Trending...
- 5X Gross Margin Improvement to Beat EPS Consensus; $54.6 Million 10-Year Contract Award Puts Cybersecurity Leader on Path to a $30 Million Run Rate
- New Book, The KI of Marketing, Helps Small Businesses Grow Without Trying to Outspend Bigger Competitors
- Black Dog Venture Partners and VC Fast Pitch to Host "San Francisco Investors and Innovators" Networking Event
SAN JOSE, Calif. - ncarol.com -- CPC announces the completion of a rigorous four-day audit conducted by Australia's Therapeutic Goods Administration (TGA), the country's government authority responsible for evaluating, assessing, and monitoring approved products defined as therapeutic goods. As a globally recognized peptide and oligonucleotide manufacturer, with our facilities built and operated to WHO GMP, FDA 21 CFR 210/211, and ICH Q7 standards, this audit marks a significant milestone in the company's ongoing commitment to ensuring the highest standards of quality and compliance. Our manufacturing facility in Hangzhou, China, was awarded an A2 compliance rating. This inspection certifies Good Manufacturing Practice (GMP) compliance of three commercial peptide active pharmaceutical ingredients (APIs). This achievement underscores our commitment to maintaining the highest quality standards in peptide production and ensures that our products meet stringent international regulatory requirements.
More on ncarol.com
About CPC Scientific.
Founded in 2001, we are the third largest peptide-focused contract research, development, and manufacturing organization ("CRDMO") worldwide in the of terms of sales revenue in 2023, according to Frost & Sullivan. We are also considered one of the most comprehensive peptide-focused CRDMO globally (Frost & Sullivan), offering complete life-cycle support from early-discovery, pre-clinical research and clinical development to commercial production.
Our operations in China are conducted in our facility located at No. 69, Street 12 of Qiantang District, Hangzhou ("Qiantang Site"), situated on our approximately 26,000 square meter CGMP campus. The constructed manufacturing CGMP facility has a gross floor area ("GFA") of over 15,000 square meters. Our production facilities adhere rigorously to CGMP as mandated by major regulatory authorities globally, including the U.S. Food and Drug Administration ("FDA"), National Medical Products Administration ("NMPA"), European Medicines Agency ("EMA"), Therapeutic Goods Administration ("TGA"), and Korean Ministry of Food and Drug Safety ("MFDA"). We have successfully passed four FDA audits without receiving FDA-483 observations (FDA notice highlighting regulatory violations found during an inspection) as of the Latest Practicable Date ("LPD"). In addition, our facility holds ISO9001 and ISO13485 certifications for quality management systems.
More on ncarol.com
In addition to the Qiantang Site, we also have GMP production facilities under construction in the United States and Hangzhou, China, with a total GFA of 4,000 and 26,700 square meters, respectively. All our production facilities are equipped with advanced equipment and instrumentation supplied by top-tier equipment suppliers such as Agilent, Waters, Thermo Fisher, Cytiva, Jianbang, and Hanbang.
website
More on ncarol.com
- RAS AP Consulting Spotlights Managed AP Governance™ at Esker All Access
- ANSI BSR Upholds Appeal of AFDE Member Andrew Sulner, MSFS, JD, finding the AAFS Academy Standards Board (ASB) Violated ANSI Essential Requirements
- Kentucky's Plane Crash Data Lands Far from the State's Busiest Airports
- StockResearch AI Initiates Coverage on Apple (AAPL) With New Report Examining Valuation, AI Strategy and Future Growth
- Netberg Announces the Aurora X2 Switch Series, Built on Xsight Labs' Programmable X2 Silicon
About CPC Scientific.
Founded in 2001, we are the third largest peptide-focused contract research, development, and manufacturing organization ("CRDMO") worldwide in the of terms of sales revenue in 2023, according to Frost & Sullivan. We are also considered one of the most comprehensive peptide-focused CRDMO globally (Frost & Sullivan), offering complete life-cycle support from early-discovery, pre-clinical research and clinical development to commercial production.
Our operations in China are conducted in our facility located at No. 69, Street 12 of Qiantang District, Hangzhou ("Qiantang Site"), situated on our approximately 26,000 square meter CGMP campus. The constructed manufacturing CGMP facility has a gross floor area ("GFA") of over 15,000 square meters. Our production facilities adhere rigorously to CGMP as mandated by major regulatory authorities globally, including the U.S. Food and Drug Administration ("FDA"), National Medical Products Administration ("NMPA"), European Medicines Agency ("EMA"), Therapeutic Goods Administration ("TGA"), and Korean Ministry of Food and Drug Safety ("MFDA"). We have successfully passed four FDA audits without receiving FDA-483 observations (FDA notice highlighting regulatory violations found during an inspection) as of the Latest Practicable Date ("LPD"). In addition, our facility holds ISO9001 and ISO13485 certifications for quality management systems.
More on ncarol.com
- Pete Verbica: America Needs Statesmanship and Common Sense — Not a Cult of Personality
- Heidi G. Villari of The Villari Firm, PLLC Recognized in The Best Lawyers in America 2027 for Construction Law and Personal Injury Litigation
- When the Coroner's Report Isn't Enough: Colorado Families Turn to Private Autopsy for Closure
- Belmont, NC Emerges as More Than a Charlotte Alternative for Homebuyers
- Nearly One-Third of CRE Asset Managers Make Major Capital Decisions on Gut Instinct, New Survey Finds
In addition to the Qiantang Site, we also have GMP production facilities under construction in the United States and Hangzhou, China, with a total GFA of 4,000 and 26,700 square meters, respectively. All our production facilities are equipped with advanced equipment and instrumentation supplied by top-tier equipment suppliers such as Agilent, Waters, Thermo Fisher, Cytiva, Jianbang, and Hanbang.
website
Source: CPC Scientific Inc.
Filed Under: Health, Manufacturing
0 Comments
Latest on ncarol.com
- Food Journal Magazine Focuses Its Los Angeles Dining Coverage Across Three Editorial Verticals
- Where Do Missouri Plane Crashes Really Happen? Not Where You'd Think
- LCC Asia Pacific Sponsors CubeSatPlus 2026 at UNSW Sydney
- The Sharon at SouthPark Breaks Ground on $178 Million Expansion
- Pattern Recognition In The Arts
- Real Estate Syndication Attorney Tilden Moschetti Releases The Real Estate Private Equity Blueprint
- 5X Gross Margin Improvement to Beat EPS Consensus; $54.6 Million 10-Year Contract Award Puts Cybersecurity Leader on Path to a $30 Million Run Rate
- Couture Master Perfumer JoAnne Bassett Unveils All-Natural Parfum in Oil Collection in Gift Box
- Independent Colbert Packaging Thrives Amid Industrywide Consolidation
- Free Commercial Glass Estimating and Code Compliance Tools Launched by Landmark Construction - The Leading Glass Company in Los Angeles
- Tallahassee Million-Dollar Home Sales Rise in 2026 as Median Selling Time More Than Doubles
- STEM For Kids® Unveil Turn-Key "Screen-Smart" Solution to Bridge Teacher Preparedness Gaps in Texas
- Award-Winning Couture Master Perfumer JoAnne Bassett Launches All-Natural DIY Perfume Making Kits
- Couture Master Perfumer JoAnne Bassett Offers Rare Opportunity to Acquire 70 Formula Perfume Codex
- Slotozilla Reports Strong Growth in Q2 2026
- Flexible Plan Investments Names Carl Resnick President
- Paula Josephine Sadler Releases "Imagine" on 24th Anniversary of Sobriety
- Ritz-Carlton Residences Houston Generates Strong Early New Construction Sales at 2120 Post Oak Blvd
- No Sugar Baker Continues National Growth with Seattle Market Expansion Across Washington, Idaho, and Alaska
- The Refugee Archive Launches Campaign to Preserve 21 Female-Headed Household Oral Histories in Rebel-Controlled Goma
