Popular on TelAve
- Human Resources Strategy Forum Celebrates 30 Years Empowering Leaders, Shaping the Next Generation of HR Innovators - 134
- Voices Rising Festival Celebrates Diversity in E. Islip, GRAMMY Governor LACHI performs!
- Allegiant Management Group Launches New Website Following Recent Rebranding
- Pikmykid School Messaging Empowering Schools Across the United States
- Dr. Stephen Shainbart, PHD, Highlights 5 Reasons to Discuss Family Therapy and Couples Counseling in Buffalo, NY
- The Enchanting Tree-Talking Wizards Are Back!
- Leading Arizona Real Estate Team Rebrands to SPACE, Marking a New Era in Real Estate Innovation
- AuthuSign Launches Mobile Web App, Empowering Users to Sign Documents on the Go
- Origination of Prince Oak's new alias and reasons of his change — the Eurasian Prince's newest nominal label is "Papa Eurasia"
- Use Bitcoin to Earn Bitcoin - Innovative Layer 2 Solution for Bitcoin
Similar on TelAve
- OpsVeda Announces General Availability Of Release 10.0 Of Its AI Powered Operations Command Center
- Celebrate Christmas 2024 with Exclusive Deals and Festive Offers
- See Our Earth Champions Environmental Education and Conservation Through Initiatives, Dad Hats and Mountain Hats
- Mrs Elemental® USA National Competition Introduces the Prestigious Panel of National Judges
- AI-driven money-saving tips: Black Friday shopping guide for 2024
- U.S. Beauty and Personal Care Market Booming with Rising Demand for Natural and Organic Products
- CCHR Backs UN & Senate Calls for DOJ Action on Coercive Psychiatric Practices
- Arthur Murray Dance Studio of Denville: Dance Your Way to Joy and Confidence in North Jersey
- Lifesaving Portable, AI Augmented Cardiac Monitoring Technology Poised for Commercial Launch Under New Industry Leader: Heartbeam: Stock Symbol: BEAT
- Cummings Graduate Institute for Behavioral Health Studies Celebrates 10 Years of Excellence in Integrated Behavioral Healthcare Education
Successful Completion of Australia's Therapeutic Goods Administration (TGA) Audit
TelAve News/10831842
SAN JOSE, Calif. - TelAve -- 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 TelAve News
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 TelAve News
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 TelAve News
- Bainbridge Custom Builders Launches to Redefine Custom Construction and Renovation in Philadelphia
- 76 FENCE Expands in North Carolina with Strategic Franchise Growth Led by Regional Developer Drew Myers
- See Our Earth Champions Environmental Education and Conservation Through Initiatives, Dad Hats and Mountain Hats
- NEW AI Launch! StarboxAI VI-Pro - Live Streaming System; Empowering 800 Merchants to Boost Sales to Over 2 Million Users: StarBox (Stock Symbol: STBX)
- El Ranchito Appoints New President
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 TelAve News
- Mrs Elemental® USA National Competition Introduces the Prestigious Panel of National Judges
- "House of War" Live Event & Podcast Series by Daniel Sadan Debuts This Week
- Balam and Transfera Unveil the World's First Remittance-as-a-Service Platform
- AI-driven money-saving tips: Black Friday shopping guide for 2024
- myStaze: Revolutionizing Live Music Streaming in the U.S. – Artists Earn 90% of Ticket Sales!
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 TelAve News
- Brooklyn Artist Allison Eden Studios Creates Presidential Portraits For Auction To Predict Election Results
- Arthur Murray Dance Studio of Denville: Dance Your Way to Joy and Confidence in North Jersey
- Arthur Murray Dance Studio of Napa: Discover the Joy of Dance in Wine Country
- Better Termite & Pest Control Marks 56 Years of Fall Pest Protection
- Halloween Spending Surge Drives U.S. Holiday Economy Growth in 2024
- People are Having Millions of Conversations with Friends and Family About Voting in the 2024 Election
- 5 Questions to Always Ask Roofing Companies in Memphis Before Hiring Them
- Lifesaving Portable, AI Augmented Cardiac Monitoring Technology Poised for Commercial Launch Under New Industry Leader: Heartbeam: Stock Symbol: BEAT
- KeysCaribbean Extends Advance Purchase Rate Discount Offer
- Kenneth Carnesi, Sr. COO Anaptyx Honored with 2024 Global Recognition Award
- Mount Dora Craft Fair and Plant Festival set to go on after hurricane hit
- ConverzAI Accelerates Industry Transformation with Groundbreaking AI-Powered Virtual Recruiters
- Cummings Graduate Institute for Behavioral Health Studies Celebrates 10 Years of Excellence in Integrated Behavioral Healthcare Education
- Significant Leaps Redefining Digital Commerce Connecting Merchants & Shoppers Rewarding Customers with Instant Cash Rebates (Stock Symbol: STBX)
- Michele Vreeland Explores the Supernatural with Haunting New Single 'Soul Collector,' Releasing October 25th, Just in Time for Halloween
- Megabits Per Second (Mbps) Explained: Speed Test For WiFi Shares Essential Insights for Boosting Internet Performance
- Jude Madrigal releases his first children's book, "The Trick-or-Treat Tree and the First Halloween."
- Powerful Leadership Transition to Optimize Highly Promising AI Platform RenovaroCube for Multi-Cancer Early Detection & Monitoring: Stock Symbol: RENB
- Lend a Hand Uganda-USA Hosts Its 10th Annual Poker Casino Night and Wine Tasting Fundraiser to Support Ugandan Children's Lunch Program
- Vantiva and Ann Mason Care Launch Innovative Remote-Enabled Home Care Service in the UK powered by the HomeSightTM Connected Care Solution