April 2023 - rfxcel.com

Spherity and Antares Vision Group further partnership to ensure life sciences customers will comply with upcoming DSCSA regulations

Antares Vision Group, through rfxcel technology, has integrated Spherity’s Credentialing Service into its DSCSA solutions to verify authorized trading partners’ identities and licensing in all regulated interactions.

Reno, Nevada, April 25, 2023 — Spherity, a German leading provider of digital wallet and credentialing solutions, and Antares Vision Group, an Italian multinational and a leading provider of track and trace and quality control systems, are continuing a partnership that helps ensure life sciences customers comply with this year’s U.S. Drug Supply Chain Security Act (DSCSA) regulations.

By November 27, 2023, manufacturers, distributors, dispensers, and other actors in the life sciences supply chain must prove that they are legitimate organizations, or authorized trading partners (ATPs), as defined by the DSCSA.

The two companies first partnered in 2021, when Spherity’s Credentialing Solution, CARO, was integrated into the Group’s Verification Router Service (VRS) solution, enabled by rfxcel technologies, to allow life science customers to confirm their ATPs status. The combined solution also allows customers to exchange DSCSA-compliant electronic Product Identifier (PI) messages, trace products, and create an audit trail of their VRS business interactions.

CARO uses Self-Sovereign Identity (SSI) technology to establish a secure, verifiable digital enterprise identity for every ATP. By integrating the service into its VRS solution, rfxcel customers can ensure secure, authenticated data exchange with other ATPs and verify they have the credentials required by the DSCSA, including state licenses and U.S. Food and Drug Administration Entity Identifiers (FEIs).

“We partnered with Spherity to enable our customers to comply with this year’s DSCSA authorized trading partner (ATP) requirements,” said rfxcel Senior Vice President of Product and Strategy Herb Wong. “With Spherity’s CARO, our VRS solution automatically confirms whether a company is an ATP. Now, every customer can add ATP credentialing to our entire product portfolio and secure their VRS interactions.”

“Spherity will ensure that Antares Vision Group’s customers can securely exchange data with previously unknown entities,” said Georg Jürgens, Spherity’s Manager for Industry Solutions. “The concept of exchanging and verifying credentials using Digital Wallets supports company and product compliance use cases that require communication between regulators, existing supply chain partners, and new trading partners.”

Spherity and Antares Vision Group are members of the Open Credentialing Initiative (OCI), and both contribute to the standardization and industry-wide interoperability of credentialing technology.

For more information about the Spherity-Antares Vision Group partnership, their solutions for DSCSA compliance with ATP requirements, and the Open Credentialing Initiative, contact Spherity’s Manager for Industry Solutions Georg Jürgens at georg.juergens@spherity.com and visit caro.vc, and rfxcel Senior Vice President of Product and Strategy Herb Wong at hwong@rfxcel.com.

ABOUT ANTARES VISION GROUP

Antares Vision Group is an outstanding technology partner in digitalization and innovation for companies and institutions, guaranteeing the safety of products and people, business competitiveness, and environmental protection. The Group provides a unique and comprehensive ecosystem of technologies to guarantee product quality (inspection systems and equipment) and end-to-end product traceability (from raw materials to production, from distribution to the consumer) through integrated data management, applying artificial intelligence and blockchain technology. Antares Vision Group is active in life science (pharmaceutical, biomedical devices and hospitals) and Fast-Moving Consumer Goods (FMCG), including food, beverage, cosmetics, and glass and metal containers. As a world leader in track and trace solutions for pharmaceutical products, the Group provides major global manufacturers (over 50% of the top 20 multinationals) and numerous government authorities with solutions, monitoring their supply chains and validating product authenticity. Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from 14 May 2021 in the STAR segment of Euronext; furthermore, from July 2022 included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential. In 2022, Antares Vision Group recorded a turnover of €223.5 million. The Group operates in 60 countries, employs more than 1,100 people, and has a consolidated network of over 40 international partners. To learn more, please visit www.antaresvision.com and www.antaresvisiongroup.com.

ABOUT SPHERITY

Spherity is a German software provider bringing secure and decentralized identity management solutions to enterprises, machines, products, data and even algorithms. Spherity provides the enabling technology to digitalize and automate compliance processes in highly regulated technical sectors. Spherity’s products empower cybersecurity, efficiency and data interoperability among digital value chains. Spherity is certified according to the information security standard ISO 27001.

Is Ecstasy MDMA Addictive?

MDMA addiction

Clinical studies suggest that MDMA may increase the risk of long-term or permanent problems with memory and learning. Use of the drug becomes compulsive even when it causes harm, like experiencing poor health or losing relationships or jobs. There are differences between tolerance, dependence, and addiction to a drug. There are also powerful designer cathinone stimulants known by the street name “bath salts” that are often sold as molly. People taking these substitutes have strong cravings and much more violent reactions. However, a significant portion of what’s sold as molly is either mixed with other substances or contains no MDMA at all.

The Development of Addiction as a Result of Ecstasy Abuse

MDMA addiction

Our team does their best for our readers to help them stay informed about vital healthcare decisions. Addiction Resource does not offer medical diagnosis, treatment, or advice. Only trained and licensed medical professionals can provide such services.

What is MDMA?

There are ongoing clinical studies to test how well this treatment might work. Fentanyl can make drugs it’s mixed with, including MDMA, more dangerous. Often, people who purchase MDMA and other drugs are unaware those drugs have been cut with fentanyl. As the rave and club scene expanded to metropolitan and suburban areas across the country, MDMA use and distribution increased as well. Today, the drug is still used by a broader group of people who more commonly call it Ecstasy or Molly.

Addiction To Ecstasy And MDMA

Experts have called for more studies on MDMA’s lasting effects on the brain. Experts trace the creation of MDMA to the early 1900s, when it was manufactured for use as a medicinal compound. Starting in the 1970s, it was briefly explored for use in psychiatry. Around the same time, people began taking MDMA recreationally.

MDMA addiction

Physical, Mental, and Behavioral Effects of MDMA

MDMA addiction

Use is mostly in those between the ages of 18 and 25, with a lifetime prevalence of use of 10.5%. In many situations, it serves as a gateway drug due to the early onset of use. One of the effects that molly has on the body is increasing muscle activity. The user will not notice this due to the how long does mdma stay in body substance’s influence. This increased muscle activity produces heat, the body sweats profusely to counteract this, and the person may become dehydrated as a result.

MDMA addiction

Short-term side effects of MDMA

MDMA addiction

MDMA has many of the same physical effects as other stimulants such as cocaine and amphetamines. A person taking the drug will feel the effect within 1 hour, and it can last up to 6 hours. This page will discuss ecstasy withdrawal and addiction treatment. It’s important to spot the signs early if someone you know is struggling with ecstasy addiction. Other criteria for addiction include developing a tolerance to ecstasy, spending an extraordinary amount of time trying to get it, and using more of it than intended. Commonly abused at parties, ecstasy is popular among college students — especially at raves and concerts.

  • Along with these mental and physical effects of ecstasy, the drug also causes changes in how you see the world, such as not knowing what time it is or seeing things that are not there.
  • It also has some hallucinogenic properties similar to mescaline or peyote.
  • A treatment center will attempt to verify your health insurance benefits and/or necessary authorizations on your behalf.
  • AddictionResource fact-checks all the information before publishing and uses only credible and trusted sources when citing any medical data.
  • Pure MDMA is not considered as addictive as other illicit drugs such as cocaine, but some people can develop a dependence on the drug and have withdrawal symptoms when they stop using it.
  • Some people experience other negative effects for up to a week after taking MDMA; these include anxiety, irritability, sleep issues, and lower pleasure from and desire for sex.

Mostly known as a ‘party drug,’ MDMA may also have use in therapy for PSTD, anxiety, eating disorders, and more. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The DEA considers MDMA an illegal schedule I drug with no recognized medical uses. Damage to brain serotonin neurons can occur; serotonin is thought to play a role in regulating mood, memory, sleep, and appetite. Studies are conflicting on MDMA use and its affects on memory and cognition. It is also available as a powder and is sometimes snorted, taken as a liquid, and it is occasionally smoked but rarely injected.

How Common is Ecstasy Addiction?

Recognizing an addiction to ecstasy can be difficult because the drug lacks obvious withdrawal symptoms and is often used among young people in social settings. Regardless, continued use of ecstasy can lead to psychological and physical dependence. When someone is addicted to ecstasy, they will continue to use the drug despite knowing the consequences.

Understanding the Chemistry and Effects of MDMA

A qualified addiction professional can help you manage these symptoms and recover. Here’s some important information you need to know about molly. Stacia Murphy, former president of the National Council on Alcoholism and Drug Dependence, shares her story of recovery.

MDMA is being explored as a treatment for certain medical conditions, such as post-traumatic stress disorder (PTSD) and depression. Researchers are studying how drugs with psychedelic properties, including MDMA, can be used to treat mental health conditions. It was first synthesized in 1912 and was known as Methylsafrylaminc.

Dilutive Securities Example of How Dilution Impacts Share Prices

dilutive securities

Diluted EPS can provide a more accurate picture of a company’s financial condition than ordinary EPS. Since many companies have obligations that could result in additional shares being issued, it is best to express financial metrics such as EPS using a diluted share count. For example, suppose Company A has five existing shareholders, who each own 10% of the company.

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It refers to any action that helps an existing shareholder maintain or increase their voting power or receipt of the company’s EPS. If securities are retired, converted, or impacted by certain corporate activities, and the transaction results in an increased EPS, then the action is considered to be antidilutive. Weighted average anti-dilution provisions provide a more balanced approach to protecting investors from dilution. These provisions adjust the conversion price of convertible securities based on a weighted average formula that takes into account both the old and new shares and their respective prices. The adjustment ensures that the conversion price is lowered but not to the extent of the new issuance price. Beyond that, some other examples include convertible preferred shares, stock options, rights to buy, and convertible bonds.

To Ensure One Vote Per Person, Please Include the Following Info

Suppose the company then issues 10 new shares and a single investor buys them all. There are now 20 total shares outstanding and the new investor owns 50% of the company. Meanwhile, each original investor now owns just 5% of the company—one share out of 20 outstanding—because their ownership has been diluted by the new shares. Fully diluted EPS is important for investors, analysts, and companies to assess the impact of various securities on the company’s earnings per share.

Is there any other context you can provide?

For this reason, many public companies publish estimates of both non-diluted and diluted EPS, which is essentially a “what-if-scenario” for investors in the case new shares are issued. Diluted EPS assumes that potentially dilutive securities have already been converted to outstanding shares. When exercised, certain derivatives instruments are exchanged for shares of stock that are issued by the company to its employees.

dilutive securities

Ask Any Financial Question

All such information is provided solely for convenience purposes only and all users thereof should be guided accordingly. Finance Strategists has an advertising relationship with some of the companies included on this website. We may earn a commission when you click on a link or make a purchase through the links on our site. All of our content is based on objective analysis, and the opinions are our own. This could indicate that the company is not generating enough profits or that it has a higher potential for dilution.

Financial Statements and Diluted EPS

This can make it difficult to compare fully diluted EPS across companies in different countries or regions. A higher fully diluted EPS can lead to a higher P/E ratio, indicating that investors are willing to pay more for a company’s stock. Not all security mechanisms result in decreased EPS, and some even increase EPS. If securities are retired, converted or affected through certain corporate activities, and the transaction results in an increased EPS, then the action is considered to be anti-dilutive. Anti-dilution provisions are typically accounted for in financial statements by disclosing their existence and potential impact in the notes to the financial statements.

  • It is not adjusted for stock equivalents (such as options, warrants, and convertible securities).
  • Weighted average anti-dilution is a more moderate approach compared to full ratchet.
  • The formula for fully diluted EPS is (Net income – Preferred dividends) / (Outstanding shares + Conversion of dilutive securities).

These seus are then included in the calculation of eps until it is reduced to the smallest possible number. That is to say, the worst anti-dilutive unit will be entered into the calculation first. Despite this result, the anti-dilutive security should be included in the calculation of a fully diluted EPS. Note the 6,000 shares is the number that the firm could repurchase a cost which changes in proportion to changes in volume of activity is called after receiving $300,000 for the exercise of the options ([10,000 options x $30 exercise price] / $50 average market price). Share count would increase by 4,000 (10, ,000) because after the 6,000 shares are repurchased, there is still a 4,000 share shortfall that needs to be created. Shares can also be diluted by employees who have been granted stock options.

It is a risk that investors must be aware of as shareholders and they need to take a closer look at how dilution happens and how it can affect the value of their shares. Common stock is obviously the most common dilutive security because any additional issuances of common stock will automatically raise the number of outstanding shares. The corporation’s stock that has been approved and issued is known as the outstanding shares. Investors or institutions own the corporation through its outstanding shares. If all convertible securities of a corporation are exercised, all of these securities and extra shares are included in the fully diluted shares.

There also several financial ratios like the dilutive earnings per share that track the effect of these securities. When warrants are exercised, the number of outstanding shares increases, which can impact the fully diluted EPS calculation. If the company then has a secondary offering and issues 100 new shares to 100 more shareholders, each shareholder only owns 0.5% of the company. The smaller ownership percentage also diminishes each investor’s voting power. Share dilution may happen any time a company raises additional equity capital, as newly created shares are issued to new investors. The potential upside of raising capital in this way is that the funds the company receives from selling additional shares can improve the company’s profitability and growth prospects, and by extension the value of its stock.

The fundamental concern of existing shareholding after new securities are issued, or after securities are converted, is that their ownership interests are diminished as a result. It also becomes more difficult to determine the number of shares outstanding at a given time as more security types are introduced. Anti-dilution provisions are typically triggered when a company issues new shares at a price per share lower than the price paid by the existing investors for their convertible securities. You can also acquire warrants at a specific price and during a specified period/time.

India iVEDA Deadline Delayed for Track and Trace, Reporting

Our team in India just let us know that the iVEDA deadline for track and trace and reporting has been delayed. Here are the details.

As we wrote in early March, the Indian government had stipulated March 31 as the deadline for full track and trace and reporting to the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal. The rules were to apply to both small-scale industry (SSI)- and non-SSI-manufactured drugs.

Today, however, the government extended the iVEDA deadline to August 1, 2023. The announcement was made through Public Notice 3/2023, which was signed by signed by Director General of Foreign Trade Santosh Kumar Sarangi.

As of today, the August deadline for barcoding the Top 300 domestic pharma brands is still valid. This requires eight data points to be incorporated into a bar code or QR code, including a unique product identification code (e.g., GTIN), the brand name, and manufacturing and expiry dates. The codes must be printed on or affixed to the primary packaging.

Final thoughts about the iVEDA deadline and requirements

We will of course continue to monitor these regulations and post news when necessary. Bookmark our blog and check back often to make sure you’re keeping up to date. And contact us today if you have any questions about this delay or compliance in any other country where you do you business.

For a good overview of India’s pharma regulations, read our update from September 2022. If we may say, our “Final thoughts” section in that article was prescient. We wrote that “India’s track and trace requirements are obviously evolving” and the pharma industry should “expect more changes as the deadlines for APIs [active pharmaceutical ingredients], iVEDA reporting, and barcoding get nearer.”

That post also cited some statistics from India’s Department of Pharmaceuticals’ 2020-21 Annual Report. Check those out and compare them with the highlights from the 2021-2022 Annual Report below. India remains one of largest and most important pharma markets in the world — and we can help ensure you stay compliant as its regulations evolve.

India pharma stats, 2021-2022

• India provides generic medicines to more than 200 countries.
• India is home to 8 of the world’s 20 largest manufacturers of generic medicines.
• More than 55 percent of its pharma exports to go to “highly regulated markets.”
• Ninety percent of World Health Organization (WHO) pre-qualified APIs are sourced from India.
• Sixty-five to 70 percent of the WHO’s vaccine requirements are sourced from India.
• As of August 2021, there were 741 U.S. FDA-compliant manufacturing sites in India.
• As of December 2020, Indian companies had secured nearly 4,400 abbreviated new drug application (ANDA) market authorizations.