Glibenclamide Sulfonamide Manufacturer in India
High-Purity API Intermediate with Consistent Quality and Scalable Supply.
Glibenclamide Sulfonamide for Pharmaceutical & Industrial Use
Glibenclamide Sulfonamide is a sulfonylurea-based pharmaceutical intermediate crucial to the synthesis of Glibenclamide (Glyburide), a widely prescribed oral antidiabetic agent for type 2 diabetes. As a prominent manufacturer and supplier in India, PYG Lifesciences offers pharma-grade Glibenclamide Sulfonamide with rigorous impurity control, dependable batch-to-batch consistency, and export-compliant documentation. Backed by deep expertise in sulfonamide and sulfonylurea chemistry, PYG delivers on-spec supply for both commercial production and R&D in regulated and semi-regulated markets.
Applications of Glibenclamide Sulfonamide
Glibenclamide Sulfonamide, also known as 5-chloro-N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-2-methoxybenzamide, is integral to the Pharmaceutical industry due to its
reactivity and stable structure. Here’s how it contributes to progress across sectors:
Pharmaceutical Intermediate
- Serves as a critical intermediate in the multi-step synthesis of Glibenclamide (Glyburide), a second-generation sulfonylurea oral antidiabetic drug.
- High assay and controlled impurity levels in this intermediate are essential for ensuring consistent downstream reaction performance, optimal crystallinity of the final API, and regulatory compliance during commercial production.
- Its purity profile directly impacts the yield, particle morphology, and stability of the finished Glibenclamide API, making it indispensable in maintaining therapeutic quality and bioavailability.
Research & Process Development
- Widely adopted in route scouting studies to evaluate synthetic pathways for Glibenclamide and other structurally related sulfonylurea derivatives.
- Supports impurity fate and mapping investigations, enabling chemists to trace degradation or by-product formation throughout the synthesis process.
- Used in crystallization optimization and formulation studies to refine particle size distribution, dissolution profile, and scalability.
- Suitable for scale-up from kilo-lab quantities to pilot and commercial scale, ensuring process reproducibility.
Custom Synthesis Programs (CRAMS/CDMO Integration)
- Can be customized as part of Contract Research and Manufacturing Services (CRAMS) or Contract Development and Manufacturing Organization (CDMO) projects.
- Enables the development of closely related sulfonamide and sulfonylurea building blocks, which are essential for new chemical entity (NCE) development in the antidiabetic category.
- Supports process optimization initiatives, including impurity reduction, solvent substitution, and yield enhancement, tailored to client specifications.
Regulatory & Analytical Use
- Suitable for generating reference standards and conducting method development and validation for Glibenclamide API analysis.
- Used in stability studies to assess intermediate shelf-life under various storage and packaging conditions.
- Plays a role in regulatory submissions by enabling data generation for Drug Master Files (DMFs) or Certificate of Suitability (CEP) dossiers.
Why Choose PYG Lifesciences as Your Glibenclamide Sulfonamide Supplier?
When sourcing a compound as specialized as Glibenclamide Sulfonamide, trust, quality, and capacity matter. The points below set us apart:
Proven Expertise & Experience
Specializes in API intermediates for antidiabetic sulfonylureas. Their operations are grounded in validated procedures, with stringent control systems ensuring repeatable quality and reliability.
State-of-the-Art Manufacturing Facility
Operates in facilities that include glass-lined and stainless steel reactors, controlled exotherm handling, brine chilling, nitrogen blanketing, and closed-transfer systems. In-house analytical labs support rapid in-process control and release testing.
Stringent Quality Control
Implements validated HPLC/GC methodologies to ensure impurity profiling in line with ICH Q3A/B, residual solvent limits per ICH Q3C, and elemental impurity assessments per ICH Q3D. This regulatory rigor assures consistent batch quality and compliance.
Certifications & Compliance
Practices are aligned with ICH Q7 for intermediates. Documentation packs include COA, MSDS/TDS, stability summaries, and declarations regarding origin, BSE-TSE, and GMO-free status. Facilities are audit-ready, both virtually and onsite.
Reliable Supply & Global Reach
PYG ensures supply reliability through structured planning, dual-sourcing of critical raw materials, maintenance of safety stocks, and partnerships with qualified freight forwarders, facilitating on-time delivery across domestic and international markets.
Customer Support & Customisation
Offers tailored technical specifications, precise particle size control, custom packaging formats, and method-bridging support. A dedicated technical team ensures prompt responses and coordination on change control.
Technical Specifications of Our Glibenclamide Sulfonamide
| Specification | Details |
|---|---|
| Chemical Name | Glibenclamide Sulfonamide |
| Synonyms | As used in client-specific synthetic routes |
| CAS Number | 16673-34 |
| Molecular Formula & Weight | Provided on request with CDA/NDA |
| Appearance | Off-white to light beige crystalline powder |
| Assay (HPLC) | NLT 98.0% (typical ≥99.0%) |
| Related Substances (HPLC) | Each ≤0.15%, total ≤0.50% or per customer-approved spec |
| Residual Solvents (GC) | In compliance with ICH Q3C |
| Water (KF) | ≤0.5–1.0% depending on processing and packaging |
| Melting Range | Provided on request |
| Retest Period | Up to 24 months under original sealed conditions (subject to stability data) |
| HS Code | Available upon request |
| Analytical Documentation | Complete IR, ¹H/¹³C NMR, MS, method summaries, impurity rationale, and stability data available under CDA/NDA |
Packaging, Availability & Ordering Information with PYG Lifesciences
We are dedicated to making the procurement process for Glibenclamide Sulfonamide (16673-34) seamless and transparent for our customers.
Here are the essential details regarding packaging, availability, and ordering from PYG Lifesciences, Glibenclamide Sulfonamide suppliers in India:
Packaging Options
Packaging Options
Minimum Order Quantity (MOQ)
Minimum Order Quantity (MOQ)
Production Capacity
Production Capacity
Lead Time & Delivery
Lead Time & Delivery
Shipping & Handling
Shipping & Handling:
Pricing
Pricing
Sample Request
Sample Request
Contact Us to Buy Glibenclamide Sulfonamide
Let’s make your procurement smooth and science-backed. Reach out today:
Get In Touch
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Corporate Office
#610, Nilamber Triumph, Nilamber Circle,
Gotri-Vasna road, Vadodara - 390021 Gujarat
Manufacturing Unit
Plot Nos. C/72, C/73, C/74 GIDC, Saykha Industrial Estate, Taluka: Vagra, District: Bharuch, Gujarat, 392140
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