Media

News and Industry Happenings

ChemWerth’s media section is dedicated to providing company news, leadership insights and industry updates as it relates to the world of generic pharmaceuticals with the sole purpose of providing value to our customers.

  • A student-run startup at the University of Connecticut has received $2.2 million from the Peter J. Werth Institute for Entrepreneurship and Innovation. This is the largest investment in a student business the Werth Institute has given to date. The startup is Bastion Health, a men’s health venture. Bastion functions as[...] Read More
  • The Board of Directors of SMS Lifesciences India Ltd at their Meeting held on November 30, 2021, have considered and approved the disinvestment of partial equity shareholding of Mahi Drugs Private limited, a wholly owned subsidiary of the Company, not exceeding 10% in Mahi Drugs Private Limited, by[...] Read More
  • The Active Pharmaceutical Ingredient (API) end user supply chain security is a critical component to getting the finished dosage to market. Not only is this an expectation of the FDA, and US Customs, but supply chain security maintains continuity of product supply and uninterrupted business. A full-service generic[...] Read More
  • FOR IMMEDIATE RELEASE July 15, 2020   ChemWerth Files its 500th Drug Master File with FDA Woodbridge, Conn. – ChemWerth Inc., a leading supplier of generic Active Pharmaceutical Ingredients (APIs), filed a Drug Master File (DMF) with the Food and Drug Administration (FDA) for Clevidipine, making it the[...] Read More
  • This week, we bring you another interesting interview with Peter J. Werth, President and Chief Executive Officer of ChemWerth, a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company providing current Good Manufacturing Practices (cGMP) quality APIs to the regulated markets. Werth talks about how complexities[...] Read More
  • Peter J. Werth, President and Chief Executive Officer of ChemWerth, a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company providing current Good Manufacturing Practices (cGMP) quality APIs to the regulated markets, shares his view on how the government inspections have evolved over the past years.[...] Read More
  • July 2017: ChemWerth Inc. and Hubei Enoray Biopharmaceutical Co., Ltd. (Enoray) are pleased to announce that Enoray has passed their second U.S. FDA inspection in July, 2017 with no 483 issued. The FDA inspection focused on Heparin API. ChemWerth has worked closely with Enoray over the past three[...] Read More
  • Opening remarks given by Ed Vanderbeck, COO, ChemWerth. 2 day cGMP training seminar in Shanghai, China. November 3-4th, 2016. ChemWerth has spent the last 35 years revising the answer to that question. Understand, it needs to be put into context in an industry that is constantly evolving. The[...] Read More
  • Every year roughly ten million Americans receive the blood-thinning drug heparin, however in 2008 contaminated heparin resulted in about 350 adverse events and 150 deaths in the United States alone. Since then, heparin has attracted increasingly stringent attention from the FDA. In 2009 the U.S. Food and Drug[...] Read More
  • The company continues to rank #1 in DMFs Available for Reference ChemWerth, Inc., is pleased to announce that since the inception of Generic Drug User Fee Amendments (GDUFA) in 2012, the company has filed its 50th Drug Master File that the FDA has deemed as Available for Reference. The company[...] Read More
  • Supplier of APIs for generic drug formulations expands its reach ChemWerth, Inc. has expanded distribution into Mexico and Central America, striking a deal with IDEOS Servicios y Especialidades Quìmicas S.A. de C.V. in Corregidora, Querétaro. The company will serve as ChemWerth’s sales agent for its generic active pharmaceutical[...] Read More
  • Founder and chief executive of ChemWerth receives second honorary degree for his work to improve access to high quality, affordable generic medicines > Click to Read More Read More
  • FDAnews Drug Daily Bulletin Pharmaceuticals / Postmarket Safety / Submissions and Approvals Generics Demand Stronger Proscriptions in REMS Compliance Letter Guidance Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain bioequivalence testing batches for drugs protected by REMS product safety protocols.[...] Read More
  • Nobody likes to part with money – in business or otherwise. That being said, the idea of GDUFA fees makes sense. Long term, the fees are expected to fund faster review times, induce a higher level of compliance and safety, and even eliminate the submission of hollow applications,[...] Read More
  • In an unexpected reception fit for a king, China based API manufacturing facility, Jinan Jinda Pharmaceutical Chemistry Company, honored President and CEO of ChemWerth, Peter Werth as not only an industry “Pioneer and Mentor” but also as a “Philanthropist and Friend.” ChemWerth’s story began in 1979 in a[...] Read More
  • On August 2nd, the FDA published the Facility Fees for Fiscal Year 2015 and as anticipated they have increased from FY 2014. Due on October 1, 2014, the FDA has provided a high level overview of what is expected and the consequences of not following through on this[...] Read More
  • While the globalization of our business has posed both opportunities and challenges, companies that can demonstrate a track record of success and product excellence are thriving while those that are lacking are being weeded out. Your company’s reputation as a high quality, reliable drug source in good standing[...] Read More
  • With the June 20th deadline looming, there are many uncertainties regarding what will happen on June 21st. From published reports in the Pink Sheet and Generics Bulletin, the FDA has rejected about 40% of all ANDAs filed in fiscal year 2014. With the rush to meet the June[...] Read More
  • The FDA is making good on their promise. The dollars generated from GDUFA fees are funding the increased scrutiny of overseas generic drug suppliers. As a result, the quality of many finished dosage companies are making headlines, as exampled below. Medicines Made in India Set Off Safety Worries[...] Read More
  • One year after the implementation of GDUFA, the FDA has met their timeline by providing guidance on enhanced Refusal-to-Receive standards for ANDAs and related submissions. The Guidance for Industry ANDA Submissions – Refuse-to Receive Standards, published October 2013, provides clarification on the Refuse-to-Receive criteria which will improve the[...] Read More
  • Escape Hatch: New Legislation Seeks to Provide a Way Out for Some Companies Subject to GDUFA User Fees Article published on FDA Law Blog, December 2013 Possible Good News for Smaller Generic Drug Manufacturers: The Small Manufacturer Protection Act of 2013 proposing to waive or reduce GDUFA fees[...] Read More
  • December 2013 Woodbridge, CT/China – ChemWerth Inc. is pleased to announce two more successful overseas FDA audits in October. This adds up to 53 successful inspections in the past 5 years facilitated by ChemWerth. “We are particularly pleased with the most recent international inspections, which shows the GDUFA[...] Read More
  • 3-5 December 2013 One World. One Quality. One Company. ChemWerth is attending CPhI India and we would love to see you there. Join us December 3rd – 5th at the Bombay Convention and Exhibition Centre, Mumbai, India – Hall #1, Stand M32. Our Goal: To foster existing partnerships[...] Read More
  • As per the June 2013 draft guidance ANDAs: Stability Testing Drug Substances and Products, the FDA intends on using the ICH Stability Guidelines as a benchmark for ANDA and DMF Type II submissions. Initially this was set to take effect January 1, 2014. However, with the efforts of[...] Read More
  • According to a list published by the FDA on September 10, 2013 there are 41 companies that still have not paid their 2013 GDUFA facility fee. 17 out of those 41 companies are API manufacturers. Is your API partner one of them? GDUFA Facility Arrears List. ChemWerth is[...] Read More
  • Woodbridge, CT/Maharashtra, India — ChemWerth Inc. is pleased to announce Enaltec Laboratories has passed their first FDA overseas inspection with zero 483 being issued in August 2013.  This is truly a significant accomplishment for the Enaltec/ChemWerth collaboration and a positive indicator of the commitment to FDA compliance and[...] Read More
  • One World. One Quality. One Company. ChemWerth is attending CPhI Worldwide and we would love to see you there. Join us October 22nd-24th in Messe, Frankfurt, Germany in the Custom Manufacturing Hall at Chemcon Booth 50C70. Our Goal: To foster existing partnerships and develop new alliances with manufacturers[...] Read More
  • From left to right: DCAT Finance Officer Lyra Myers (Genentech), ChemWerth Founder and CEO Peter Werth, DCAT President Joan Connolly (Connovan Consulting) and DCAT Sr. Vice President and Annual Dinner Chair J. Tyson Popp (West Pharmaceutical Services) In honor of his company’s 30th year in business, Peter Werth,[...] Read More
  • Woodbridge, CT/Shanghai, China — ChemWerth Inc. (“ChemWerth”) is pleased to announce that Sichuan Credit-ChemWerth Pharmaceutical Co., Ltd. (“Credit-ChemWerth”) has passed FDA overseas inspection with zero 483 being issued in June 2012. Established in July 2007, Credit-ChemWerth is a joint venture API manufacturer between ChemWerth, a full service generic[...] Read More
  • Woodbridge, CT/Shanghai, China — ChemWerth Inc. is pleased to announce that Chengdu Shengnuo Bio-Pharmaceutical Co., Ltd. (Shengnuo) new facility has passed FDA overseas inspection with zero 483 being issued in May 2012.  ChemWerth is the exclusive regulatory and sales agent for Shengnuo. Shengnuo, founded in 2004, commissioned a[...] Read More
  • Volume 90 Issue 3 | January 16, 2012 | p. 22 | C&EN Talks With Peter Werth American Entrepreneur Reflects on More Than 30 Years of Sourcing Pharmaceutical Ingredients from China By Jean-François Tremblay ChemWerth Founder and CEO Peter Werth When Peter Werth first traveled to China to[...] Read More