Carbocisteine

BluepillExpress is a globally trusted name in third-party pharmaceutical manufacturing, providing high-quality medicinal products that meet rigorous international standards. As part of our comprehensive offerings, we specialize in the third-party manufacturing of Carbocisteine, a widely used mucolytic agent that plays a significant role in respiratory health management. Our advanced manufacturing processes, GMP-certified facilities, and regulatory expertise enable us to deliver Carbocisteine in bulk and customized formulations that cater to the unique needs of global clients.

This detailed overview highlights our Carbocisteine manufacturing capabilities, production standards, packaging formats, and why partnering with BluepillExpress ensures excellence, reliability, and compliance at every stage of the supply chain.

About Carbocisteine

Chemical Profile

• Generic Name: Carbocisteine
• IUPAC Name: (R)-2-Amino-3-(carboxymethylsulfanyl)propanoic acid
• Molecular Formula: C5H9NO4S
• Molecular Weight: 179.19 g/mol
• CAS Number: 638-23-3

Carbocisteine is a mucolytic agent that works by breaking down mucus structure, making it easier to expel from the airways. It is often prescribed for chronic obstructive pulmonary disease (COPD), bronchitis, sinusitis, and other respiratory conditions where mucus accumulation hampers normal breathing.

Applications and Benefits

Therapeutic Uses

Carbocisteine is primarily used in the management of:

• Chronic bronchitis
• Chronic obstructive pulmonary disease (COPD)
• Asthmatic bronchitis
• Sinusitis and otitis media
• Cystic fibrosis (as part of supportive care)

Mechanism of Action

Carbocisteine modifies the structure of mucopolysaccharides in mucus by breaking disulfide bonds, reducing mucus viscosity and improving mucociliary clearance. It also exhibits anti-inflammatory properties and enhances the integrity of epithelial tissue in the respiratory tract.

BluepillExpress Manufacturing Capabilities

1. State-of-the-Art Manufacturing Facilities

BluepillExpress operates WHO-GMP, ISO 9001:2015, and EU-GMP certified facilities that adhere to stringent quality controls and process validations. Our Carbocisteine manufacturing units are equipped with:

• Advanced reactor vessels for chemical synthesis
• High-speed granulators for tablet and capsule formation
• Precision liquid filling lines for syrup formulations
• Drying, milling, and blending equipment for powder and sachet production

We support both API and finished formulation production under one roof to streamline quality and delivery timelines.

2. Multiple Dosage Forms Offered

We provide Carbocisteine in a variety of dosage forms, including but not limited to:

• Syrup/Suspension: 250 mg/5 ml, 500 mg/5 ml
• Tablets: 375 mg, 750 mg
• Capsules: Custom strengths
• Powder for Suspension/Sachet: Pediatric and adult formulations
• Bulk API: Available for B2B export and domestic supply

3. Customization Options

Our contract manufacturing solutions allow for:

• Customized strength and formulation development
• Private labeling and branding services
• Packaging in bottles, sachets, blisters, or strips
• Stability testing as per ICH guidelines

We work closely with clients to develop products tailored to regulatory and market-specific demands.

Quality Assurance & Regulatory Compliance

1. Raw Material Sourcing

Carbocisteine API is sourced from validated and audited suppliers, ensuring:

• High purity (≥ 99% assay)
• Absence of contaminants
• Compliance with IP, BP, USP standards

Each batch of raw material is subjected to rigorous incoming quality control protocols.

2. In-Process & Finished Product Testing

Our Quality Control (QC) labs are equipped with:

• HPLC, UV-Vis spectrophotometry, FTIR, and GC systems
• Microbiological testing for sterility and endotoxin levels
• Dissolution, disintegration, and stability tests

All Carbocisteine products undergo:

• Batch-wise testing
• Process validation
• Cleaning validation
• Shelf-life assessment

3. Documentation & Certifications

We provide comprehensive documentation support for domestic and international clients:

• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Batch Manufacturing Record (BMR)
• Stability Data (Accelerated & Long-term)
• Product Dossiers (CTD/eCTD format for regulatory submissions)

Our manufacturing sites are compliant with:

• WHO-GMP
• EU-GMP (on request)
• PIC/S guidelines
• US FDA (for selected lines)

Packaging & Labeling Services

BluepillExpress offers customized packaging solutions to meet global regulatory and market requirements. Packaging options for Carbocisteine include:

Primary Packaging

• HDPE and PET bottles (with child-resistant caps)
• Glass bottles for syrups
• Aluminum/aluminum or blister packs for tablets/capsules
• Sachet pouches (laminated)

Secondary Packaging

• Custom-printed cartons and inserts
• Multilingual labeling
• Barcoding and serialization options
• Tamper-proof seals

We ensure packaging materials are compliant with pharmacopoeial standards (USP, BP, IP) and are suitable for maintaining product stability and safety throughout its shelf life.

Research & Development Support

At BluepillExpress, innovation is at the core of our third-party manufacturing services. We offer robust R&D support to partners who seek to:

• Develop novel fixed-dose combinations with Carbocisteine
• Create pediatric-friendly and sugar-free formulations
• Enhance bioavailability and taste masking
• Comply with evolving international guidelines (e.g., EMA, US FDA)

Our Formulation Development and Analytical Development teams work collaboratively to bring your concept to market faster and more efficiently.

Supply Chain Management and Logistics

We offer end-to-end supply chain services, including:

• API procurement
• Manufacturing and packaging
• Customs clearance support
• Global shipping with cold-chain and ambient logistics
• Inventory and stock management for regular bulk orders

Our global export network spans:

• Southeast Asia
• Africa
• LATAM
• CIS
• Middle East
• EU (upon mutual regulatory alignment)

Why Choose BluepillExpress for Carbocisteine Manufacturing?

1. Proven Expertise

With years of experience in pharmaceutical manufacturing, BluepillExpress is a trusted partner for companies across 40+ countries. Our team of pharmacists, chemists, and regulatory experts ensure unmatched precision in every batch.

2. Competitive Pricing

By streamlining production and minimizing wastage through lean manufacturing practices, we offer cost-effective solutions without compromising quality.

3. Regulatory Intelligence

We stay ahead of the curve in complying with global pharmaceutical regulations, making us a preferred partner for regulated and semi-regulated markets.

4. End-to-End Customization

From formulation to packaging and documentation, we provide flexible, tailored solutions for clients looking to scale quickly and reliably.

5. Confidentiality & Ethics

We follow strict protocols for IP protection, data confidentiality, and client exclusivity to build long-term, transparent partnerships.

Partner with BluepillExpress Today

Whether you’re a pharmaceutical distributor, hospital network, government tender participant, or brand marketer, BluepillExpress is equipped to be your reliable third-party manufacturing partner for Carbocisteine.

We invite you to collaborate with us for:

• Bulk API or finished formulations
• White-label production
• Custom formulation development
• Long-term supply contracts

Contact BluepillExpress today to receive a personalized quotation, technical dossier, and sample evaluation.