Large Scale Fortune 500 Procurement
High-Performance Liquid Chromatography (HPLC) Purification Services
Precision Peptide Purification
We specialize in the isolation and purification of GLP-1 and GIP receptor agonists. Our Reverse-Phase HPLC (RP-HPLC) platforms are optimized to remove closely related impurities, truncated sequences, and trifluoroacetate (TFA) counter-ions, ensuring a final product that exceeds 99% purity specifications.
Key Service Features:
- Scalable Preparative HPLC: From gram-scale clinical trials to multi-kilogram commercial API manufacturing.
- High-Resolution Fractionation: Advanced column chromatography techniques to achieve maximum yield without compromising molecular integrity.
- Method Development & Validation: Custom analytical method validation according to ICH Q2(R1) guidelines to support your Regulatory Filing (DMF/ASMF).
State-of-the-Art GMP Clean Room Environment
All purification and post-purification processing—including lyophilization (freeze-drying) and primary packaging—take place within our ISO Class 5 (Class 100) clean room suites.
- Environmental Monitoring: Continuous tracking of particulates, pressure, and humidity to mitigate the risk of cross-contamination.
- Sterile API Processing: Specialized protocols for endotoxin control and bioburden reduction, essential for injectable peptide therapeutics.
- Qualified Equipment: Our systems undergo rigorous IQ/OQ/PQ (Installation, Operational, and Performance Qualification) to meet global health authority requirements.
Comprehensive Quality Assurance (QA) & Control
Our Quality Control (QC) laboratory utilizes ultra-high-performance liquid chromatography (UHPLC) and Mass Spectrometry (LC-MS) to verify:
- Peptide Mapping & Identity
- Residual Solvent Analysis (per ICH Q3C)
- Stability Testing under accelerated and long-term conditions.
Why Choose Tirzepatide Pharma?
By integrating high-throughput HPLC purification with a robust GMP quality management system, we reduce lead times and optimize the cost of goods for your Tirzepatide API production. Our technical expertise in peptide chemistry ensures that even the most challenging hydrophobic profiles are managed with precision.
GMP Pharma Grade APi GLP1 Large Scale Production
Click here to download the Zeptide Pharma private label price sheet, which provides industry-leading preparative HPLC drug purification services, specifically engineered for complex synthetic peptides and Large Molecule Active Pharmaceutical Ingredients (APIs). Our facility operates under strict current Good Manufacturing Practice (cGMP) standards to ensure the highest levels of purity, safety, and regulatory compliance for your clinical and commercial pipelines.
Quality Assurance & Compliance: Our commitment to safety is underpinned by rigorous quality control protocols. All products are manufactured in clean room facilities that comply with Good Manufacturing Practices (GMP) and ISO standards.
- Purity Levels: Consistently achieving 99%+ purity through advanced HPLC testing.
- Documentation: Every batch is accompanied by a comprehensive Certificate of Analysis (CoA) and MSDS documentation.
- Regulatory Alignment: Our processes adhere to established international pharmacopeia standards to ensure stability and efficacy.
B2B Service Offerings:
- Bulk Procurement: Scalable supply chains for healthcare networks, licensed pharmacies, and research institutions.
- Cold-Chain Logistics: Specialized temperature-controlled shipping to maintain peptide integrity from our facility to your destination.
- Custom Formulation Support: Technical consultation for partners requiring specific concentrations or delivery formats for clinical applications.
Target Partnerships: We serve licensed pharmaceutical distributors, registered clinical research organizations (CROs), and healthcare providers looking for a transparent, reliable source of metabolic research compounds.
Inquiry Process: Access to our full catalog and wholesale pricing is reserved for verified business entities. Please contact our technical sales team for compliance verification and procurement specifications.
API Regulatory Compliance & Bulk Peptide Sourcing
We provide B2B procurement teams and compounding manufacturers with comprehensive oversight of the evolving pharmaceutical landscape. Our team monitors the shifting regulatory frameworks governing Active Pharmaceutical Ingredients (APIs), including FDA Section 503A bulk drug substance evaluations.
By tracking substances as they transition between FDA Categories 1 and 2, we support your organization’s risk assessment, vendor qualification, and supply continuity planning. We specialize in providing high-purity, human-grade APIs for research and development, ensuring all documentation and availability align with current jurisdictional requirements. As the regulatory status of key peptides evolves, we ensure your laboratory or manufacturing facility is prepared for upcoming market shifts and expanded sourcing opportunities.
Our B2B manufacturing services prioritize transparency and compliance in the complex peptide market. We provide dedicated monitoring of the FDA’s "Bulk Drug Substances Under Evaluation" lists to help partners navigate the transition of molecules through Category 1 and Category 2 designations.
Current Regulatory Tracking: We maintain readiness for the potential reclassification of key molecular compounds from Category 2 (restricted status) back to Category 1 (available for compounding evaluation). Our procurement support covers the 14 high-priority peptides currently under policy review, including:
- Regenerative Sequences: BPC-157, Thymosin Beta-4 (TB-500), GHK-Cu
- Metabolic & Growth Research: Ipamorelin, AOD-9604, CJC-1295, Tesamorelin
- Neuro-Biochemical Compounds: Selank, Semax, Epitalon, DSIP
- Cellular & Hormonal Signaling: MOTS-c, Kisspeptin-10, KPV
Compliance Note: Availability is dependent on current local and federal status. We provide full COAs (Certificates of Analysis) and cGMP documentation to support your vendor qualification and risk-management protocols.
Customized GLP1
Sterile Peptide Vials
Our vial products undergo a meticulous sterilization and filtration process, using a 0.22-micron PES-layered vacuum filter and a 2000ml Foxx Life Sciences Autofil assembly. Each batch ensures your buffer water is filtered into sterile containers, adhering to the highest laboratory standards. Choose products where every detail counts and your peace of mind is guaranteed—start now with our uncompromising filtration solutions.
We Drive Confidence in Every Vial
Behind every Zeptide Pharma product lies more than innovation—it’s relentless commitment. Each formulation goes through meticulous efficacy testing, evaluated with advanced analytics and real-world data, never settling for less than excellence. Multiple verification stages ensure unrivaled purity and reliability. With us, you’re not just choosing a product—you’re selecting unmatched assurance. Start now and experience confidence in every dose, because at Tirzepatide Pharma, your well-being stands at the heart of our science.
Clinical Purity Backed By Proof
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We Offer Oral-Buccal Therapeutic Peptides
Class: Injectable grade sublingual/oralbuccal peptide with 99.9% purity, with comparable bioavailability as injections. Available in tablet, capsule, sublingual lyophilized powder, and liquid formats.
The single biggest barrier to starting or sticking with GLP-1 therapy is the injection itself.
- Advantage: Elimination of Injection Anxiety. Roughly 20–30% of the adult population has a fear of needles (trypanophobia). By converting GLP-1 to an oral form, we open the market to millions of patients who currently refuse treatment due to the delivery method.
- Result: Higher patient compliance and refill rates compared to injectables, leading to more consistent glycemic control over time.
- We incorporate SNAC permeation enhancer into the capsules for superior delivery
- Simplified Storage: While the injectable pens often require refrigeration before their first use, the oral tablets are generally easier to store and transport, making them more convenient for travel or daily commutes.
- Improved Adherence: Because taking a pill is often seen as less intrusive and easier to incorporate into a daily routine than an injection, patients may be more likely to stick to their treatment plan consistently
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Contact Us: cdmo@tirzepatidepharm.com
Products Use
We specialize in the high-quality synthesis of sterile Tirzepatide, a dual GIP and GLP-1 Active Pharmaceutical Ingredient (API) with 99.8% purity in dry and lyophilized powder forms. We do not manufacture retail products. Additionally, we provide advanced peptide purification services, utilizing state-of-the-art chromatography techniques to ensure optimal purity and stability for your custom peptide needs.
Admin offices: 3200 Wilcrest Drive, Houston, TX 77042:
New Clean Room Site 10200 Plano Rd, Dallas, TX USA email:cdmo@tirzepatidepharm.com or call: 469-428-5508 Four Locations Serving Texas: Garland. Houston. Dallas. Plano
Hours
Open today | 09:00 am – 05:00 pm |
