IndiaMart
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BluepillExpress, a globally recognized pharmaceutical manufacturer and exporter, proudly offers comprehensive third-party manufacturing services for Levothyroxine, a critical medication used in the management of hypothyroidism and other thyroid disorders. With an unwavering commitment to quality, compliance, and innovation, BluepillExpress delivers world-class solutions to businesses looking to enhance their product portfolio with reliable and effective thyroid hormone replacements.
Our end-to-end third-party manufacturing services allow clients to leverage our world-class infrastructure, advanced formulation expertise, and regulatory proficiency to bring Levothyroxine formulations to market under their own brand names.
What is Levothyroxine?
Levothyroxine, also known as L-thyroxine, is a synthetic form of the thyroid hormone thyroxine (T4). It is primarily used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone, leading to symptoms such as fatigue, weight gain, and depression. Levothyroxine restores the hormone balance in the body, thereby regulating metabolism and energy levels.
The medication is also prescribed for other conditions, including:
- Goiter (enlarged thyroid)
- Thyroid cancer (as part of suppression therapy)
- Myxedema coma (a severe form of hypothyroidism)
Levothyroxine is typically administered orally in tablet form, with dosage customized according to the patient’s age, weight, and thyroid hormone levels.
Why Partner with BluepillExpress for Levothyroxine Manufacturing?
At BluepillExpress, we combine science, precision, and regulatory excellence to provide unmatched third-party manufacturing solutions. When you partner with us for Levothyroxine manufacturing, you benefit from:
1. Regulatory Compliance & International Standards
Our facilities are WHO-GMP certified and comply with stringent international standards, including:
- US FDA
- EU GMP
- TGA (Australia)
- MHRA (UK)
- ANVISA (Brazil)
We ensure that all Levothyroxine formulations meet global regulatory standards, making them eligible for export and distribution in over 140 countries.
2. Advanced Manufacturing Infrastructure
BluepillExpress operates state-of-the-art manufacturing units equipped with:
- Class 100,000 cleanrooms
- Precision-controlled HVAC systems
- High-speed tablet compression and coating machines
- Automated packaging lines
- Stability chambers for ICH-compliant studies
Our facilities are equipped to handle bulk production of Levothyroxine tablets while maintaining uniformity, purity, and potency.
3. Stringent Quality Assurance
Quality is at the core of everything we do. We employ a rigorous multi-step QA/QC process, including:
- Raw material analysis
- In-process checks
- Finished product testing
- Microbiological testing
- Stability studies
Our in-house laboratories are equipped with HPLC, UV spectrophotometers, dissolution testers, and other high-end analytical instruments to ensure batch-to-batch consistency and compliance.
4. Customized Product Development
We offer customized formulation development for Levothyroxine, including:
- Multiple dosage strengths (e.g., 25 mcg, 50 mcg, 75 mcg, 100 mcg, 125 mcg, 150 mcg, 200 mcg)
- Special tablet coatings (film-coated, enteric-coated)
- Packaging variations (blister packs, bottles)
- Brand-specific labeling and carton design
Our R&D and formulation teams work closely with you to develop Levothyroxine products that meet your target market requirements and brand identity.
5. Cost-Effective and Scalable Solutions
Our efficient processes and bulk procurement strategies allow us to offer highly competitive pricing without compromising on quality. We provide scalable manufacturing services suitable for:
- Startups and new entrants in the pharmaceutical sector
- Established companies expanding their thyroid portfolio
- International importers and distributors
Technical Overview of Levothyroxine Tablets
| Parameter | Details |
|---|---|
| API | Levothyroxine Sodium |
| Dosage Form | Oral Tablet |
| Strengths Available | 25 mcg, 50 mcg, 75 mcg, 100 mcg, 125 mcg, 150 mcg, 200 mcg |
| Tablet Color Options | Color-coded as per strength for safety |
| Packaging | Blister packs, HDPE bottles, Alu-Alu |
| Shelf Life | Typically 24 months |
| Storage Conditions | Store below 25°C in dry conditions |
| Regulatory Support | Dossiers, COA, MOA, MSDS, COPP, FSC |
Packaging & Branding Services
At BluepillExpress, we understand the importance of presentation and branding in the pharmaceutical market. Our packaging services are designed to enhance product appeal while maintaining regulatory compliance.
We offer:
- Private labeling with your brand name and logo
- Customized primary and secondary packaging
- Multilingual labeling for global markets
- Tamper-evident and child-resistant packaging options
Our in-house graphic design team collaborates with your marketing division to create visually appealing, regulation-compliant packaging that stands out in competitive markets.
Therapeutic Applications
Levothyroxine is a life-long therapy for many individuals and remains one of the most prescribed medications worldwide. It is primarily used for:
- Primary Hypothyroidism
Restoration of normal thyroid hormone levels in adults and children. - Secondary (Pituitary) Hypothyroidism
Replacement of deficient thyroid hormone due to pituitary dysfunction. - Thyroid Cancer Therapy
As a suppressive therapy to reduce TSH levels, preventing tumor recurrence. - Congenital Hypothyroidism in Neonates
Essential for cognitive and physical development in newborns. - Goiter Treatment
Used in patients with goiter to reduce gland size or as post-surgical therapy.
Export Expertise: Global Distribution Network
BluepillExpress is proud to serve a wide client base across regions including:
- North America (USA, Canada)
- Europe (Germany, UK, Spain)
- Africa (Nigeria, Kenya, South Africa)
- Asia (Vietnam, Philippines, Malaysia)
- Middle East (UAE, Saudi Arabia)
- Latin America (Peru, Chile, Brazil)
We provide:
- End-to-end export documentation
- Timely dispatch with secure international packaging
- Regulatory assistance for product registration in target countries
Our dedicated export team ensures seamless logistics and regulatory support, making BluepillExpress a trusted partner in global pharmaceutical supply chains.
Regulatory Documentation & Support
We provide comprehensive regulatory documentation for Levothyroxine, including:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Certificate of Pharmaceutical Product (COPP)
- Free Sale Certificate (FSC)
- Stability data (as per ICH guidelines)
- Manufacturing license and WHO-GMP certification
Our regulatory affairs experts can also assist you with:
- CTD/ACTD dossier preparation
- Market authorization filing
- Product registration in target export markets
Sustainability & Compliance
BluepillExpress maintains eco-friendly manufacturing practices, including:
- Wastewater treatment plants (ETP)
- Responsible sourcing of raw materials
- Minimal use of hazardous solvents
- ISO 14001:2015 environmental management compliance
We are committed to sustainability and corporate responsibility across all operations.
Partner with BluepillExpress for Levothyroxine Manufacturing
At BluepillExpress, we don’t just manufacture—we partner, innovate, and deliver. Our expertise in thyroid hormone replacement therapy manufacturing, coupled with a robust supply chain and client-centric approach, makes us your ideal third-party manufacturing partner for Levothyroxine.
Whether you are a pharmaceutical company, distributor, or startup looking to enter the thyroid treatment market, BluepillExpress offers tailored solutions designed to elevate your brand and ensure long-term success.
