Suppliers and packagers for NEBIVOLOL HYDROCHLORIDE

NEBIVOLOL HYDROCHLORIDE

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	NEBIVOLOL HYDROCHLORIDE	nebivolol hydrochloride	TABLET;ORAL	203659	ANDA	Golden State Medical Supply, Inc.	51407-483-30	30 TABLET in 1 BOTTLE (51407-483-30)	2015-04-16
Ani Pharms	NEBIVOLOL HYDROCHLORIDE	nebivolol hydrochloride	TABLET;ORAL	203659	ANDA	Golden State Medical Supply, Inc.	51407-484-30	30 TABLET in 1 BOTTLE (51407-484-30)	2015-04-16
Ani Pharms	NEBIVOLOL HYDROCHLORIDE	nebivolol hydrochloride	TABLET;ORAL	203659	ANDA	Golden State Medical Supply, Inc.	51407-484-90	90 TABLET in 1 BOTTLE (51407-484-90)	2015-04-16

Last updated: July 27, 2025

ppliers for the Pharmaceutical Drug: Nebivolol Hydrochloride

Introduction

Nebivolol Hydrochloride, a selective beta-1 adrenergic blocker with vasodilatory properties, is widely prescribed for hypertension and heart failure management. As demand for this medication increases globally, the supply chain dynamic and sourcing strategies have garnered significant attention from pharmaceutical companies, healthcare providers, and industry analysts. This article explores the principal suppliers, sourcing mechanisms, and market trends associated with Nebivolol Hydrochloride, providing critical insights for stakeholders involved in manufacturing, procurement, and distribution.

Overview of Nebivolol Hydrochloride

Nebivolol Hydrochloride’s pharmacological profile includes high selectivity for beta-1 adrenergic receptors, reducing cardiac output and lowering blood pressure (BP). Its unique vasodilatory mechanism involves nitric oxide release, enhancing endothelial function. Since its approval in various countries, including the EU and the US, the market has experienced a diversification of suppliers, particularly as generic production has intensified post-patent expiry.

Major Suppliers of Nebivolol Hydrochloride

1. Major Pharmaceutical Ingredient (API) Manufacturers

The core suppliers of Nebivolol Hydrochloride are pharmaceutical companies specializing in Active Pharmaceutical Ingredients (API). Major players include:

• Hetero Drugs Ltd.
  An India-based API manufacturer, Hetero Drugs is among the earliest to commercialize Nebivolol Hydrochloride at large scales. They have extended their API portfolio with high-quality Nebivolol production, catering to both domestic and international markets. Their manufacturing facilities are certified under GMP standards, ensuring compliance with global quality benchmarks.

• Jubilant Life Sciences
  Also based in India, Jubilant is a prominent API producer with diversified drug portfolios. Their facilities adhere to stringent quality controls, and they supply Nebivolol Hydrochloride to pharmaceutical firms globally, emphasizing cost efficiency and supply reliability.

• Sami Labs
  Sami Labs offers specialty chemicals and APIs, including Nebivolol Hydrochloride. Their focus is on innovative synthesis methods that improve yield and purity, making them a notable supplier in the Asian API manufacturing space.

• Macleods Pharmaceuticals
  While better known for finished dosage forms, Macleods also manufactures APIs, including Nebivolol Hydrochloride, with strategic API production sites in India providing cost advantages for global distribution.

2. Contract Manufacturing Organizations (CMOs)

The complexity of API manufacturing and regulatory compliance has led numerous pharmaceutical companies to outsource production to specialized CMOs, such as:

• Aenova Group
  A German CMO providing manufacturing services for APIs, including Nebivolol Hydrochloride, ensuring high standards of quality and regulatory adherence for branded and generic drug producers.

• Benchchem
  An MSME based in India that provides contract API synthesis for Nebivolol Hydrochloride for clients worldwide, offering flexible production scales and competitive pricing.

Global Market Trends in Nebivolol Hydrochloride Supply

Expansion of Generic Manufacturing

Post-patent expiry (US patent expired in 2019), numerous entrants have entered the market, increasing the number of licensed suppliers. This proliferation stabilizes supply chains and reduces costs but also intensifies competitive pressures.

Shifts Toward Asian Suppliers

India and China dominate API manufacturing, owing to lower production costs and substantial investments in quality infrastructure. India’s regulatory environment, with certifications like WHO-GMP, further boosts confidence in Asian suppliers for global markets.

Supply Chain Challenges and Disruptions

Global supply challenges, including raw material shortages, geopolitical tensions, and COVID-19 pandemic impacts, have temporarily strained Nebivolol Hydrochloride supplies. Companies have responded by diversifying supplier bases and creating buffer inventories.

Regulatory and Quality Considerations

Suppliers must comply with international standards like U.S. FDA, EMA, and WHO-GMP. Certification and audit readiness of manufacturers are critical for procurement legitimacy. Quality assurance processes involve rigorous testing for potency, purity, residual solvents, and heavy metals.

Emerging Supplier Developments

New entrants, particularly from Southeast Asia and Eastern Europe, are increasingly investing in API production capacities for Nebivolol Hydrochloride, driven by rising demand and governmental support for pharmaceutical manufacturing. These developments aim to mitigate geopolitical risks and supply dependencies.

Supply Chain Outlook and Strategic Recommendations

• Diversify Supplier Base:
  Relying on multiple regional suppliers reduces risk and ensures continued access amidst regulatory or logistical disruptions.

• Engage with Certified Manufacturers:
  Prioritize suppliers with WHO-GMP, FDA, or EMA certifications to ensure QC standards and regulatory acceptance.

• Monitor Global Market Trends:
  Stay updated on geopolitical developments, raw material availability, and technological advancements impacting API production.

• Establish Strategic Stockpiles:
  Maintain buffer stocks to offset short-term supply fluctuations, especially amid uncertain geopolitical or pandemic-related disruptions.

Key Takeaways

• The primary suppliers for Nebivolol Hydrochloride are predominantly Indian API manufacturers such as Hetero Drugs, Jubilant Life Sciences, Sami Labs, and Macleods Pharmaceuticals.
• Contract manufacturing organizations (CMOs) play a critical role in ensuring supply continuity for global pharmaceutical companies.
• The post-patent landscape has led to increased generic manufacturing, especially from Asian suppliers, fostering competitive pricing but necessitating rigorous quality oversight.
• Supply chain resilience depends on diversification, certification verification, and strategic planning amid geopolitical and logistical challenges.
• Continuous market monitoring and supplier qualification are vital for ensuring consistent, regulatory-compliant supply of Nebivolol Hydrochloride.

FAQs

1. Who are the leading global suppliers of Nebivolol Hydrochloride?
Indian pharmaceutical companies like Hetero Drugs, Jubilant Life Sciences, Sami Labs, and Macleods Pharmaceuticals are among the primary API suppliers globally, supported by regional CMOs and emerging Asian manufacturers.

2. What quality standards should suppliers meet for Nebivolol Hydrochloride?
Suppliers must comply with WHO-GMP, FDA, or EMA regulations, ensuring high purity, potency, and compliance with pharmacopeial standards (USP, BP).

3. How has the post-patent era affected Nebivolol Hydrochloride supply?
It has increased the number of generic manufacturers, resulting in a broader supplier base, cost reduction, and supply stability, although quality oversight remains essential.

4. What geopolitical factors influence the supply chain for Nebivolol Hydrochloride?
Trade tensions, export restrictions, and regional policy changes in India, China, and other producing countries might impact raw material availability and manufacturing continuity.

5. How can companies safeguard against supply disruptions for Nebivolol Hydrochloride?
By diversifying suppliers, vetting for regulatory compliance, maintaining safety stocks, and establishing long-term contracts with trusted manufacturers.

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Sources:
[1] U.S. Food and Drug Administration (FDA) approvals and patent expiry information.
[2] Industry reports on API manufacturing in India and China.
[3] Company websites and GMP certificates.
[4] Market analyses of beta-blocker APIs and global supply dynamics.