Teneligliptin

Teneligliptin is an advanced oral hypoglycemic agent that belongs to the class of Dipeptidyl Peptidase-4 (DPP-4) inhibitors, widely prescribed in the management of Type 2 Diabetes Mellitus (T2DM). Known for its potent glucose-lowering effect and excellent tolerability, Teneligliptin has become a preferred choice for both monotherapy and combination therapy. It enhances endogenous incretin levels, thereby increasing insulin secretion and decreasing glucagon production in a glucose-dependent manner.

At BluepillExpress, we specialize in the third-party manufacturing of Teneligliptin, offering premium-grade formulations that meet IP/BP/USP quality standards. Our WHO-GMP certified facilities, robust regulatory support, and modern infrastructure ensure cost-effective, reliable, and timely delivery for both domestic and international clients.

What is Teneligliptin?

Teneligliptin is a potent and long-acting DPP-4 inhibitor used to improve glycemic control in adults with type 2 diabetes, particularly when diet and exercise alone are insufficient. It works by prolonging the activity of incretin hormones, thereby promoting insulin secretion and reducing hepatic glucose production.

Therapeutic Class: DPP-4 Inhibitor / Oral Anti-Diabetic
Mechanism of Action: Inhibits DPP-4 enzyme, increases GLP-1 and GIP levels, enhances insulin release, and suppresses glucagon secretion.
Route of Administration: Oral

Therapeutic Indications

Teneligliptin is primarily indicated for the management of Type 2 Diabetes Mellitus in adults.

Clinical Uses:

• Monotherapy in patients inadequately controlled by diet and exercise
• Dual therapy with metformin, sulfonylureas, or glitazones
• Triple therapy with metformin and sulfonylureas or other agents
• Add-on therapy for patients not achieving adequate control with existing anti-diabetic medications
• Ideal for elderly and renal-compromised patients due to low risk of hypoglycemia

Teneligliptin is known for its favorable safety profile, once-daily dosing, and minimal risk of weight gain or hypoglycemia, making it a valuable tool in comprehensive diabetes care.

Why Choose BluepillExpress?

BluepillExpress stands out as a reliable third-party manufacturer of anti-diabetic medications, with world-class production standards, efficient processes, and a global export presence.

Key Advantages:

• WHO-GMP and ISO 9001:2015 certified plants
• Advanced oral solid dosage formulation lines
• Regulatory expertise for semi-regulated and regulated markets
• Customizable packaging and branding
• Private label/OEM services available
• On-time delivery and MOQ flexibility
• Full product dossier support (CTD/ACTD)
• Active exports to 40+ countries across Asia, Africa, CIS, and Latin America

Partnering with us enables clients to focus on market growth while we handle manufacturing excellence.

Available Dosage Forms and Strengths

BluepillExpress offers Teneligliptin in standard and customized strengths, available in tablet form:

• Teneligliptin 20 mg Tablet (standard monotherapy dose)
• Teneligliptin 20 mg + Metformin 500 mg SR Tablet
• Teneligliptin 20 mg + Metformin 1000 mg SR Tablet (available on request)

We also manufacture film-coated and bilayer tablets, with customizable shapes, colors, and embossing to align with your brand identity.

Product Composition

Each formulation is developed using pharmacopeia-grade APIs, excipients, and optimized processes for consistent efficacy and patient safety.

Example Composition – Teneligliptin 20 mg Tablet:

• Active Ingredient: Teneligliptin Hydrobromide Hydrate equivalent to Teneligliptin 20 mg
• Excipients: Lactose monohydrate, microcrystalline cellulose, magnesium stearate, croscarmellose sodium, colloidal silicon dioxide
• Coating (optional): Polyvinyl alcohol, titanium dioxide, polyethylene glycol, colorants

Customization of excipients for gluten-free, sugar-free, or lactose-free formulations is also available based on client requirements.

Manufacturing Process

Our Teneligliptin tablets are produced in state-of-the-art oral solid dosage facilities, using validated and standardized processes in compliance with cGMP.

Manufacturing Workflow:

1. Raw material procurement and verification
2. Granulation (wet/dry based on formulation)
3. Blending with lubricants and disintegrants
4. Tablet compression using rotary presses
5. Optional coating for taste masking and stability
6. Visual inspection and automatic packing
7. Batch-wise quality assurance and release

Every process is documented under Standard Operating Procedures (SOPs) and is traceable under our Batch Manufacturing Records (BMRs).

Quality Control and Assurance

At BluepillExpress, quality assurance is integrated at every stage of production to ensure that each batch meets international regulatory expectations.

QC Parameters Tested:

• Assay and content uniformity
• Disintegration and dissolution profile
• Moisture content
• Hardness and friability
• Impurity profile by HPLC/UV
• Stability testing under ICH conditions
• Microbial limits and tablet integrity

All batches are released only after thorough in-process checks, post-production analysis, and QA clearance.

Packaging and Labeling

We provide complete customized packaging services to match your brand’s visual identity and market requirements.

Packaging Options:

• Blister Packs: PVC/Alu and Alu/Alu 10×10 or 1×10 formats
• HDPE Bottles: 30, 60, or 100 tablets
• Aluminum Pouches for bulk supply
• Mono-cartons and multilingual patient inserts
• Tamper-evident and child-resistant packaging

We offer private label design, foil printing, carton artwork development, and support for serialization/barcoding as per regulatory mandates.

Regulatory and Documentation Support

Our regulatory team provides comprehensive documentation to support product registration and tender submissions in both domestic and international markets.

Available Documentation:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Certificate of Analysis (COA)
• Stability Data (accelerated and real-time)
• CTD/ACTD-format Dossiers
• Product Specifications and MOA
• Safety Data Sheet (SDS)
• Free Sale Certificate (FSC)
• Batch Manufacturing and Packaging Records
• Product Leaflets and Labeling Files

We also offer assistance in country-specific regulatory filings, including those required by GCC, ASEAN, and LATAM health authorities.

Export Capabilities

BluepillExpress has a strong global footprint, exporting Teneligliptin formulations to healthcare distributors, pharmaceutical companies, and institutional buyers worldwide.

Major Export Destinations:

• Africa: Nigeria, Kenya, Tanzania, Ghana, Ethiopia
• Asia-Pacific: Myanmar, Vietnam, Philippines, Sri Lanka, Nepal
• Middle East: UAE, Iraq, Jordan, Yemen
• CIS Nations: Uzbekistan, Kazakhstan, Kyrgyzstan
• LATAM and Caribbean: Bolivia, Dominican Republic, El Salvador
• Island Countries: Maldives, Mauritius, Papua New Guinea

We manage all export logistics, customs documentation, and freight forwarding, ensuring timely and compliant delivery.

Ideal Clients for Teneligliptin Manufacturing

• Pharmaceutical brands and marketing companies
• Government health departments and tenders
• Diabetes care brands and e-pharmacy businesses
• Exporters and pharmaceutical trading houses
• NGOs involved in NCD (Non-Communicable Disease) initiatives
• Hospitals and institutional procurement agencies
• Private label OTC product lines

Why Partner with BluepillExpress?

• WHO-GMP certified facilities and global quality standards
• Cost-effective, scalable third-party production
• Regulatory expertise and documentation support
• Private label development with MOQ flexibility
• Formulation innovation for mono and combination therapies
• On-time production and export with tracking support
• Transparent communication and after-sales assistance