FORMOTEROL FUMARATE; GLYCOPYRROLATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294	NDA	AstraZeneca Pharmaceuticals LP	0310-4600-12	120 AEROSOL, METERED in 1 INHALER (0310-4600-12)	2016-10-03
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

In the pharmaceutical landscape, sourcing high-quality active pharmaceutical ingredients (APIs) like Formoterol Fumarate and Glycopyrrolate is essential for maintaining production integrity, regulatory compliance, and meeting market demand. These two drugs serve critical roles in respiratory and anesthesia management, respectively, and their supply chains involve a complex network of global suppliers. This analysis offers an in-depth review of leading suppliers, manufacturing standards, and strategic considerations for procurement professionals.

Formoterol Fumarate: Overview and Supplier Landscape

Pharmacological Profile and Use Cases

Formoterol Fumarate is a long-acting beta-2 adrenergic agonist indicated primarily for asthma and chronic obstructive pulmonary disease (COPD). Its rapid onset combined with extended duration makes it vital in inhalation therapy formulations (see [1]).

Major Suppliers

SK Biotek
A South Korean manufacturer, SK Biotek is among the prominent suppliers of Formoterol Fumarate API. The company adheres to stringent Good Manufacturing Practices (GMP) and supplies to global pharmaceutical clients, including some leading inhaler producers.
Hetero Labs
Based in India, Hetero Labs is a key API producer with extensive experience in respiratory drug compounds. Their manufacturing facilities are routinely inspected and certified by global regulatory bodies, including the FDA and EMA, ensuring high-quality API production.
Mitsubishi Chemical Corporation
This Japanese firm supplies formoterol fumarate as an intermediate component, often in partnership with other API producers. Their reputation for quality and innovation makes them a preferred supplier for multinational pharmaceutical companies.
Honeywell Fine Chemicals
Honeywell offers custom synthesis of key APIs, including Formoterol Fumarate, leveraging advanced process technologies. Their global logistics network ensures reliable supply chain continuity.

Supply Chain and Regulatory Considerations

Many suppliers maintain certification under ISO 9001, GMP, and other regulatory compliance standards.
Given the active global demand, supply shortages occasionally emerge, especially amid regulatory changes or manufacturing disruptions.
Contract manufacturing organizations (CMOs) often serve as intermediaries to ensure manufacturing scalability and flexibility.

Glycopyrrolate: Overview and Supplier Network

Pharmacological Profile and Use Cases

Glycopyrrolate is an anticholinergic used to reduce secretions preoperatively, manage peptic ulcers, and treat certain gastrointestinal conditions. Its formulation in both injectable and oral forms makes it a versatile pharmaceutical ingredient.

Leading Suppliers

**FAMAR (Famar Healthcare Services)**
A leading global API producer, FAMAR supplies glycopyrrolate to pharmaceutical companies in Europe and North America. Their rigorous quality controls conform to EU GMP standards.
Sandoz (Novartis)
As a division of Novartis, Sandoz manufactures generic APIs, including glycopyrrolate, leveraging extensive R&D and production infrastructure. They serve a broad global customer base.
Hetero Labs
Besides Formoterol, Hetero Labs also produces high-quality Glycopyrrolate APIs, emphasizing high purity levels compliant with international standards.
Jubilant Life Sciences
Based in India, Jubilant is a significant API manufacturer offering glycopyrrolate. Their facilities are compliant with US FDA and Indian GMP guidelines, ensuring product reliability.
Aspen Pharmacare
An established South African API supplier, Aspen provides glycopyrrolate as part of its respiratory and gastrointestinal portfolios, known for scalable manufacturing.

Supply Chain Dynamics

The majority of suppliers maintain strict adherence to GMP and ISO certifications, with quality audits regularly conducted.
Availability can be affected by geopolitical factors, raw material access, and regulatory shifts.
Many suppliers participate in global consortia to secure supply security and streamline distribution channels.

Emerging Trends and Strategic Sourcing Insights

Regulatory Harmonization: Suppliers investing in compliance with multiple regulatory bodies (FDA, EMA, PMDA) facilitate easier market entry and reduce supply chain risks.
Vertical Integration: Larger pharmaceutical manufacturers tend to prefer suppliers with vertical integration capabilities, ensuring better quality control and supply security.
Local Sourcing: Increasing emphasis on regional suppliers aims to mitigate geopolitical risks and logistical delays, especially under global supply chain disruptions trends.
Innovation in API Synthesis: Advancements in green chemistry and continuous manufacturing enhance API quality and reduce environmental impact, influencing supplier selection.

Key Considerations for Procurement Professionals

Quality Assurance: Prioritize suppliers certified under global standards like GMP, ISO 9001, and DEA regulations where applicable.
Capacity & Reliability: Ensure supplier capacity aligns with anticipated demand to prevent shortages, particularly amid pandemic-induced supply chain instability.
Cost & Lead Time: Balance competitive pricing with reliable delivery schedules; consider strategic stockpiling for critical APIs.
Regulatory Track Record: Choose suppliers with proven regulatory compliance and history of successful audits.
Supply Chain Transparency: Engage with suppliers providing detailed traceability for raw materials and manufacturing processes.

Conclusion

The supply of Formoterol Fumarate and Glycopyrrolate hinges on a limited but globally dispersed pool of reputable API manufacturers. Ensuring a resilient supply chain involves evaluating suppliers based on quality standards, manufacturing capacity, regulatory compliance, and geopolitical stability. Collaborating with trustworthy suppliers, fostering multi-source diversification, and aligning procurement strategies with regulatory requirements are vital steps in maintaining a reliable supply chain for these essential pharmaceuticals.

Key Takeaways

Top suppliers for Formoterol Fumarate include SK Biotek, Hetero Labs, Mitsubishi Chemical, and Honeywell.
Leading Glycopyrrolate suppliers are Famar Healthcare, Sandoz, Hetero Labs, Jubilant Life Sciences, and Aspen Pharmacare.
Regulatory compliance (GMP, ISO) and supply capacity are critical criteria for supplier selection.
Geopolitical factors and global disruptions necessitate diversified sourcing strategies.
Ongoing innovation in API manufacturing enhances quality and sustainability, influencing supplier valuation.

Frequently Asked Questions (FAQs)

What are the primary factors to consider when sourcing Formoterol Fumarate API?
Quality standards (GMP compliance), manufacturing capacity, regulatory track record, cost, lead time, and supply chain transparency.
Are there regional restrictions on Glycopyrrolate suppliers?
Certain regions have specific regulatory importing requirements; sourcing from suppliers with certifications recognized internationally (FDA, EMA) mitigates compliance risks.
How can supply chain disruptions for these APIs be minimized?
By diversifying suppliers across regions, establishing long-term contracts, maintaining safety stock, and selecting suppliers with scalable manufacturing capabilities.
What regulatory certifications should suppliers possess?
GMP certification (FDA, EMA, WHO), ISO 9001, and site-specific authorizations ensuring compliance with regional standards.
Is vertical integration important in API supplier evaluation?
Yes, it often correlates with higher control over manufacturing processes, consistency, and supply security, especially for critical APIs like Formoterol Fumarate and Glycopyrrolate.

References

[1] Global Initiative for Asthma. "Global Strategy for Asthma Management and Prevention," 2022.
[2] European Medicines Agency. "Guidelines on the manufacture of inhalation products," 2021.
[3] PharmSource. "API Supply Chain Analysis," 2022.
[4] U.S. Food and Drug Administration. "Guidance for Industry: Quality Systems Approach to Pharmaceutical Quality Regulation," 2020.
[5] Indian Pharmacopoeia Commission. "API Quality Standards," 2021.

Suppliers and packagers for generic pharmaceutical drug: FORMOTEROL FUMARATE; GLYCOPYRROLATE