Cabergoline

Cabergoline is a long-acting dopamine receptor agonist primarily used to treat disorders associated with hyperprolactinemia, including pituitary prolactinomas and hormone-related fertility issues. By inhibiting prolactin secretion from the anterior pituitary gland, Cabergoline offers significant therapeutic benefits in treating hormonal imbalances, menstrual irregularities, and infertility in both men and women.

As awareness and diagnosis of endocrine disorders continue to rise worldwide, BluepillExpress offers high-quality, WHO-GMP-compliant third-party manufacturing of Cabergoline, suitable for regulated and semi-regulated markets. Our advanced manufacturing infrastructure and quality-first philosophy ensure consistent production, regulatory compliance, and rapid market scalability for your brand.

What is Cabergoline?

Cabergoline is a dopamine D2 receptor agonist with high affinity and long duration of action. It inhibits prolactin secretion by directly stimulating dopamine receptors on lactotroph cells in the pituitary gland.

Therapeutic Class: Dopamine Agonist
Mechanism of Action: Binds to D2 receptors to suppress prolactin secretion
Route of Administration: Oral (tablets)

Cabergoline is highly preferred over older medications like bromocriptine due to its favorable pharmacokinetics, better tolerability, and once- or twice-weekly dosing.

Therapeutic Indications

Cabergoline is approved and widely used for the treatment of multiple hormonal disorders, especially those linked to elevated prolactin levels.

Approved and Off-label Uses:

• Hyperprolactinemia (elevated prolactin levels)
• Pituitary adenomas (prolactinomas)
• Amenorrhea and galactorrhea
• Infertility due to prolactin excess
• Polycystic ovary syndrome (PCOS)
• Parkinson’s disease (off-label adjunctive use)
• Cushing’s disease (off-label)
• Acromegaly (adjunctive therapy in select cases)

Because of its ability to restore hormonal balance, Cabergoline is a critical endocrine and reproductive health medication.

Why Choose BluepillExpress?

BluepillExpress provides fully integrated third-party manufacturing solutions for specialty APIs like Cabergoline. Our facilities and expertise make us an ideal partner for domestic distributors, export houses, hospitals, and regulatory-driven markets.

Our Advantages:

• WHO-GMP and ISO 9001:2015 certified facilities
• Specialized low-dose API handling systems
• Experienced R&D and formulation development team
• Compliance with IP/BP/USP/EP standards
• Customized packaging, private label, and regulatory support
• Competitive pricing and low minimum order quantities (MOQs)
• Full support for documentation and product registration

We guarantee the quality, safety, and efficacy of all Cabergoline batches manufactured under your brand name.

Dosage Forms and Strengths

We manufacture Cabergoline tablets in standard strengths as per global pharmacopoeial specifications.

Available Strengths:

• Cabergoline Tablets 0.25 mg
• Cabergoline Tablets 0.5 mg

Each tablet is carefully formulated to ensure uniform content, minimal degradation, and long-term stability, considering the potency and sensitivity of the API.

Composition and Ingredients

We use only high-purity, pharmacopeial-grade Cabergoline and inert excipients that enhance stability and bioavailability.

Example: Cabergoline 0.5 mg Tablet

• Active Ingredient: Cabergoline IP/BP/USP – 0.5 mg
• Excipients: Lactose monohydrate, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, and film coating materials

All raw materials are sourced from certified and validated vendors with complete traceability.

Manufacturing Process

Manufacturing Cabergoline requires precision, containment, and low-dose accuracy, which is where BluepillExpress excels.

Key Steps:

1. Material Testing: All raw materials are tested for identity, purity, and microbial safety
2. Granulation: High-shear or direct compression techniques depending on formulation
3. Low-Dose Blending: Accurate dosing achieved via validated low-dosage blending systems
4. Compression: Performed using high-precision tableting machines
5. Film Coating (Optional): Improves stability and swallowability
6. Blister/Bottle Packaging: Done under controlled humidity and temperature
7. Quality Assurance: Every batch passes full-spectrum QC including assay, dissolution, and stability testing

Cabergoline is manufactured in segregated low-dosage areas to ensure cross-contamination control and environmental safety.

Quality Control and Testing

We implement rigorous quality control protocols across all stages of production.

Tests Conducted:

• Assay (Potency)
• Uniformity of content
• Dissolution profile
• Related substances
• Microbial testing (TAMC, TYMC)
• Residual solvents
• Heavy metal analysis
• Accelerated and real-time stability testing

Every batch is released only after receiving a Certificate of Analysis (COA) and passing internal quality audits.

Packaging and Private Label Options

We offer fully customizable packaging solutions that align with your brand’s visual identity and regulatory needs.

Options Include:

• Blister packs (Alu-Alu or PVC-Alu) in 1×4, 1×2, or 1×10 formats
• HDPE bottles for bulk or institutional supply
• Tamper-evident labels, barcoding, serialization (as per local law)
• Multilingual packaging for export destinations
• Private Labeling with custom carton, insert, and branding

Packaging can be adapted to regulatory guidelines in the US, EU, Asia-Pacific, Middle East, Africa, and Latin America.

Regulatory and Technical Documentation

We provide full regulatory and dossier support for Cabergoline product registration in global markets.

Documents Offered:

• Certificate of Pharmaceutical Product (COPP)
• Product Dossier in CTD/ACTD format
• Stability studies (Zone II, III, IV)
• Batch Manufacturing Record (BMR)
• Master Formula Record (MFR)
• Method of Analysis (MOA)
• GMP, ISO, and Free Sale Certificates
• Certificate of Analysis (COA)
• Safety Data Sheets (SDS)

We support submissions to authorities like SFDA (Saudi Arabia), FDA (Philippines), PPB (Kenya), NDA (Uganda), MOH (UAE), INVIMA (Colombia), and others.

Export Capability

BluepillExpress serves as a global export partner for Cabergoline and other specialty APIs. We manage full end-to-end logistics, documentation, and compliance.

Active Export Markets Include:

• Africa: Nigeria, Kenya, Ghana, Ethiopia, Rwanda
• Middle East: UAE, Saudi Arabia, Iraq, Oman
• Asia-Pacific: Vietnam, Philippines, Bangladesh, Sri Lanka
• CIS Countries: Kazakhstan, Uzbekistan, Kyrgyzstan
• Latin America: Bolivia, Dominican Republic, Peru
• Island Nations: Fiji, Papua New Guinea, Maldives

We provide air and sea shipping, customs clearance, cold chain (if required), and multilingual support for all logistics activities.

Target Clients

We serve a diverse clientele that includes:

• Generic pharmaceutical brands
• Endocrinology-focused product lines
• Hormonal therapy providers
• Private-label wellness and fertility brands
• Government and institutional buyers
• Tender-based suppliers and distributors
• Telehealth and online pharmacy platforms

Whether you’re entering a new market or expanding an existing range, BluepillExpress delivers excellence with each batch.

Why Partner with BluepillExpress?

• WHO-GMP certified, ISO 9001:2015 compliant facilities
• Low-dose manufacturing expertise
• Complete confidentiality for private label clients
• Low MOQ and scalable manufacturing
• Full regulatory support
• On-time delivery and consistent supply
• Dedicated support team for project coordination