Montelukast

BluepillExpress is a globally recognized name in the pharmaceutical manufacturing sector, offering top-tier third-party manufacturing services to pharmaceutical companies, healthcare organizations, distributors, and startups worldwide. Specializing in the production of APIs, formulations, and health supplements, BluepillExpress combines cutting-edge infrastructure with unmatched quality assurance standards. One of our flagship offerings is the third-party manufacturing of Montelukast, a critical therapeutic agent widely used in respiratory and allergic conditions.

Montelukast is a leukotriene receptor antagonist (LTRA) frequently prescribed for the treatment and long-term control of asthma, exercise-induced bronchoconstriction, and allergic rhinitis. Its safety, efficacy, and oral administration make it a valuable component of respiratory therapy regimens. As a contract manufacturing partner, BluepillExpress ensures the reliable, compliant, and scalable production of Montelukast, meeting diverse global regulatory standards.

Understanding Montelukast

Pharmacological Classification

• Therapeutic Class: Anti-asthmatic / Anti-allergic
• Pharmacological Class: Leukotriene Receptor Antagonist
• ATC Code: R03DC03

Mechanism of Action

Montelukast functions by selectively antagonizing leukotriene D4 at the cysteinyl leukotriene receptor (CysLT1) in the lungs and bronchial tubes. This action helps prevent airway edema, smooth muscle contraction, and enhanced secretion of mucus, thus alleviating the symptoms of asthma and allergic rhinitis.

Therapeutic Indications

Montelukast is indicated for:

• Prophylaxis and chronic treatment of asthma in adults and pediatric patients.
• Relief of symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).
• Prevention of exercise-induced bronchoconstriction.
• Adjunct therapy in patients with moderate to severe persistent asthma not adequately controlled on inhaled corticosteroids.

Dosage Forms and Strengths Offered by BluepillExpress

BluepillExpress manufactures Montelukast in the following standard formulations and strengths. Customizable options are also available upon client request:

Oral Tablets

• Montelukast 10 mg Tablets – For adult and adolescent patients.
• Montelukast 5 mg Chewable Tablets – For pediatric use (6–14 years).
• Montelukast 4 mg Chewable Tablets – For pediatric use (2–5 years).
• Montelukast 4 mg Granules – For infants and toddlers (6 months–2 years).

All tablets and granules are formulated using GMP-compliant processes to ensure high bioavailability, stability, and patient compliance.

BluepillExpress: A Trusted Third-Party Manufacturing Partner

1. WHO-GMP Certified Infrastructure

BluepillExpress operates state-of-the-art manufacturing units that comply with WHO-GMP, ISO 9001:2015, and other international standards. Our facilities are equipped with dedicated cleanrooms, air handling systems, and validated equipment that ensure contamination-free manufacturing of sensitive respiratory medications like Montelukast.

2. Regulatory Compliances and Certifications

Our plants adhere to stringent regulatory standards including:

• US FDA
• UK MHRA
• EU-GMP
• TGA (Australia)
• PIC/S
• ANVISA (Brazil)

We support clients across multiple regions by offering full documentation, including Certificate of Analysis (CoA), Drug Master File (DMF), and regulatory dossiers as required.

3. Robust Quality Assurance & Quality Control

From sourcing the best-quality Montelukast sodium API to the final formulation, every step is meticulously monitored. Our in-house QA/QC laboratories conduct comprehensive testing including:

• Assay
• Dissolution
• Microbial limits
• Uniformity of dosage units
• Stability testing (ICH guidelines)

We use only validated analytical methods to ensure product safety, efficacy, and compliance.

Custom Manufacturing Capabilities

BluepillExpress provides end-to-end customization options, ensuring our clients receive tailor-made solutions for their specific needs. This includes:

• Branding and Private Labeling
• Custom Packaging Design
• Bottle or Blister Packs
• Multilingual Labeling
• Flexible MOQ (Minimum Order Quantities)

Whether you are launching a new product or expanding your existing Montelukast portfolio, BluepillExpress offers scalable, cost-effective solutions.

Packaging and Labeling Services

We provide a wide range of packaging solutions that ensure product protection, long shelf life, and global transport safety:

• Blister Packs (Alu-Alu / PVC)
• HDPE Bottles
• Sachets and Sachet Boxes
• Secondary Packaging with multilingual printing

All packaging is compliant with international regulations, including FSSAI, FDA, and EMA guidelines.

Global Export and Supply Chain Expertise

BluepillExpress has extensive experience exporting pharmaceutical products to over 35+ countries, including:

• United States
• Canada
• United Kingdom
• UAE
• South Africa
• Nigeria
• Vietnam
• Philippines
• Myanmar
• Latin America

Our well-established supply chain network ensures timely delivery, reduced lead times, and zero compromise on product integrity during transportation.

Why Choose BluepillExpress for Montelukast Manufacturing?

1. Cost Efficiency

Our optimized manufacturing processes, bulk API procurement, and lean operations allow us to offer competitive pricing without compromising quality.

2. Scalability

From pilot batches to full-scale commercial production, BluepillExpress is equipped to handle both small and large volume requirements with ease.

3. Fast Turnaround Time

With a streamlined supply chain and efficient workflow, we ensure rapid order fulfillment and timely delivery, helping you maintain market continuity.

4. Intellectual Property Protection

We honor confidentiality agreements and ensure that all business transactions are handled with utmost professionalism and data security.

5. Technical Support

Our team of pharmacists, chemists, regulatory experts, and formulators work in tandem to help you navigate technical challenges, compliance requirements, and go-to-market strategies.

Product Stability and Shelf Life

All Montelukast formulations manufactured by BluepillExpress undergo rigorous stability studies under ICH guidelines to confirm product longevity and integrity. Our products maintain shelf life of up to 24–36 months, depending on formulation and packaging configuration.

Documentation Support

We provide complete regulatory documentation for Montelukast third-party manufacturing, including:

• Certificate of Analysis (CoA)
• Batch Manufacturing Records (BMR)
• Batch Packaging Records (BPR)
• MSDS (Material Safety Data Sheet)
• GMP and ISO Certifications
• Free Sale Certificate
• Stability Data
• Product Registration Dossiers

Contract Manufacturing Process at BluepillExpress

Step-by-Step Overview

1. Client Consultation & Product Finalization
   Discussion of formulation specifications, target market, packaging needs, and pricing.
2. Quotation & Agreement
   Clear and competitive pricing is offered. Agreement signed with confidentiality and quality clauses.
3. Artwork & Label Approval
   We assist in developing packaging designs in compliance with regional regulations.
4. Production Planning & API Procurement
   GMP-compliant raw material procurement and batch planning.
5. Manufacturing & Quality Control
   Production under strict QA supervision. In-process and post-process quality tests conducted.
6. Packaging & Dispatch
   Custom packaging followed by shipping as per client location and INCOTERMS agreement.

Frequently Asked Questions (FAQs)

Q1: Can BluepillExpress manufacture Montelukast in combination with other drugs?

Yes. We offer fixed-dose combinations such as Montelukast + Levocetirizine and Montelukast + Fexofenadine, customized as per client requirements and regulatory standards.

Q2: What is the minimum order quantity (MOQ) for Montelukast tablets?

Our MOQs are flexible and depend on the formulation type and client needs. We offer low MOQs for startups and bulk manufacturing for large-scale distributors.

Q3: Does BluepillExpress support product registration in other countries?

Yes. Our regulatory team assists with dossier preparation, CTD/eCTD formats, and country-specific product registrations.

Partner with BluepillExpress Today

BluepillExpress continues to redefine excellence in pharmaceutical third-party manufacturing. With a dedicated focus on innovation, compliance, and customer satisfaction, we are your reliable partner for Montelukast and beyond.

Let us help you bring high-quality respiratory care solutions to global markets with efficiency, precision, and trust.