USA Tirzepatide Manufacturer
USA Tirzepatide Manufacturer
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  • More
    • Home
    • Expertise
      • Expertise
      • Capabilities
      • Custom Peptides
      • All Synthesizers
    • GMP Production
      • GMP Production
      • Oligonucleotide
    • Our Products
      • Peptides
      • Tirzepatide
      • Semaglutide
      • Cagrillintide
      • Retatrutide
      • Heterocyclic Compounds
      • Carbohydrates
      • High Potent API (HPAPIs)
      • Steroid & Hormone etc
      • Peptides & PDCs
      • Labelled Compounds
      • Iron Carbohydrate Complex
      • Polymers & Macrocycles
    • Contact
  • Home
  • Expertise
    • Expertise
    • Capabilities
    • Custom Peptides
    • All Synthesizers
  • GMP Production
    • GMP Production
    • Oligonucleotide
  • Our Products
    • Peptides
    • Tirzepatide
    • Semaglutide
    • Cagrillintide
    • Retatrutide
    • Heterocyclic Compounds
    • Carbohydrates
    • High Potent API (HPAPIs)
    • Steroid & Hormone etc
    • Peptides & PDCs
    • Labelled Compounds
    • Iron Carbohydrate Complex
    • Polymers & Macrocycles
  • Contact

GMP Production

 Experience unmatched quality and dependability with Bachem Pharm's manufacturing facilities located in the U.S. Our production processes are carefully aligned with Good Manufacturing Practice (GMP) standards set by regulatory bodies, including the Food and Drug Administration (FDA). 

 

Our peptides API formulations are FDA registered and not affiliated, endorsed, or intended to replace Eli Lilly, Novo Nordisk, or other companies' FDA-approved brands such as Victoza, Saxenda, Byetta, Ozempic, Rybelsus, Wegovy, Adlyxin, Trulicity, or Mounjaro.

Purpose:  GLP-1 w/ methylated Pyridoxine, Glycine, NAD+, and B12 is our most successful product! With combined, dual-acting appetite-suppressing properties, users have found the most success.   


Rethink-Revise-Customized GLP-1

Custom Formulation

Bachem Pharma GLP-1 Peptide can be customized with B12 API, Thiamine, Pyridoxine, NAD+, and L-Carnitine. FDA-registered peptides are available for rebranding and for commercial distribution with Vitamin B12-100mcg API. Manufactured with approved DMF according to the Federal Food, Drug, and Cosmetic Act. The NDC number is activated upon order.

A Custom Peptide therapy kit contains: 

  • 2-10ml Bacteriostatic water
  • 4-Vials API Peptide
  • 30cts Oral Peptide (optional)
  • 1-Storage Pen
  • 4-Alcohol Pads
  • 4-Mixing needles
  • 4-Subcutaneous pen needle
  • 1-Instruction booklet

Customized GLP-1 Injection w/ Vitamin B1 (1000mcg), B6 (1000mcg),B12( 100mcg/mL), L-Carnitine (100mg), and NAD+ (20mg) plus (optional capsule form of 30cts per bottle).


Other Peptides we contract manufacture are:

  • Muscle enhancement Peptides-Sermorelin 
  • Ipamorelin with CJC-1295 Products
  • · Age reversal GHK-Cu     Youth Molecule 
  • · Glutathione Super-antioxidant      Peptide
  • · Anti-inflammatory injury      healing BPC-157
  • · Self-enhancement and muscle      growth TB-500
  • · Cognitive health MOTS-C
  • · Regenerative medicine NAD+
  • · Skin cells renewal peptide Epitalon

Bioavailable Oral GLP-1

The addition of other minerals such as methylated forms of Vitamin B1(Thiamin), B6(Pyridoxine), NAD and vitamin B12 is intended to help to improve energy levels, boost metabolism and help burn fat, improve fatigue, muscle loss, or neuropathy—common concerns during weight loss or diabetes treatment—and may offer metabolic, neurological, and musculoskeletal benefits.

  

Our Customizable APIs are:

Dulaglutide

Tirzepatide

Semaglutide

Retatrutide

Cagrillintide

Exenatide

Premarketing Analytical Test

Bachem Pharma conducts extensive Pre-marketing peptide tests and analytical chemistry on all peptide entities and provides these test reports: 

  • Circular Dichroism Spectrometer CD analytical report that      confirms the molecular structure, intermolecular interactions, and kinetic      analysis of each peptide. We evaluate the secondary structure,      folding and binding properties of the peptides. 
  • High Resolution Mass Spectrometer      (HRMS) analysis report, which is more accurate and reliable, along with the      Prep-HPLC purity test report. High-resolution mass spectrometry (HRMS) is      an analytical chemistry technique that can distinguish between the      molecular masses of compounds and provide high-resolution and high-quality      mass spectral data.
  • Amino Acid Analysis report. We conduct amino acid      analysis on finished peptide drugs using Biochrom30+, German MembraPure      A300. It is an instrument used to determine the composition or content of      amino acids in proteins, peptides, and other pharmaceutical preparations.
  • Comprehensive Certificate of      Analysis showing details of all the test results with a full spectral peptide      scan, showing the absorbance levels across the range of wavelength.

In addition to the above, we provide item reports within 30 days of order, FDA-DMF for ANDA registration or for clinical trials

GMP-Qualified Manufacturing Technology

Bachem Pharm's production facilities are equipped with cutting-edge technology for solvent supply, peptide synthesis, purification, and the isolation of active ingredients and intermediates. With GMP-compliant equipment and validated cleaning procedures, you can be confident in receiving consistent excellence in every batch.


Our formula for success lies in fostering a close partnership with our clients. Through effective collaboration, we tailor process development packages to meet ambitious timelines, delivering phase-appropriate, high-quality products with unmatched efficiency.   


Our emphasis is on supplying the components and systems necessary for the delivery of peptide APIs, which are designed to target specific areas within the body, preserve their stability, and improve their effectiveness. For tailored peptides, we offer a variety of specialties for complex conditions, including injectables. 



Elevating GMP Manufacturing Excellence

Peptide and oligonucleotide synthesis (“Upstream”)

Our diverse capabilities, expert advice, and dedication to quality guarantee smooth scalability, enhanced equipment utilization, and improved efficiency throughout the production process. Collaborating with TirzPharm provides you with: 


 Diverse production capabilities: This includes solution-phase and solid-phase synthesis reactors, along with innovative methods such as Molecular Modifications.


Smooth scalability: Effortless scalability is achievable with solution-phase reactors reaching up to 8000 litres and solid-phase peptide synthesis (SPPS) reactors up to 500 litres. Larger options are currently under development, with a new facility in Bubendorf offering sizes up to 1000 litres. 


Enhanced equipment: Rely on our GMP-qualified equipment, which includes OligoPilot synthesizers and custom-designed cleavage and deprotection equipment trains, ensuring precise control and safety when handling hazardous reagents. 


 Improved efficiency and quality: Our sophisticated automation and data management systems, featuring a Manufacturing Execution System and a process data historian, enhance efficiency and guarantee superior quality. 


Dedication to quality: By adhering to Quality by Design principles and incorporating in-process controls and process analytical technology, we consistently achieve high-quality outcomes. 


Purification and Isolation of Peptides and Oligonucleotides

 Bachem Pharm is committed to the ongoing enhancement and modernization of its purification equipment to satisfy the increasing demand for bulk peptide and oligonucleotide pharmaceuticals. In addition, our team will offer you: 


 Advanced purification methods: Employ a variety of advanced purification techniques, such as preparative high-performance liquid chromatography (HPLC), ion exchange (IEX), size-exclusion chromatography (SEC), and ultra-filtration (UF/TFF).  Scalable manufacturing: Our equipment facilitates highly efficient or continuous production of ultra-pure products in multi-kg quantities per batch. 


Precise control and scalability: Dynamic axial compression (DAC) stainless steel columns with diameters of up to 60 cm guarantee optimal performance during the separation phase.  Stringent microbiological control: ISO 8 and ISO 7 clean rooms equipped with HEPA-filtered air uphold rigorous microbiological control standards.


Safety measures: Down-flow booths reduce microbial contamination, and highly active pharmaceutical ingredients are managed in safety workbenches or isolators rated up to OEB level 4.  


Controlled isolation: Meticulously controlled isolation processes, including precipitation, crystallization, and lyophilization of intermediates and final active pharmaceutical ingredients (API), ensure that predefined physicochemical properties are achieved. Multiple lyophilisers for quality assurance: A range of lyophilisers of different sizes ensures product integrity and quality across all batches. 



Benefit from our GMP small molecule manufacturing

Bachem Pharm has capabilities for the production of GMP small molecules at the site in Texas. We offer:

  • Process development
  • Chiral synthesis
  • Heterocyclic chemistry
  • Metal-catalysed reactions
  • Hydrogenations
  • Oxidations and reductions using various reagents
  • Enzymatic reactions
  • High-pressure reactions
  • keywords: semaglutide usa supplier, glp-1 peptides tirzepatide weight loss

 Good Manufacturing Practices (GMP) are critical standards established by regulatory bodies such as the FDA, EMA, and Swiss Medic. These guidelines ensure that manufacturers follow specific practices to maintain the consistent high quality of their products. Compliance with GMP regulations is necessary for companies to secure authorization and licensing for their manufactured goods. 


 Continuous chromatography, referred to as Multi-column countercurrent solvent gradient purification (MSCGP), has similarities with HPLC but is distinguished by its fully automated process, the use of multiple columns, and a continuous loading mechanism. This advanced technique guarantees high product yields while preserving purity levels and generally decreases solvent usage, thereby supporting environmentally sustainable chemistry practices. 


 

The large-scale purification of TIDES utilizing Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) under GMP standards ensures the effective and high-quality production of therapeutic peptides. MCSGP enhances the purification process by separating complex mixtures through the use of multiple columns and solvent gradients, thereby improving both purity and yield. When conducted under GMP, this method adheres to rigorous regulatory standards, ensuring that the final product is safe, effective, and appropriate for clinical applications, positioning it as a vital technology for large-scale peptide manufacturing.


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