their manufacturing facilities must comply with current Good Manufacturing Practices (cGMP). The product must also meet USP monograph specifications. Importers must file Drug Master Files (DMFs) or reference approved DMFs within their drug product applications. FDA inspections and potential import alerts can significantly impact the ability to import API.

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Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-files/drug-master-files [2] United States Pharmacopeia. (n.d.). USP Drug Standards. Retrieved from https://www.usp.org/products/usp-drug-standards [3] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia (Ph. Eur.). Retrieved from https://www.edqm.eu/en/european-pharmacopoeia-ph-eur-home [4] Pharmaceutical Technology. (n.d.). Excipients for Controlled Release. Retrieved from https://www.pharmaceutical-technology.com/features/excipients-controlled-release/ [5] Various Pharmaceutical Company Websites (e.g., Aurobindo Pharma, Cipla, Dr. Reddy's Laboratories, Teva Pharmaceutical Industries, Ashland Global Holdings, DuPont). (Accessed regularly for current product portfolios and manufacturing capabilities). [6] LexisNexis Patent Analysis. (Proprietary access to global patent databases). (Accessed regularly for patent expiry and new filings related to propranolol hydrochloride and its formulations).