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Mometasone / Formoterol bulk supplier for pharma manufacturers

Mometasone / Formoterol Suppliers & Bulk Manufacturers

Available Forms: Inhaler(MDI)

Available Strengths: 100 mcg/5 mcg , 200 mcg/5 mcg

Reference Brands: Dulera®(US)

Category: Respiratory Disorder

Mometasone + Formoterol, sold as Dulera® in the U.S., is a combination inhaler for asthma management. It pairs Mometasone furoate (ICS) with Formoterol fumarate (LABA) to reduce inflammation and improve airflow. Available as a metered-dose inhaler in 100/5 mcg and 200/5 mcg strengths, Dulera® offers effective, long-term asthma control.

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📘 Sourcing Guide

Product Description:

Mometasone + Formoterol, marketed as Dulera® in the United States, is a combination inhaler used to manage asthma in patients aged 12 years and older. It combines Mometasone furoate, an inhaled corticosteroid (ICS) that reduces airway inflammation, with Formoterol fumarate, a long-acting beta-agonist (LABA) that relaxes bronchial muscles for easier breathing. This powerful duo helps control asthma symptoms and prevent attacks. Dulera® is available in metered-dose inhaler (MDI) form in two strengths: 100 mcg/5 mcg and 200 mcg/5 mcg. Widely prescribed in the U.S., it is a key component in respiratory therapy and pharma B2B exports.

Mometasone / Formoterol — third party manufacturing & bulk supply

Mometasone / Formoterol is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Mometasone / Formoterol listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Frequently Asked Questions

Mometasone / Formoterol is used for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). It helps reduce inflammation in the airways and provides long-lasting bronchodilation, improving breathing and preventing asthma symptoms.

This combination is made from mometasone furoate and formoterol fumarate dihydrate. Mometasone is a corticosteroid that reduces airway inflammation, while formoterol is a long-acting beta-2 agonist (LABA) that relaxes airway muscles to improve airflow.

Common trade names include Dulera (USA), Zenhale (Canada), and various regional or generic brands available in global markets.

The original product is marketed by Merck & Co., Inc. (MSD). It is also manufactured by several pharmaceutical companies globally as combination inhalation products.

The complete generic name is mometasone furoate and formoterol fumarate dihydrate.

Brand names include Dulera, Zenhale, and various region-specific generic brands.

This combination is manufactured globally in countries such as the USA, EU nations, Canada, India, and other regions by both innovator and generic pharmaceutical companies.

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