Diclofenac

BluepillExpress is a globally recognized pharmaceutical manufacturing and export company specializing in third-party production services. With decades of experience in manufacturing high-quality pharmaceutical formulations, we are proud to extend our services to businesses seeking to outsource the manufacturing of Diclofenac, a widely used nonsteroidal anti-inflammatory drug (NSAID). At BluepillExpress, we combine advanced technology, expert formulation teams, and international quality standards to deliver unmatched contract manufacturing services.

Understanding Diclofenac

Diclofenac is a well-established NSAID used primarily for its potent analgesic, anti-inflammatory, and antipyretic properties. It is commonly prescribed for conditions such as:

• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis
• Gout
• Dysmenorrhea
• Post-operative pain
• Musculoskeletal injuries

Diclofenac works by inhibiting cyclooxygenase (COX) enzymes, thereby reducing the synthesis of prostaglandins responsible for inflammation and pain. It is available in multiple dosage forms, including tablets, capsules, injections, gels, and suppositories.

Why Choose BluepillExpress for Diclofenac Manufacturing?

1. Regulatory-Compliant Manufacturing Facilities

BluepillExpress operates WHO-GMP, ISO-certified, and regulatory-compliant manufacturing units in India. Our facilities meet the standards set by regulatory bodies such as:

• WHO (World Health Organization)
• GMP (Good Manufacturing Practice)
• US FDA
• UK MHRA
• EU GMP
• TGA (Australia)
• PIC/S

This ensures that all Diclofenac formulations produced under our third-party manufacturing program are of the highest pharmaceutical standards, safe for global export and compliant with the specific regulatory requirements of the target markets.

2. Formulation Expertise

Our expert R&D and formulation development teams have extensive experience in developing a variety of Diclofenac dosage forms, including:

• Diclofenac Sodium / Diclofenac Potassium Tablets
• Sustained-release Tablets
• Gel-based Topical Applications
• Diclofenac Injections (IM/IV)
• Diclofenac Suppositories
• Capsules with Modified Release Profiles
• Combination Formulations (e.g., Diclofenac + Paracetamol)

All formulations are tailored based on bioavailability, therapeutic efficacy, and regulatory acceptability.

3. Customized Solutions for Clients

We understand that each client’s need is unique. That’s why our third-party manufacturing services are customizable, with complete flexibility in:

• Branding and private labeling
• Packaging configurations
• Batch sizes (pilot to commercial scale)
• Documentation and dossier support
• Product registration assistance in the importing country

Whether you are a pharmaceutical startup or an established brand, BluepillExpress ensures a collaborative and scalable manufacturing partnership.

4. Global Export Network

BluepillExpress proudly exports Diclofenac formulations to over 140 countries, including:

• Southeast Asia
• Africa
• CIS Countries
• Middle East
• Latin America
• Eastern Europe
• Western Europe

We possess strong logistical capabilities and legal know-how to support export documentation, regulatory submissions, and timely dispatch, ensuring your product reaches its destination seamlessly.

Quality Assurance and Control

At BluepillExpress, quality is our cornerstone. Our Quality Assurance (QA) and Quality Control (QC) departments enforce stringent procedures across the entire production lifecycle:

• Raw Material Testing: All APIs and excipients undergo rigorous testing to ensure compliance with pharmacopeial standards (IP, BP, USP, Ph. Eur.).
• In-Process Quality Checks: Real-time monitoring and adjustments maintain consistency and prevent batch failures.
• Finished Product Analysis: Includes assay, dissolution, content uniformity, stability testing, and microbial limits.
• Stability Studies: Conducted as per ICH guidelines for long-term and accelerated stability.

Each batch of Diclofenac produced is accompanied by a Certificate of Analysis (COA) and Batch Manufacturing Records (BMR).

Available Dosage Forms and Strengths

We offer a wide range of Diclofenac-based products in multiple dosage strengths and formats:

Oral Dosage Forms

• Diclofenac Sodium Tablets: 25 mg, 50 mg, 75 mg, 100 mg
• Diclofenac Potassium Tablets: 50 mg
• Diclofenac SR Tablets: 75 mg, 100 mg
• Diclofenac Capsules: 50 mg, 75 mg (immediate and sustained release)

Parenteral Dosage Forms

• Diclofenac Injection: 25 mg/ml, 75 mg/3ml (IM/IV use)

Topical Applications

• Diclofenac Gel (1%, 2%)
• Transdermal Patches

Rectal Dosage Forms

• Diclofenac Suppositories: 50 mg, 100 mg

Combination Formulations

• Diclofenac + Paracetamol
• Diclofenac + Serratiopeptidase
• Diclofenac + Misoprostol
• Diclofenac + Rabeprazole (Gastro-resistant combination)

All products can be developed with branded or non-branded packaging based on your market strategy.

Packaging & Labeling Capabilities

BluepillExpress offers state-of-the-art packaging facilities to ensure your Diclofenac products are securely and attractively packed. Our packaging capabilities include:

• Blister packs (Alu-Alu, Blister PVC)
• Strip packing
• Bottled packaging (HDPE, glass)
• Carton packaging with inserts
• Multilingual labeling
• Tamper-evident seals

Custom packaging is available in line with regulatory requirements of the importing country.

Third-Party Manufacturing Process with BluepillExpress

Our third-party manufacturing process is streamlined for transparency, speed, and compliance:

Step 1: Product Finalization

• You confirm your requirement for Diclofenac formulation, dosage form, and quantity.

Step 2: Quotation & Documentation

• We provide a detailed quotation and list of required documents (Drug License, GST, Company Profile, etc.)

Step 3: Agreement and Order Placement

• A manufacturing agreement is signed, and artwork/packaging materials are finalized.

Step 4: Production & Quality Control

• Manufacturing begins under strict GMP protocols with full QA/QC oversight.

Step 5: Delivery

• After testing and approval, products are packed and shipped with all necessary documentation.

We also offer Regulatory Dossier Support (CTD/ACTD format) and assistance for international product registration.

Research and Development (R&D)

BluepillExpress invests consistently in R&D to innovate and improve pharmaceutical formulations. Our R&D team works on:

• Enhancing bioavailability of Diclofenac
• Developing once-daily extended-release formulations
• Improving patient compliance through taste-masking and novel delivery formats
• Conducting stability and compatibility studies

Our ability to customize and innovate sets us apart in the third-party manufacturing space.

Certifications and Compliance

Our facilities are certified with:

• WHO-GMP
• ISO 9001:2015
• ISO 22000:2018
• HACCP
• EU-GMP (select sites)
• US FDA (select APIs and intermediates)

We maintain full traceability from raw materials to finished product, ensuring complete transparency and accountability.

Advantages of Partnering with BluepillExpress

• Turnkey manufacturing solutions
• Low MOQ for startups
• High-volume capacity for large orders
• Dedicated account managers for personalized service
• International regulatory support
• On-time delivery commitments
• Post-sales technical and commercial support

Sustainability and Ethical Practices

BluepillExpress is committed to environmental and ethical standards. We use eco-friendly processes, ensure responsible waste disposal, and enforce ethical labor practices. Our goal is to provide effective healthcare solutions without compromising sustainability.

Conclusion

If you are looking for a reliable third-party manufacturer for Diclofenac, BluepillExpress is your ideal partner. With top-notch facilities, international certifications, regulatory expertise, and a client-first approach, we ensure that your Diclofenac product reaches the market efficiently, cost-effectively, and with impeccable quality.