Student-run startup receives $2.2 million investment | The Daily Campus

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 an app-based ecosystem designed to nurture men’s health. This covers things like education, telehealth visits and lifestyle tracking.

Bastion was founded by Reza Amin and Khashayar Dashti. Amin is a UConn graduate student in the School of Engineering’s Master of Engineering in Global Entrepreneurship program. The company is based at UConn’s Technology Incubation Program (TIP) facility at UConn Health in Farmington.

The app will also feature diagnostic technology developed by Amin. This technology allows a user to test their fertility with their smartphone.

In December 2017, Peter J. Werth’s $22.5 million commitment to UConn established the Werth Institute. Werth is a philanthropist and founder and CEO of ChemWerth, Inc. This gift also meant Werth got a dorm named in his honor: the Peter J. Werth Tower, home to eight of UConn’s learning communities.

The telehealth portion of the app ecosystem is expected to launch in the near future. Amin’s smartphone testing technology will take longer to integrate as it requires FDA approval.

In addition to UConn, Bastion has also received support from Yale, MassChallenge, CTNext and Webster Bank.

More information about Bastion can be found at getbastion.com.

SMS Lifesciences India Ltd to divest partial stake in Mahi Drugs Pvt Ltd | EquityBulls

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 way of sale of equity shares held by the Company, to ChemWerth Inc., USA, Strategic Investor (“Proposed Transaction – 1”).

The board approved raising fresh equity in Mahi Drugs Private Limited, on Private Placement basis, to ChemWerth Inc., USA and its Associates (“Proposed Transaction – 2”).

Upon completion of the transactions, Mahi Drugs will cease to be a wholly-owned subsidiary of the Company, but shall continue as a Subsidiary Company with 60% stake of the post issued capital, with the Company.

The proposed transaction is likely to enhance the value for the various stakeholders.

Shares of SMS Lifesciences India Limited was last trading in BSE at Rs. 870.55 as compared to the previous close of Rs. 845.20. The total number of shares traded during the day was 540 in over 61 trades.

The stock hit an intraday high of Rs. 879.00 and intraday low of 857.80. The net turnover during the day was Rs. 467967.00.

 

Source : Equity Bulls

ChemWerth Files its 500th Drug Master File with FDA

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 company’s 500th DMF in its history. ChemWerth filed its first DMF in 1987 and continues to rank among world leaders for DMFs available for reference.

 

The achievement of 500 DMFs represents ChemWerth’s staying power over 38 years, and is a testament to the company’s regulatory and compliance prowess. ChemWerth’s average review cycle for DMF filings is just 0.79 in comparison with the industry average of 2.5 cycles. The efficiency in review cycles enables ChemWerth to turn DMFs around quickly to provide customers with an early-to-market advantage, which can lead to significant market share and revenue opportunity.

 

“Speed to market is paramount to succeed in the pharmaceutical landscape. Our regulatory experience and expertise helps us get the filing right the first time with 44% of the filings accepted in the initial pass,” said Peter Werth, president and founder, ChemWerth. “Our best-in-class regulatory team is dedicated to delivering exceptional value for our customers.”

 

ChemWerth provides high-quality APIs to regulated markets worldwide. Unlike trader-brokers, ChemWerth is a full-service API supplier with capabilities to support both large and small finished dosage companies. Through exclusive development and partnerships with API manufacturers, the company has a proprietary product selection process and extensive product portfolio.

 

About ChemWerth Inc.: Founded in 1982, ChemWerth is a world leader in developing and supplying specialty generic Active Pharmaceutical Ingredients (APIs) for human and animal health markets worldwide. The company continues to rank among world leaders for DMFs available for reference. ChemWerth is the regulatory agent for 25-plus FDA-approved facilities in the United States, Europe, India and China. The company sells 100-plus products in 38 countries around the globe. For more information about the company, please visit www.chemwerth.com.

ChemWerth and Enoray announce that Enoray has passed second U.S. FDA inspection

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 years, through extensive on-site training, audits, as well as providing sound technical support, to ensure that their operations are fully cGMP compliant. Enoray was established in 2010 and mainly produces FDA/EU grade Heparin, Enoxaparin, and other low molecular weight Heparins based on its own vertically integrated production operation from traceable porcine derived starting materials through API manufacturing in dedicated facilities. ChemWerth is Enoray’s U.S. Site Agent as well as its Regulatory Agent for multiple Drug Master Files (DMFs) including Heparin Crude, Heparin API, and Enoxaparin API.

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ChemWerth Continues to Excel with 59th DMF Available for Reference – Heparin Sodium

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 Administration (FDA) alerted healthcare providers of a change to the United States Pharmacopeia (USP) monograph for heparin. The increased scrutiny of heparin coming into the United States has created a market where only suppliers who can reliably source high quality heparin while tracing its origin will be able to successfully and safely supply the U.S. market.

ChemWerth is leveraging its 34 years of strong compliance standards to bring the industry a heparin source that is high quality, reliable and traceable. Every step of the heparin process throughout the supply chain is now required to be documented. The tracking and traceability measures put forth by the FDA and other regulatory bodies around the world fall right into ChemWerth’s business model “one world, one quality.”

Through extensive compliance expertise, ChemWerth has once again pioneered a reliable supply chain to which the final product can confidently be tracked to the initial source while having full control and overseeing the process along the way.

About ChemWerth, Inc.
ChemWerth is a world leader in developing and supplying specialty Generic Active Pharmaceutical Ingredients for the human and animal health markets. The company continues to rank #1 in DMFs Available for Reference among all other peer active pharmaceutical ingredient companies. ChemWerth is the regulatory agent for numerous FDA approved facilities in China, the United States, Europe and India. The company sells to the top generic pharmaceutical companies in the industry and sells products in 38 countries around the globe. For more information about the company please visit chemwerth.com.

ChemWerth Hits Milestone with 50th DMF Available For Reference, Commits to Strong Pipeline of Future APIs

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 continues to rank #1 in DMFs Available for Reference among all other peer active pharmaceutical ingredient companies.

“Contrary to an industry trend which has seen many competitors decrease their API development, we have stepped on the accelerator. We will continue to invest in specialty generic API products to support our customers around the globe, and we are committed to our vision of One World, One Quality generic APIs,” said Peter J. Werth, President and CEO, ChemWerth, Inc.

In addition to filing its 50th DMF available for reference, the company has 45 first to file APIs. Werth added, “Our customers have come to rely on ChemWerth to provide them with first to market advantage. This provides our customers with a big competitive edge and that continues to be a big reason for our success.”

ChemWerth Opens Distribution in Mexico and Central America

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 ingredients (API).

Read more here

China Honors Generic Pharmaceutical Visionary Peter Werth

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 one room home office in Connecticut. Peter Werth, at this point, a veteran in the generic pharmaceutical industry, saw an opportunity to produce USFDA quality pharmaceutical ingredients in China following cGMP. At the time, no one thought it was possible. The environment was too complicated and companies didn’t think sourcing quality API from China was realistic. Werth rolled up his sleeves and went to work. He became versed in the local market and worked tirelessly with the factories to get them up to cGMP certified quality. Fast forward 35 year later and sourcing from China is the industry norm.

In recognition of his accomplishments, Jinan Jinda bestowed on ChemWerth’s founder a public dedication, a statue in his likeness and a plaque highlighting his achievements and contributions to Jinda’s and China’s success in the industry. Congratulations Peter on the much deserved recognition!

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With over 30 years of experience, our responsibility has always been to helping our customers develop safe products for everyone across the globe with a ‘One World-One Quality’ approach that is the back bone of everything we do, every decision we make; making ChemWerth the ‘One Company’ for your API needs.

FDA Inspection Passes with Support from ChemWerth

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 program is working. The FDA arrived at these Asian manufacturing facilities virtually unannounced, ready to go. There has been a longstanding belief by many that overseas facilities have 2 months to prepare for an audit and this is the only reason they can pass an inspection. This theory has now been debunked – at least when you are discussing ChemWerth partner factories. ChemWerth, with over 30 years’ experience in China, expects and welcomes parity between the US and foreign facilities when it comes to FDA inspections.” stated Peter Werth, President and CEO of ChemWerth.

As anticipated, a byproduct of the GDUFA fees and the FDA’s “Commitment Letter” is the amount of notice the FDA provides for an overseas inspection. “We have now gone from 2 months’ lead time to a knock on the door.” The global transparency induced by new guidance’s like GDUFA and regulations like EU Directive 62, is quickly weeding out the chemical companies; leaving pharmaceutical companies that invest in compliance as the only viable option.

ChemWerth understands the importance of working at a high level of quality 365 days of the year and believes the “One World – One Quality” approach will lead to safer pharmaceuticals and increased credibility for the generic industry.