Spironolactone

Spironolactone is a time-tested potassium-sparing diuretic and aldosterone antagonist used in a variety of clinical settings including congestive heart failure, hypertension, edema, hormonal acne, and polycystic ovary syndrome (PCOS). Due to its dual action as a diuretic and anti-androgen, Spironolactone enjoys widespread demand across multiple therapeutic categories.

As healthcare markets continue to expand globally, the need for high-quality, GMP-compliant Spironolactone formulations is growing. BluepillExpress meets this demand by offering state-of-the-art third-party manufacturing of Spironolactone in multiple strengths and dosage forms. Our WHO-GMP and ISO-certified facilities ensure every product is compliant, export-ready, and meets global safety and efficacy standards.

About Spironolactone

Spironolactone is a synthetic steroidal antimineralocorticoid that competes with aldosterone for receptor sites in the distal renal tubules, promoting sodium and water excretion while conserving potassium. It also has anti-androgenic properties, making it effective in treating hormone-related conditions such as acne, hirsutism, and PCOS.

Therapeutic Class: Potassium-sparing diuretic, Anti-androgen
Mechanism of Action: Aldosterone receptor antagonist; inhibits sodium reabsorption and prevents potassium excretion
Route of Administration: Oral (tablets, capsules)

Clinical Applications and Indications

Spironolactone has wide-ranging applications in cardiovascular, renal, and hormonal disorders, making it a high-demand molecule across both mainstream and specialty markets.

Primary Indications:

• Heart failure (especially NYHA Class III-IV)
• Hypertension (as adjunct therapy)
• Edema associated with liver cirrhosis or nephrotic syndrome
• Primary hyperaldosteronism (Conn’s syndrome)
• Polycystic ovary syndrome (PCOS)
• Acne vulgaris and hormonal acne (off-label use)
• Hirsutism in women
• Hypokalemia prevention (due to other diuretics)

Its unique ability to act on hormonal and cardiovascular pathways makes Spironolactone an important inclusion in essential medicine portfolios worldwide.

Why Choose BluepillExpress?

At BluepillExpress, we specialize in third-party and contract manufacturing services that uphold the highest quality and regulatory standards. Whether you’re launching a new brand or expanding an existing portfolio, we offer cost-effective and efficient solutions for Spironolactone production.

Key Benefits:

• WHO-GMP and ISO-certified facilities
• IP/BP/USP-compliant formulations
• Dedicated hormonal manufacturing lines (segregated units)
• Custom branding, packaging, and private labeling
• Regulatory documentation and export support
• Competitive pricing and flexible MOQs
• On-time delivery and consistent supply chain

We cater to generic brands, specialty pharmaceutical companies, hospitals, tender-based suppliers, and wellness product marketers.

Product Range and Dosage Forms

We manufacture Spironolactone in various strengths and oral dosage forms tailored for adult and specialty therapeutic use.

Available Strengths:

• Spironolactone 25 mg Tablets
• Spironolactone 50 mg Tablets
• Spironolactone 100 mg Tablets

Optional Variants:

• Spironolactone Capsules (on demand)
• Spironolactone Tablets with Hydrochlorothiazide (Fixed-dose combination, on request)

These formulations can be customized for specific market preferences, including scoring, film-coating, and packaging designs.

Composition and Ingredients

Our formulations use pharmaceutical-grade APIs and excipients, ensuring long shelf life, excellent bioavailability, and regulatory compliance.

Example: Spironolactone Tablet 50 mg

• Active Ingredient: Spironolactone IP/BP/USP 50 mg
• Excipients: Lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, sodium starch glycolate, purified talc, and coating polymers

All formulations undergo rigorous taste, stability, and impurity profiling to ensure global acceptance and patient compliance.

Manufacturing Process

Our production process adheres to cGMP standards, ensuring the highest levels of quality, consistency, and safety.

1. Raw Material Testing: Sourcing from validated vendors and full-spectrum testing of APIs and excipients
2. Blending: High-speed blending machines for homogenous mixing
3. Compression: Rotary tablet presses ensure uniform weight, hardness, and disintegration time
4. Coating (if applicable): Film-coating using HPMC or other polymers for better aesthetics and swallowability
5. Packing: Blister or Alu-Alu packs, or bulk supply as per client needs
6. Quality Testing: Assay, dissolution, microbial limits, friability, and uniformity

Dedicated QA/QC teams ensure in-process checks, environmental monitoring, and batch traceability for complete transparency.

Packaging and Customization

BluepillExpress offers customized packaging solutions for Spironolactone tablets, aligning with client branding and regulatory preferences.

Packaging Options:

• Blister packs (10×10, 10x1x10)
• Alu-Alu blister configurations for enhanced moisture protection
• Bottled packaging (plastic/glass) for bulk supply
• Multilingual secondary packaging and barcoding
• Tamper-evident labeling and serialization (as per market needs)

We also support private labeling, allowing businesses to market products under their own brand name with full confidentiality.

Quality Assurance and Stability

Our products undergo a thorough Quality Management System covering all aspects of manufacturing, testing, and release.

Standard Testing Includes:

• API assay and content uniformity
• Dissolution and disintegration
• Microbial testing (TAMC, TYMC)
• Related substances and impurity profiling
• Stability testing (ICH Zone II, III, IV)

Each batch is released only after stringent quality and documentation verification, and is backed by batch-wise Certificates of Analysis (COA).

Regulatory Documentation & Compliance

We provide full regulatory and technical documentation support to facilitate product registration and marketing authorization in international markets.

Available Documentation:

• Certificate of Analysis (COA)
• GMP and ISO Certificates
• Certificate of Pharmaceutical Product (COPP)
• Product Dossier (CTD/ACTD formats)
• Master Formula Record (MFR) and Batch Manufacturing Record (BMR)
• Method of Analysis (MOA)
• Free Sale Certificate, Stability Data

We assist in submissions to health authorities across Africa, Asia, CIS, LATAM, and Middle East, ensuring smooth and quick product registrations.

Export Capabilities

As a globally recognized third-party manufacturer, BluepillExpress supplies Spironolactone to various countries through reliable logistics and export processes.

Countries We Export To:

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

We provide full support with shipping documentation, including commercial invoices, COAs, packing lists, air/sea waybills, and customs clearance.

Ideal Clients for Spironolactone Manufacturing

Our Spironolactone manufacturing services are ideal for:

• Generic pharmaceutical companies
• Private label wellness and hormonal care brands
• Government tenders and institutional suppliers
• Dermatology and gynecology product marketers
• International distributors and export traders
• E-commerce-based nutraceutical and prescription sellers

Whether you’re entering a new market or expanding an existing brand, BluepillExpress helps you succeed with quality and precision.

Why Partner with BluepillExpress?

• WHO-GMP and ISO-Certified manufacturing units
• Scalable production with low MOQs
• Quick turnaround and global delivery logistics
• Confidential white-label manufacturing
• Flexible payment and documentation support
• Compliance with BP, USP, and IP standards
• Highly professional team with global exposure