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AmbioPharm

AmbioPharm, a global peptide CDMO, was founded in 2005 and is headquartered in North Augusta, South Carolina, USA specializing in developing highly efficient manufacturing processes for peptide-based Active Pharmaceutical Ingredients (APIs) at very small to very large scales. In our manufacturing facilities in South Carolina, USA and Shanghai, China, we manufacture New Chemical Entities (NCEs) and generic peptide APIs under cGMP for clients worldwide. Both facilities have been inspected multiple times by the FDA with excellent outcomes. Ambio is a drug development company with a rich and growing pipeline of proprietary drug development programs for bioequivalent and biosimilar versions of the world’s best-selling peptide drugs. Ambio Pharmaceuticals is the parent company of AmbioPharm, Inc. and Ambio, Inc.

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Pharmaceutical Manufacturing 164 Employees Found Shanghai, China Founded 2005 10 Similar Companies
164 Employees Found
86% Email Coverage
$65.0M Est Revenue
2 Office HQ
10 Similar Companies
Jun '26 Last Verified

AmbioPharm – Company Information

Pharmaceutical Manufacturing
Founded 2005
51-200 employees View all
1024 Dittman Court, North Augusta, SC, 29842, US
www.ambiopharm.com
Process Development GMP Peptides Regulatory Support Biochemicals Peptides Custom Peptide Synthesis Generic Peptides NCEs Cosmetic Peptides Peptide Active Pharmaceutical Ingredients (APIs) Clinical Peptides Preclinical Manufacturing Analytical Methods Support Commercial Peptide Manufacturing GMP Peptide Manufacturing NCE peptides Agricultural peptides Peptide Contract Development & Manufacturing Organization (CDMO)

Frequently asked questions about AmbioPharm

What is AmbioPharm email format?

The widely used AmbioPharm email format is {first}.{last} (e.g. john.smith@ambiopharm.com) with 85.71% adoption across the company.

What is AmbioPharm customer service number?

To contact AmbioPharm customer service number in your country click here to find.

Who is the CEO of AmbioPharm?

Brian Gregg is the CEO of AmbioPharm.

Who are the decision makers in AmbioPharm?

The decision makers in AmbioPharm are Brian Gregg, Tim Nieters, Holdemhook Trust, etc. Click to Find AmbioPharm decision makers emails.

What services does AmbioPharm offer as a peptide CDMO?

AmbioPharm specializes in a wide range of services as a Contract Development and Manufacturing Organization (CDMO) for peptides. Their offerings include process development, GMP peptide manufacturing, regulatory support, and analytical methods support. They cater to various industries, including pharmaceuticals, cosmetics, and agriculture, providing custom peptide synthesis, generic peptides, and peptide active pharmaceutical ingredients (APIs) for clinical and preclinical applications.

What is the significance of GMP in peptide manufacturing at AmbioPharm?

GMP, or Good Manufacturing Practice, is crucial in the pharmaceutical industry to ensure that products are consistently produced and controlled according to quality standards. At AmbioPharm, GMP compliance guarantees that their peptide manufacturing processes meet regulatory requirements, ensuring the safety, efficacy, and quality of peptide-based APIs. This is particularly important for clients developing peptides for clinical trials and commercial use.

Can AmbioPharm assist with regulatory support for peptide products?

Yes, AmbioPharm provides comprehensive regulatory support for peptide products. Their team is experienced in navigating the complex regulatory landscape, helping clients prepare the necessary documentation for submissions to regulatory agencies. This includes guidance on compliance with FDA regulations and other international standards, ensuring that clients can successfully bring their peptide products to market.

What types of peptides can AmbioPharm manufacture?

AmbioPharm is capable of manufacturing a wide variety of peptides, including custom peptides, generic peptides, and peptide APIs for new chemical entities (NCEs). They also produce cosmetic peptides and agricultural peptides. Their expertise spans across different applications, from clinical and preclinical manufacturing to commercial peptide production, allowing them to meet diverse client needs.

How does AmbioPharm ensure the quality of its peptide products?

AmbioPharm employs rigorous quality control measures throughout the peptide manufacturing process. This includes the use of validated analytical methods to test the purity, identity, and potency of the peptides produced. Their adherence to GMP guidelines and continuous monitoring of manufacturing processes further ensure that the peptides meet the highest quality standards required for pharmaceutical and other applications.

What industries does AmbioPharm serve?

AmbioPharm serves a variety of industries, including pharmaceuticals, cosmetics, and agriculture. They provide tailored peptide solutions for each sector, whether it’s developing peptide APIs for drug development, creating cosmetic peptides for skincare products, or synthesizing agricultural peptides for crop protection. Their broad expertise allows them to support clients across multiple fields with specialized peptide manufacturing and development services.