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https://www.chinesepeptideco.com/gmp-services/

CPC is a leading peptide CRDMO specializing in CGMP peptide synthesis. With over 20 years of experience in the peptide industry, we have established ourselves as a reputable supplier of high-quality peptides to researchers and pharmaceutical businesses worldwide. Our expertise lies in synthetic GMP peptide manufacturing for early- and late-phase development, as well as commercial manufacture. With a team of experienced peptide professionals and a strong track record in peptide design and large-scale manufacturing spanning over 30 years, CPC is your trusted go-to CRDMO for all your GMP peptide needs.

Why Choose CPC GMP Services?
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Manufacturing Expertise
We have been gmp peptide manufacturing for more than 20 years.

Methods of fragment condensation, ligation chemistry, SPPS, and LPPS.

Any of the defensive tactics (Boc, Fmoc, Cbz) may be used.

Utilized are cutting-edge purification and isolation methods.

A solid commercial process is ensured through skill in process development and scale-up.

Large-scale production has been tailored to complex sequences and peptide changes.

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cGMP Compliance
The gmp document services program at CPC Scientific complies with FDA/EU cGMP regulations to the letter.

ICH Q7 (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and Code of Federal Regulations Part 210/211 (21 CFR 210/211) Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, ICH Harmonized Tripartite Guideline Q7)

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Regulatory Support
Full support for your international and US IND and NDA filings.

All necessary governmental backing for your peptide APIs.

Consultation on phase-appropriate control systems

Information required for the compilation of the Chemistry, Manufacturing, and Controls (CMC) section of the New Drug Application (NDA) and Investigatory New Drug (IND) submissions

Compilation and submission of drug master files (DMF)

Product reviews every year

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Quick Delivery Time
A key factor in the success of your project is delivery timing. We are able to accept new projects and begin production earlier than many other top peptide producers because of our flexibility and capacity.

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Manufacturing Capacity
From early research (mg amounts) through commercialization (100 kg), CPC Scientific has the GMP peptide manufacturing capabilities to assist your GMP initiatives. We also have the adaptability, pre-approved workspace, and strong supply chain needed to quickly add new projects to our pipeline of production.

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Complete Life Cycle Support
At every stage of development, including the discovery phase, preclinical development, clinical trials, and commercial manufacturing, CPC Scientific is by your side.

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Confidentiality
The primary driver of our business's expansion and success is the delight of our clients. Maintaining the security of trade secrets and sensitive information provided to us by our customers is a crucial component. All private information that we obtain while providing any of our custom services will be completely secret, CPC Scientific guarantees.

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Proven Track Record
CPC Scientific has more than 20 years of experience working with peptides and a demonstrated track record in process development, bulk-scale manufacture, and bespoke synthesis. With over 100 clinical development projects and 9 commercial products, we have experience in both early- and late-phase projects.

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US-Based Manufacturing
The United States will be protected from experiencing shortages of essential pharmaceutical supplies by developing robust supply networks. Beginning in 2024, the production facility in Rocklin, California, owned by CPC Scientific, will handle the crucial supply chain requirements for peptide APIs.

For more information about cgmp registered facility and gmp quality control, please feel free to contact us!

There are many gmp companies, but we are one of the best choices for you.

If you are looking for a reliable gmp factory, don't hesitate to contact us!

For more information about polypeptide cdmo, please feel free to contact us!