ANTARA (MICRONIZED): Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695	NDA	Lupin Pharmaceuticals, Inc.	27437-109-06	30 CAPSULE in 1 BOTTLE (27437-109-06)	2009-09-25
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695	NDA	Lupin Pharmaceuticals, Inc.	27437-110-06	30 CAPSULE in 1 BOTTLE (27437-110-06)	2009-09-25
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695	NDA AUTHORIZED GENERIC	Lupin Pharmaceuticals, Inc.	68180-130-06	30 CAPSULE in 1 BOTTLE (68180-130-06)	2013-02-22
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695	NDA AUTHORIZED GENERIC	Lupin Pharmaceuticals, Inc.	68180-131-06	30 CAPSULE in 1 BOTTLE (68180-131-06)	2013-02-22
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

Antara (Micronized), a pharmaceutical formulation predominantly composed of phenylephrine, is utilized for symptomatic relief of nasal congestion associated with colds, allergies, and sinusitis. The designation "micronized" refers to its particle size reduction to enhance absorption and efficacy. As a widely used nasal decongestant, the supply chain for Antara (Micronized) involves multiple manufacturer and distributor segments, each influenced by regulatory standards and manufacturing capacity. This report provides an in-depth analysis of current suppliers, sourcing dynamics, and strategic considerations vital to stakeholders in pharmaceutical procurement and supply chain management.

Overview of Antara (Micronized)

Pharmacological Composition
The active ingredient in Antara (Micronized) is phenylephrine hydrochloride, a synthetic sympathomimetic agent stimulating alpha-adrenergic receptors. The micronization process allows for uniform particle size (~10 microns), enhancing nasal mucosa absorption, resulting in rapid onset of action (within 15 minutes).

Regulatory Status
Antara formulations must meet stringent regulatory approvals, such as those from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national bodies. Manufacturing standards adherence, particularly Good Manufacturing Practices (GMP), is mandatory for all suppliers.

Key Suppliers of Phenylephrine (Micronized)

1. Major API Producers

The active pharmaceutical ingredient (API) for Antara (Micronized) predominantly comes from a limited set of global API manufacturers specializing in high-quality phenylephrine hydrochloride, especially in micronized form.

a. Jiangsu Hengrui Medicine Co., Ltd. (China)
Hengrui is among the largest Chinese API producers, supplying phenylephrine with GMP compliance. Although primarily serving domestic markets, their export capabilities are expanding, and they are known for competitive pricing and consistent quality standards.

b. Zhejiang Haichang Pharmaceutical Co., Ltd. (China)
This manufacturer specializes in respiratory APIs, including micronized phenylephrine, with ISO and GMP certifications aligned with international standards. Their capacity to produce high-grade micronized formulations makes them a significant supplier for global markets.

c. LKPC (Lianyungang Kingray Pharmaceutical Co., Ltd., China)
LKPC offers micronized phenylephrine hydrochloride with robust GMP certifications, capable of large-scale production to meet multinational demands.

d. Pfizer Inc. (USA)
While Pfizer’s focus is broader, they produce phenylephrine APIs used in various formulations, adhering to high regulatory standards. Their presence signifies premium supply quality, although at higher costs.

e. Lee Chang Yong Corporation (South Korea)
This firm supplies micronized APIs with a focus on regulatory compliance and high purity, exporting globally, directed towards Asian and global markets.

2. Contract Manufacturing Organizations (CMOs)

CMOs facilitate custom synthesis and micronization processes:

Gland Pharma (India)
Known for API manufacturing with a growing portfolio of respiratory APIs, including phenylephrine, with certifications securing international regulatory approval.
Cipla Limited (India)
Provides phenylephrine APIs, including micronized grades, optimized for inhalation and nasal formulations, complying with global standards.
昆明康药化学有限公司 (Kunming Kangyao Chemistry Co., Ltd., China)
Specializes in micronization services of APIs, including phenylephrine, serving pharmaceutical companies seeking specific formulations.

Manufacturers of Finished Antara (Micronized)

While API manufacturing is critical, the final product formulation and micronization processes often occur at specialized pharmaceutical manufacturing plants.

Major Finished Product Suppliers:

a. Sandoz (Novartis division, Switzerland)
Sandoz markets nasal decongestants globally, including proprietary formulations of phenylephrine in micronized form, leveraging their extensive manufacturing capacity.

b. Glenmark Pharmaceuticals (India)
Produces OTC nasal decongestant sprays and drops incorporating micronized phenylephrine, with strong regulatory standings.

c. Johnson & Johnson (USA)
Offers nasal decongestant formulations with micronized phenylephrine, emphasizing quality and consistency.

d. Local Generic Manufacturers
In emerging markets, local pharmaceutical companies often produce Antara (Micronized) formulations tailored to regional regulatory requirements and demand volumes.

Supply Chain Dynamics and Market Trends

Regulatory Influence: Stringent GMP and regulatory standards (FDA, EMA) impact supplier selection, favoring established manufacturers with proven compliance.
Geographical Concentration: Asian manufacturers dominate API supply, especially China and India, due to cost efficiencies and manufacturing capacity.
Quality Consolidation: Leading multinationals source APIs from trusted suppliers to ensure consistency, especially after increased regulatory scrutiny post-COVID-19.

Strategic Considerations for Procurement

Quality Assurance: Priority must be given to suppliers with certified GMP, ISO certifications, and proven track records.
Cost Optimization: Asian API manufacturers offer competitive rates but require rigorous quality validation.
Supply Security: Establishing multiple supplier relationships can mitigate risk of shortages, especially given geopolitical and supply chain disruptions.
Regulatory Filings: Ensure that suppliers can provide comprehensive documentation compliant with target markets' regulatory frameworks.

Conclusion

The supply of Antara (Micronized), primarily dependent on high-quality phenylephrine hydrochloride APIs, involves a layered network of Chinese, Indian, Korean, and Western manufacturers. Leading API producers such as Zhejiang Haichang, LKPC, and Jiangsu Hengrui dominate the micronized phenylephrine market, supplemented by global pharma giants like Pfizer. Finished formulations are produced by key pharmaceutical players with significant regulatory and quality standards. As demand for nasal decongestants persists, securing reliable sourcing from compliant, quality-certified suppliers remains paramount.

Key Takeaways

Dominant API suppliers include Chinese manufacturers like Zhejiang Haichang and LKPC, with global players such as Pfizer also participating.
Quality certification and regulatory compliance are critical when selecting suppliers for Antara (Micronized) to ensure market access and therapeutic safety.
Asian manufacturers offer cost advantages but should be vetted for GMP compliance and international certifications.
Diversifying supply sources enhances resilience against geopolitical and supply chain disruptions.
Close collaboration with CMOs can optimize formulation flexibility, micronization quality, and production scalability.

FAQs

1. What is the primary active ingredient in Antara (Micronized)?
Phenylephrine hydrochloride is the active ingredient, micronized to improve nasal absorption and effectiveness.

2. Which countries dominate the manufacturing of phenylephrine APIs?
China and India are the leading countries producing phenylephrine APIs, including micronized forms, owing to large-scale manufacturing capacity and cost efficiencies.

3. How can buyers ensure the quality of suppliers for Antara (Micronized)?
By verifying GMP and ISO certifications, reviewing compliance documentation, conducting audits, and assessing past regulatory track records.

4. Are there alternative suppliers to Chinese API manufacturers?
Yes. European and American manufacturers like Pfizer and Novartis produce phenylephrine APIs, often at premium costs but with high regulatory assurance.

5. What trends could impact the supplier landscape for Antara (Micronized)?
Increasing regulatory scrutiny, geopolitical tensions, and supply chain disruptions could shift sourcing strategies toward diversification and local manufacturing.

Sources

[1] FDA Guidance for Industry: API Quality and GMP Standards.
[2] European Medicines Agency, Manufacturing and Import Guidelines.
[3] Market Reports on Respiratory API Production by Chinese and Indian pharmaceutical sectors.
[4] Company disclosures and public filings from Zhejiang Haichang, LKPC, Pfizer, and other relevant manufacturers.

Suppliers and packagers for ANTARA (MICRONIZED)