503B/506E Clinical Lab Facility
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Large Scale Fortune 500 Procurement
High-Performance Liquid Chromatography (HPLC) Purification Services
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Partner with a premier GMP Certified outsourcing facility for high-purity peptides. We provide cGMP-compliant sterile peptidesto ensure the highest safety and quality for your clinic’s needs. View our peptide catalog today!
Streamline your business with bulk peptides from a trusted cGMP manufacturer. We specialize in Pharma-grade and RUO Peptides, offering reliable supply chains and rigorous third-party testing for nationwide distribution.
Looking for pharmaceutical-grade peptides? Our sterile injectable manufacturing facility follows strict cGMP guidelines to deliver high-potency, verified peptides for medical and research applications. Request a quote for bulk orders.
Access high-demand wellness peptides from a leading sterile peptide manufacturer. We provide office-stock medications including GLP-1s and more, produced in our state-of-the-art FDA-inspected facility.
Discover the premier manufacturer of sterile glaucoma treatments. We supply high-quality ophthalmic solutions and eye drops for IOP management
The Premier Manufacturer of Sterile Glaucoma Treatments
Welcome to Zeptide Pharma, the industry-leading manufacturer dedicated exclusively to developing and producing sterile glaucoma treatments. We specialize in formulating high-quality, reliable, and accessible ophthalmic solutions designed to effectively manage intraocular pressure (IOP) and preserve vision for patients worldwide.
As a trusted partner for healthcare providers, pharmacies, and pharmaceutical wholesalers, Zeptide Pharma sets the gold standard in sterile ophthalmic manufacturing.
Our Comprehensive Glaucoma Portfolio
At Zeptide Pharma, we understand that every patient's needs are unique. That is why our state-of-the-art sterile manufacturing facilities produce a comprehensive pipeline of advanced glaucoma eye drops and therapies across all major drug classes:
- Prostaglandin Analogs: Industry-leading formulations designed for maximum efficacy in increasing the outflow of aqueous humor.
- Beta Blockers: Highly purified solutions to effectively reduce the production of eye fluid.
- Alpha Agonists & Carbonic Anhydrase Inhibitors: Precision-manufactured sterile drops for dual-action IOP management.
- Rho Kinase Inhibitors: Advanced, next-generation therapies formulated under rigorous sterile conditions.
- Combination Eye Drops: Convenient, multi-action sterile solutions designed to improve patient compliance and therapeutic outcomes.
API Regulatory Compliance & Bulk Peptide Sourcing
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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.
What We Do
Industrial Contract Manufacturing Services
We are a premier industrial contract manufacturing partner dedicated to serving Fortune 500 healthcare organizations and medical enterprises. Specializing in the high-volume production of prescription medications and medical device-drug combination products, we provide end-to-end manufacturing solutions designed for large-scale global distribution.
Our facility bridges the gap between complex pharmaceutical industrial-scale production, ensuring that our partners receive the highest standards of quality, compliance, and supply chain reliability.
Core Services
- Prescription Medicine Contract Manufacturing We offer comprehensive contract manufacturing organization (CMO) services for a wide range of prescription therapeutics. From active pharmaceutical ingredient (API) sourcing and formulation to bulk final packaging, our scalable processes are engineered to meet the stringent demands of top-tier pharmaceutical brands.
- Medical Device Medicines & Combination Products Our specialized capabilities extend to the formulation and filling of medical device-drug combination products. We provide precision and integration for pre-filled syringes, inhalers, transdermal patches, and implantable delivery systems, adhering to strict regulatory standards for both devices and pharmaceuticals.
- Large-Scale Industrial Services: Equipped with state-of-the-art, high-capacity suites, we translate custom or complex formulations into mass-market realities. Our industrial compounding services ensure absolute batch-to-batch consistency, purity, and potency, whether for liquids, semi-solids, or solid oral dosages.
- Global Distribution Readiness Built for scale, our operations seamlessly integrate with the global supply chains of Fortune 500 companies. We offer robust packaging, serialization, and logistics support to ensure that products are ready for large-scale, international distribution immediately upon release.
Our Commitment to Excellence
- Uncompromising Quality & Compliance: Our facilities operate under strict cGMP guidelines and maintain rigorous quality control systems to ensure compliance with the FDA, EMA, and other global regulatory bodies.
- Scalability: We have the infrastructure and expertise to scale production rapidly, mitigating supply chain risks and ensuring our partners can meet market demand without interruption.
- Strategic Partnership: We act as an extension of your operations, offering transparent communication, dedicated project management, and collaborative problem-solving from tech transfer through commercialization.
Partner with us to secure a reliable, high-volume manufacturing pipeline for your most critical prescription and medical device medicines.
Customized Biologics
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
Imagine feeling more energetic every day, with sharper focus and improved resilience. NAD+ paired with sodium ascorbate and inositol injections supports cellular repair, enhances metabolic function, and boosts your immune system, while promoting balanced moods and healthy skin. Enjoy fewer burnouts and a renewed sense of vitality endorsed by science. Start now—experience the wellness difference that so many have already discovered for themselves and feel the strength of true health from within.
World Health Organization Global Reach & Regulatory Excellence
We facilitate the cGMP manufacture and global supply of finished drug products to premier markets, including North America, Europe, Asia, and the Middle East. Our commitment to compliance is validated by a flawless track record of inspections from the world’s most stringent global regulatory authorities, including:
- USFDA, MHRA (UK), & Health Canada
- ANVISA (Brazil) & PMDA (Japan)
- PIC/S, GMP, TFDA, and the Gulf Cooperation Council (GCC)
We Offer inhalationTherapeutics
Innovative Biotechnology Solutions at USA Biologics Manufacturer
Zeptide Pharma is an industry-leading sterile contract manufacturer specializing in high-quality respiratory and pulmonary care solutions. We provide FDA-compliant, state-of-the-art outsourcing manufacturing for hospitals, clinics, and healthcare providers nationwide.
Our facility is dedicated to the precise production and distribution of advanced Inhalation Devices. By delivering medication directly into the lungs, these devices allow for rapid absorption, targeted localized treatment, and fast relief for patients suffering from acute or chronic respiratory conditions.
Our Inhalation Device Manufacturing Capabilities
As a specialized outsourcing facility, Zeptide Pharma has the infrastructure and rigorous quality control processes required to manufacture and supply high-demand respiratory medications. Our production capabilities include:
- Metered-Dose Inhalers (MDIs): Reliable, propellant-based inhalers designed to deliver a specific amount of medication to the lungs in a short burst.
- Example Application: Albuterol for rapid asthma rescue and acute bronchospasm relief.
- Dry Powder Inhalers (DPIs): Advanced, breath-activated devices containing finely milled powdered medication. These require no propellant, relying on the patient's inhalation to deliver the drug deep into the lungs.
- Example Application: Fluticasone/Salmeterol for the long-term maintenance of asthma and Chronic Obstructive Pulmonary Disease (COPD).
- Soft Mist Inhalers (SMIs): Innovative, propellant-free liquid mist inhalers that generate a slow-moving, long-lasting aerosol cloud, making it easier for patients to inhale the medication without coordinating their breath with a button press.
- Example Application: Tiotropium for the daily maintenance and treatment of COPD.
Choosing Zeptide Pharma means partnering with a leader in respiratory drug manufacturing. We bridge the gap between complex pharmaceutical compounding and specialized device filling, ensuring that your healthcare facility has a consistent, reliable supply of critical inhalation therapies. Our commitment to strict 503(b) regulatory standards guarantees that every MDI, DPI, and SMI we produce meets the highest benchmarks for safety, sterility, and efficacy.
Contact us today to discuss your facility's respiratory medication needs and learn how our contract manufacturing services can support your patient care goals.
Join Our Team
Are you passionate about biotechnology and want to make a difference? Join our team of experts and help us tackle some of the world's biggest challenges. Check out our career opportunities.
Our Core Synthesis Capabilities
- Custom DNA Oligonucleotides: High-fidelity synthesis for gene assembly, diagnostic probes, and therapeutic applications.
- GMP RNA Synthesis: Specialized production of siRNA, sgRNA for CRISPR, and Aptamers, featuring extensive modification options.
- Modified Oligos: Expert incorporation of phosphorothioate (PS) linkages, 2’-OMe, 2’-F, and LNA to enhance stability and potency.
- Scalable Manufacturing: Seamless transition from R&D pilot batches (mg) to large-scale pharma-grade manufacturing (kg).
Contact Us: cdmo@tirzepatidepharm.com
Products Use
We specialize in the high-quality synthesis of sterile tides, 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 Click here to download our sterile peptides
10200 Plano Road, Dallas, TX, USA
Hours
Today | Closed |
