Popular on s4story
- People & Stories/Gente y Cuentos Announces New Board Leadership & Corporate Partnership Initiative - 129
- Mensa identifies best board games of 2025 - 125
- Electives Appoints DraftKings' CPO Linda Aiello to Board Amid Record Quarter - 102
- Is Billboard Advertising Still Effective in 2025?
- Two exciting new fantasy & adventure books are published
- MAJOR New release of Krypto500 (ELF-HF) Sigint - COMINT software
- Mission 3A Establishes Healthcare Advisory Board with Addition of Industry Leaders Patrick Fisher, Kevin Cordell, and Dr. Greg Berlet
- "The Eyes Have It" a Short Story by Philip K. Dick Now Available on Audiobook
- Fairfield Inn by Marriott Scottsdale Old Town Opens
- New Build-to-Suit VA Medical Office Facility Coming to Highland Heights, KY
Similar on s4story
- NBA Champion Lamar Odom Launches Anti-Addiction Meme Coin, Ushering in a Disruptive Innovation in Web3
- Pathways to Adulthood Conference May 17 at Melville Marriott Honoring NYS Assembly Member Jodi Giglio, Suffolk County Legislator Nick Caracappa
- L2 Aviation Celebrates Grand Opening of New Facility at Cincinnati/Northern Kentucky International Airport (CVG)
- Fray Fitness Launches Memorial Day Sale and Veteran Organization Giveaway
- ImagineX, in Collaboration with Qualys, Launches New mROC Services to Transform Enterprise Cyber Risk Management
- Hubei Heavy Equipment Makes a Striking Appearance at CIMT and Competes with International Brands
- 20 Patents Issued Worldwide, Cementing Company Leadership. First Ever Cable-Free 12-Lead ECG: HeartBeam, Inc. (Stock Symbol: BEAT)
- Congressional Men's Health Caucus Shows Bipartisan Consensus and Focus on Prevention, Mental Health, and Closing the Lifespan Gap
- $4.3 Million Patent Application Waiver Fee Granted by FDA on New Drug Application Fee for Treatment Addressing Suicidal Depression & PTSD: NRX Pharma
- Whistleblower Claims Dental Patient Deaths Likely Due to Book Ban
Successful Completion of Australia's Therapeutic Goods Administration (TGA) Audit
S For Story/10628251
SAN JOSE, Calif. - s4story -- 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 S For Story
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 S For Story
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 S For Story
- NBA Champion Lamar Odom Launches Anti-Addiction Meme Coin, Ushering in a Disruptive Innovation in Web3
- Aureli Construction Sets the Standard for Seamless Home Additions in Greater Boston
- Do You Know Why Nobody Sits Like the French?
- ScreenPoints Puts Film Investors in the Credits—and in the Money With New FinTech Platform
- Pathways to Adulthood Conference May 17 at Melville Marriott Honoring NYS Assembly Member Jodi Giglio, Suffolk County Legislator Nick Caracappa
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 S For Story
- Adster Techologies awarded US Patent for breakthrough innovation in reducing latency in Ad Serving
- Robert Fabbio Inducted into the Austin Technology Council Hall of Fame
- Cybersecurity is Protecting Your Personal Information and Your Portfolio
- L2 Aviation Celebrates Grand Opening of New Facility at Cincinnati/Northern Kentucky International Airport (CVG)
- Managing Summer Staffing Surges with Confidence: Why Name Badges Are a Must for Seasonal Success
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.
0 Comments
Latest on S For Story
- 20 Patents Issued Worldwide, Cementing Company Leadership. First Ever Cable-Free 12-Lead ECG: HeartBeam, Inc. (Stock Symbol: BEAT)
- NASDAQ Uplisting for Higher Market Exposure and Wide Corporate Benefits to AI Boosted Marketing Company On Track Towards $1 Billion Revenue by 2027
- Congressional Men's Health Caucus Shows Bipartisan Consensus and Focus on Prevention, Mental Health, and Closing the Lifespan Gap
- DuoKey, Axiomtek and Blue Edge Network Partner to Enhance Smart Cities with Privacy-Preserving Urban Safeguarding and Fleet Management
- Arlina A.'s A LETTER TO PAWTONE Explores Childhood Innocence and the Moments That Shape Us
- Austin Keen Joins WakeFX RopePal as Official Brand Ambassador
- Bonelli Systems Expands Managed IT Services Nationwide, Leveraging Microsoft Azure Expertise
- $4.3 Million Patent Application Waiver Fee Granted by FDA on New Drug Application Fee for Treatment Addressing Suicidal Depression & PTSD: NRX Pharma
- Whistleblower Claims Dental Patient Deaths Likely Due to Book Ban
- xREnergy up as much as +3,094,634% on first day listed on the XRP Ledger. Ticker : $XRE
- Psychiatry's Legacy of Racism and Coercion Highlighted in Restraint Deaths
- New Book 'Cybersecurity Leadership' Guides SME Leaders to Make Smart, Strategic Security Decisions
- "Stop scrolling and start watching" - Beloved film recommendation site Criticker gets a major makeover
- Green Energy Solar Expands with New Offices in Port St. Lucie, West Palm Beach, and Orlando
- Events by Dubsdread Expands Services to The Venue at Lake Lily
- London Gala Emphasizes Trade, FDI and Ongoing Cooperation
- Walk 4 Christ: A 52-Week Journey to Transform Your Life, Body, and Faith
- Sahit Muja Launches Trillion-Dollar Green Revolution with 10 Groundbreaking Cryptos
- Free and Low-Cost Dental Care Now Available in London Through the Canadian Dental Care Plan (CDCP)
- Garden State Gay Socials Turns One: 1st Birthday Celebration for Gay Men Who Want Real Connection