AVALIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758	NDA	Sanofi-Aventis U.S. LLC	0024-5855-30	30 TABLET, FILM COATED in 1 BOTTLE (0024-5855-30)	2013-01-01
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758	NDA	Sanofi-Aventis U.S. LLC	0024-5856-30	30 TABLET, FILM COATED in 1 BOTTLE (0024-5856-30)	2013-01-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

AVALIDE, marketed for hypertension and heart failure management, is a proprietary pharmaceutical formulation combining irbesartan and hydrochlorothiazide. As a combination drug branded primarily by Sanofi, AVALIDE's supply chain involves a complex network of raw material suppliers, contract manufacturing organizations (CMOs), and distribution channels. Ensuring a stable and compliant supply chain is essential for healthcare providers and pharmaceutical companies seeking to maintain consistent patient care and meet regulatory standards. This article examines the primary suppliers involved in the production and distribution of AVALIDE, highlighting key sourcing strategies, regulatory considerations, and market dynamics shaping its supply landscape.

Active Pharmaceutical Ingredient (API) Sourcing

1. Irbesartan Suppliers

Irbesartan, a selective angiotensin II receptor blocker, is critical to AVALIDE's efficacy. Leading API manufacturers supply high-quality irbesartan, which must adhere to stringent regulatory standards such as those set by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Major Suppliers:
- Mitsubishi Tanabe Pharma Corporation: As the original developer of irbesartan, Mitsubishi's manufacturing plants are certified for global supply, providing both the active ingredient and intermediates. Their plant in Japan adheres to Good Manufacturing Practices (GMP) and supplies APIs worldwide.
- Hetero Labs Limited (India): A prominent player in the global API market, Hetero supplies irbesartan intermediates and bulk APIs to numerous pharmaceutical firms. Their facilities in India are often compliant with international certifications such as WHO-GMP and consequently often serve as sourcing points.
- Aurobindo Pharma: Based in India, Aurobindo manufactures irbesartan API, leveraging cost-efficient production while maintaining compliance with global standards, making them a significant supplier for generic formulations.
Regulatory considerations: Suppliers must demonstrate GMP compliance, undergo rigorous audit processes, and provide batch certification for APIs. Regulatory agencies increasingly scrutinize overseas API facilities, imposing strict import controls or bans on raw materials from non-compliant sources.

2. Hydrochlorothiazide Suppliers

Hydrochlorothiazide, a thiazide diuretic, complements irbesartan in AVALIDE's formulation. It is widely produced due to its long-standing use, with suppliers primarily located in India, China, and Europe.

Major Suppliers:
- Zhejiang Haijian Pharmaceutical Co. (China): A leading Chinese API manufacturer with GMP certification, supplying hydrochlorothiazide to global markets.
- Hikma Pharmaceuticals (UK): As a global generics leader, Hikma sources hydrochlorothiazide from multiple certified suppliers to ensure supply continuity.
- Senda Pharmaceutical (India): Known for bulk API manufacturing, Senda supplies hydrochlorothiazide with rigorous quality standards.
Regulatory considerations: Similar to irbesartan, API suppliers must hold GMP certifications, and their facilities are often subject to inspection by the FDA, EMA, or other regulators, especially when APIs are imported into regulated markets like the U.S. or Europe.

Formulation and Finished Dose Manufacturing

1. Contract Manufacturing Organizations (CMOs)

The production of AVALIDE tablets involves multiple CMOs specializing in pharmaceutical formulation, compression, coating, and final packaging.

Notable CMOs:
- Fenner Pharmaceuticals (India): Supplies validated manufacturing processes for fixed-dose combination tablets, adhering to cGMP standards required for the U.S. and European markets.
- Lohmann & Rauscher (Germany): Provides packaging and labeling solutions, ensuring compliance with regulatory labeling requirements.
- Teva Pharmaceutical Industries: Operates numerous manufacturing plants globally capable of producing AVALIDE formulations for various markets under contract.

2. Quality Assurance and Regulatory Compliance

Manufacturers involved in AVALIDE’s formulation chain are required to meet stringent quality specifications, including dissolution profiles, uniformity testing, and stability requirements as designated by regulatory agencies such as the FDA’s Orange Book or the European Pharmacopoeia. Continuous audits, validation, and batch testing are essential to maintain supply integrity.

Distribution Channels and Market Dynamics

1. Distribution Partners

Leading pharmaceutical distributors such as McKesson, Cardinal Health, and Alliance Healthcare distribute AVALIDE to healthcare providers, hospitals, and pharmacies. These distributors rely on robust logistics networks and inventory management systems to ensure medication availability.

2. Market Trends and Supply Chain Challenges

Supply chain resilience for AVALIDE is affected by:

Raw Material Availability: Disruptions due to geopolitical tensions, such as trade restrictions or pandemics, impact API production and availability.
Regulatory Scrutiny: Authorities’ focus on API supplier audits and manufacturing practices influences sourcing decisions and procurement timelines.
Price Fluctuations: Variations in raw material costs, particularly for irbesartan and hydrochlorothiazide, influence procurement strategies for manufacturers and marketers.

Regulatory and Legal Frameworks

Ensuring compliance with international standards is critical:

API Suppliers: Must possess GMP certification recognized by FDA, EMA, or WHO.
Formulation Manufacturers: Require Drug Master Files (DMFs) or Certificates of Suitability (CEPs) to demonstrate product safety and quality.
Pharmacovigilance: Continuous post-market monitoring of AVALIDE ensures standards are maintained, influencing supply chain stability and supplier reputation.

Emerging Trends and Future Outlook

Shift to Alternative Suppliers: Rising regulatory barriers and geopolitical issues are prompting companies to diversify API sourcing to maintain supply continuity.
Local Manufacturing Initiatives: Countries are investing in domestic API production to reduce dependency on overseas suppliers, shielding against global disruptions.
Innovation in Supply Chain Transparency: Blockchain and digital traceability tools enhance supplier verification processes, reducing counterfeit risks.

Key Takeaways

Supply of AVALIDE hinges on a diversified network of reputable API manufacturers, predominantly from India, China, and Japan, with strict compliance to GMP standards.
Contract manufacturing organizations play an integral role in translating raw APIs into finished dosage forms, with quality assurance at the core.
Regulatory frameworks heavily influence supplier qualification, sourcing decisions, and supply chain stability.
geopolitical and market fluctuations necessitate proactive sourcing strategies, including supplier diversification and integration of technological advances for supply chain transparency.
Ensuring regulatory compliance across all nodes—from raw API suppliers to formulators—is fundamental to uninterrupted access to AVALIDE in global markets.

FAQs

1. Who are the primary API suppliers for irbesartan in AVALIDE?
Major suppliers include Mitsubishi Tanabe Pharma Corporation (Japan), Hetero Labs Limited (India), and Aurobindo Pharma (India), all adhering to global GMP standards.

2. What regulatory standards are API suppliers for AVALIDE required to meet?
They must demonstrate compliance with GMP certifications recognized by authorities such as the FDA, EMA, or WHO, including regular audits and batch certification documentation.

3. How do manufacturing disruptions impact AVALIDE supply?
Disruptions in raw material sourcing, geopolitical tensions, or regulatory actions can cause shortages, delays, or price fluctuations, affecting supply stability.

4. Are there efforts to localize AVALIDE production?
Yes, many countries are investing in domestic API manufacturing to reduce reliance on imports, thus strengthening supply resilience.

5. How does supply chain transparency benefit AVALIDE sourcing?
Advanced tracking technologies, such as blockchain, enhance traceability, reduce counterfeit risks, and ensure compliance throughout the supply chain, ultimately safeguarding patient safety and business continuity.

References

FDA Drug Approval and Oversight: U.S. Food and Drug Administration. API Manufacturer Certifications. (https://www.fda.gov)
Pharmacopoeia Standards: European Pharmacopoeia, 10th Edition.
API Suppliers Profiles: IQVIA Market Insights Reports (2022).
Regulatory Guidance for API Sourcing: WHO Good Manufacturing Practices Guide (2019).
Market Dynamics of API Industry: Global Industry Analysts, Inc., "Pharmaceutical APIs Market," 2023.

Suppliers and packagers for AVALIDE

AVALIDE

Suppliers for the Pharmaceutical Drug: AVALIDE