What is Mepergan Fortis. What were the key findings in the FDA’s final decision. How does this impact the drug’s approval status. What is the significance of the Drug Efficacy Study Implementation program. What were the main issues with Mepergan Fortis’s effectiveness data.

Understanding Mepergan Fortis: Composition and Proposed Use

Mepergan Fortis Capsules (MFC) is a combination drug containing meperidine hydrochloride and promethazine hydrochloride. It was proposed for use in sedation and analgesia for patients experiencing concurrent moderate pain and apprehension, such as those in postoperative or post-trauma situations.

Key Components of Mepergan Fortis

• Meperidine hydrochloride: An opioid pain medication
• Promethazine hydrochloride: An antihistamine with sedative properties

The combination of these two active ingredients was intended to provide both pain relief and anxiety reduction for patients in specific clinical scenarios. However, the effectiveness and safety of this combination became a subject of scrutiny by the Food and Drug Administration (FDA).

The FDA’s Final Decision on Mepergan Fortis

The FDA has announced that the Initial Decision of the Administrative Law Judge (ALJ) to refuse approval of the supplemental new drug application (sNDA) for Mepergan Fortis Capsules has become the final decision of the Commissioner by operation of law. This decision marks a significant milestone in the regulatory journey of MFC.

Key Findings in the ALJ’s Initial Decision

1. Lack of substantial evidence: MFC had not been shown to be effective for its proposed use through adequate and well-controlled studies.
2. Failure to satisfy combination drug policy: The drug did not meet the requirements set forth for combination medications.
3. Classification as a “new drug”: MFC was determined to fall under the category of a new drug under 21 U.S.C. 321(p).

These findings collectively led to the refusal of approval for the sNDA. The applicant initially filed exceptions to the ALJ’s Initial Decision but later failed to affirm their desire to pursue the appeal within the specified timeframe, resulting in the withdrawal of those exceptions.

The Drug Efficacy Study Implementation (DESI) Program

The Drug Efficacy Study Implementation (DESI) program plays a crucial role in the context of Mepergan Fortis and other pre-1962 drugs. This program was initiated following the 1962 amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Purpose and Scope of DESI

• Evaluate drugs approved as safe between 1938 and 1962
• Determine the effectiveness of these drugs
• Withdraw approval for any new drug application lacking substantial evidence of effectiveness

Under the DESI program, the burden of providing evidence of effectiveness falls on the party contesting the withdrawal of approval. This process ensures that older drugs meet modern standards of safety and efficacy.

Mepergan Fortis: Timeline of Regulatory Actions

The regulatory history of Mepergan Fortis spans several decades, involving multiple evaluations and decisions by the FDA. Understanding this timeline provides insight into the complex process of drug approval and review.

Key Dates in Mepergan Fortis’s Regulatory Journey

• April 20, 1972: FDA classifies MFC as “possibly effective” for moderate to moderately severe pain
• September 18, 1981: Director of the Bureau of Drugs proposes to refuse approval of the sNDA
• December 31, 1984: Office of the Commissioner grants a hearing request
• January 14-17, 1986: ALJ conducts a hearing
• December 4, 1987: ALJ issues Initial Decision
• November 16, 2017: Final decision becomes effective

This extended timeline reflects the thorough and deliberate nature of the FDA’s review process, especially for drugs with complex histories like Mepergan Fortis.

Effectiveness Concerns: The Crux of the FDA’s Decision

The primary issue leading to the refusal of approval for Mepergan Fortis was the lack of substantial evidence demonstrating its effectiveness. This highlights the FDA’s commitment to ensuring that approved drugs meet rigorous scientific standards.

What constitutes substantial evidence of effectiveness?

Substantial evidence typically consists of adequate and well-controlled studies that demonstrate a drug’s efficacy for its intended use. In the case of Mepergan Fortis, the FDA determined that such evidence was lacking.

Challenges in Proving Effectiveness

• Lack of adequate and well-controlled clinical trials
• Insufficient data on the drug’s performance in its target patient population
• Failure to meet modern standards for drug efficacy evaluation

These challenges underscore the importance of robust clinical research in the drug approval process and the evolving nature of regulatory standards over time.

Combination Drug Policy: Another Hurdle for Mepergan Fortis

The FDA’s combination drug policy is designed to ensure that each component of a combination drug contributes to its overall effectiveness and safety. Mepergan Fortis, as a combination of meperidine and promethazine, failed to satisfy this policy.

Requirements of the Combination Drug Policy

• Each active ingredient must contribute to the claimed effects
• The combination must be safe and effective for a significant patient population
• The combination must provide a benefit that outweighs the risks of using multiple active ingredients

The failure to meet these requirements suggests that the combination of meperidine and promethazine in Mepergan Fortis did not demonstrate a clear advantage over individual components or alternative treatments.

Implications of Mepergan Fortis’s Classification as a “New Drug”

The ALJ’s decision to classify Mepergan Fortis as a “new drug” under 21 U.S.C. 321(p) has significant regulatory implications. This classification subjects the drug to more stringent approval requirements.

What does “new drug” classification mean?

A “new drug” designation typically applies to drugs that are not generally recognized as safe and effective for their intended use. This classification requires the submission of a new drug application (NDA) with comprehensive data on safety and efficacy before marketing approval can be granted.

Consequences of “New Drug” Status

• Requirement for extensive clinical trials
• More rigorous review process by the FDA
• Potential need for additional safety and efficacy data

For Mepergan Fortis, this classification further complicated its path to approval, necessitating a higher standard of evidence to support its use.

The Appeal Process and Its Outcome

Following the ALJ’s Initial Decision, the sNDA applicant had the opportunity to appeal. However, the appeal process for Mepergan Fortis took an unexpected turn.

Initial Appeal and Subsequent Developments

• The applicant initially filed exceptions to the ALJ’s Initial Decision
• FDA requested confirmation of the applicant’s desire to pursue the appeal
• The applicant failed to affirm their intention within the specified timeframe

As a result of the applicant’s inaction, the FDA deemed the exceptions withdrawn. This procedural development effectively ended the appeal process, leaving the ALJ’s Initial Decision to stand as the final decision of the Commissioner.

Significance of the Appeal Outcome

The withdrawal of the appeal highlights the importance of active engagement in the regulatory process. It also demonstrates how procedural aspects can significantly impact the final outcome of drug approval decisions.

Broader Implications for the Pharmaceutical Industry

The case of Mepergan Fortis offers valuable insights into the FDA’s drug approval process and its evolving standards for safety and efficacy. It serves as a cautionary tale for pharmaceutical companies developing new drugs or seeking approval for older formulations.

Lessons for Drug Developers

• The importance of robust clinical trial data
• The need to meet contemporary standards for drug efficacy and safety
• The challenges of gaining approval for combination drugs
• The significance of actively engaging with regulatory authorities throughout the approval process

These lessons underscore the rigorous nature of the FDA’s approval process and the high standards that must be met to bring a drug to market.

The Future of Pain Management and Sedation

The rejection of Mepergan Fortis raises questions about the future direction of pain management and sedation therapies, particularly for postoperative and post-trauma patients.

Emerging Trends in Pain Management

• Focus on non-opioid alternatives
• Development of targeted therapies with fewer side effects
• Exploration of multimodal pain management approaches
• Increased scrutiny of combination drugs in pain management

As the medical community continues to grapple with the challenges of pain management, the FDA’s decision on Mepergan Fortis may influence future drug development strategies and regulatory approaches in this field.

Regulatory Transparency and Public Health

The FDA’s handling of the Mepergan Fortis case demonstrates the agency’s commitment to transparency in its decision-making processes. By making the final decision publicly available, the FDA provides valuable insights into its regulatory standards and decision-making criteria.

Benefits of Regulatory Transparency

• Enhances public trust in the drug approval process
• Provides guidance for pharmaceutical companies in drug development
• Allows healthcare providers to make informed decisions about treatment options
• Promotes accountability in the pharmaceutical industry

This transparency serves the broader goal of protecting public health by ensuring that only safe and effective drugs reach the market.

The Role of Administrative Law in Drug Regulation

The Mepergan Fortis case highlights the significant role that administrative law plays in the regulation of pharmaceuticals. The involvement of an Administrative Law Judge and the formal hearing process demonstrate the legal complexities involved in drug approval decisions.

Key Aspects of Administrative Law in Drug Regulation

• Provides a structured process for resolving disputes between regulatory agencies and drug manufacturers
• Ensures due process in regulatory decision-making
• Allows for expert testimony and evidence presentation
• Creates a record of proceedings for potential future review

Understanding these legal aspects is crucial for both regulators and pharmaceutical companies navigating the complex landscape of drug approval and regulation.

The Impact on Patient Care and Treatment Options

The FDA’s decision on Mepergan Fortis has direct implications for patient care, particularly in the areas of pain management and sedation for postoperative and post-trauma patients.

Considerations for Healthcare Providers

• Need to reassess treatment protocols that may have included Mepergan Fortis
• Importance of staying informed about FDA decisions on drug approvals and withdrawals
• Opportunity to explore alternative treatment options for pain and anxiety management
• Potential for increased focus on individualized treatment approaches

Healthcare providers must navigate these changes while ensuring optimal patient care and staying compliant with regulatory standards.

The Evolving Landscape of Drug Safety and Efficacy Standards

The Mepergan Fortis case serves as a testament to the evolving nature of drug safety and efficacy standards. As scientific knowledge advances and regulatory frameworks adapt, the criteria for drug approval continue to become more stringent.

Factors Driving Changes in Drug Approval Standards

• Advancements in medical research and technology
• Increased understanding of drug interactions and long-term effects
• Growing emphasis on evidence-based medicine
• Heightened public awareness and expectations for drug safety

These evolving standards challenge pharmaceutical companies to continually improve their research and development processes to meet regulatory requirements.

Ethical Considerations in Drug Development and Approval

The case of Mepergan Fortis raises important ethical questions about drug development, testing, and approval processes. It highlights the delicate balance between innovation in healthcare and ensuring patient safety.

Ethical Dilemmas in Pharmaceutical Research

• Balancing the need for new treatments with potential risks to patients
• Ensuring transparency in clinical trial data and results
• Addressing conflicts of interest in drug development and approval processes
• Considering the societal impact of drug approvals and withdrawals

These ethical considerations play a crucial role in shaping regulatory decisions and public trust in the pharmaceutical industry.

The Global Context: International Implications of FDA Decisions

While the FDA’s decision on Mepergan Fortis is specific to the United States, it has potential implications for drug regulation and approval processes worldwide. Many countries look to FDA decisions as benchmarks for their own regulatory frameworks.

International Repercussions of FDA Rulings

• Influence on drug approval processes in other countries
• Potential impact on global pharmaceutical market trends
• Opportunities for international collaboration in drug safety and efficacy standards
• Challenges in harmonizing regulatory approaches across different jurisdictions

Understanding these global implications is crucial for pharmaceutical companies operating in an increasingly interconnected world market.

Future Directions in Regulatory Science and Drug Approval

The Mepergan Fortis case provides insights into potential future directions for regulatory science and drug approval processes. It highlights areas where improvements and innovations may be needed to ensure more efficient and effective drug evaluation.

Potential Advancements in Drug Regulation

• Implementation of advanced data analytics in drug efficacy assessment
• Development of more sophisticated models for predicting drug interactions and side effects
• Increased use of real-world evidence in regulatory decision-making
• Exploration of adaptive clinical trial designs to streamline the approval process

These advancements could lead to more targeted and efficient drug development processes, potentially benefiting both patients and the pharmaceutical industry.

Mepergan Fortis Capsules; Final Decision on Proposal To Refuse Approval of Supplemental New Drug Application; Availability of Final Decision

Start Preamble

Food and Drug Administration; HHS.

Notice.

The Food and Drug Administration (FDA or the Agency) is announcing that the Initial Decision of the Administrative Law Judge (ALJ), to refuse approval of the supplemental new drug application (sNDA) for Mepergan Fortis Capsules (MFC) (meperidine HCl, promethazine HCl), is the final decision of the Commissioner by operation of law. In the Initial Decision, the ALJ found that MFC had not been shown to be supported by substantial evidence consisting of adequate and well-controlled studies to be effective for sedation and analgesia in patients with concurrent moderate pain and apprehension, such as postoperative and post-trauma patients with those symptoms; that the drug did not satisfy the combination drug policy; and that it is a “new drug. ” The sNDA applicant filed exceptions to the ALJ’s Initial Decision. FDA recently requested that the current owner of the sNDA application affirm its desire to pursue the appeal of the ALJ’s Initial Decision; however, the applicant did not affirm its desire to pursue the appeal within the specified timeframe. Accordingly, FDA now deems those exceptions as withdrawn. Consequently, the proceeding is in the same procedural position as if no exceptions to the ALJ’s Initial Decision had been filed; therefore, the ALJ’s Initial Decision has become the final decision of the Commissioner by operation of law.

This final decision is effective November 16, 2017.

For access to the docket, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 between 9 a. m. and 4 p.m., Monday through Friday. Publicly available submissions may be seen in the docket.

Start Further Info

Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.

End Further Info
End Preamble
Start Supplemental Information

I. Background

In 1962, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) was amended by the Drug Amendments Act of 1962, and these amendments provided that new drugs could no longer be approved unless both safety and efficacy had been established for them. As amended, the FD&C Act also required FDA to evaluate drugs approved as safe between 1938 and 1962 to determine whether such drugs were effective and to withdraw approval for any new drug application (NDA) where there was not substantial evidence of the drug’s effectiveness. The person contesting the withdrawal of the approval had the burden of coming forward with evidence of effectiveness for the drug. FDA’s review of these pre-1962 drugs is known as the Drug Efficacy Study Implementation (DESI) program.

In a document published in the Federal Register of April 20, 1972 (37 FR 7827), after evaluating reports received from the National Academy of Sciences/National Research Council, Drug Efficacy Study Group, and other available evidence, FDA classified MFC as “possibly effective” for moderate to moderately severe pain. This document also stated that no NDA had been approved or deemed approved for MFC and that additional evidence needed to be submitted to FDA to establish MFC’s effectiveness. Thereafter, Wyeth, a division of American Home Products (Wyeth), submitted a supplement to its approved NDA 11-730 (Mepergan Injection) for MFC (NDA 11-730, S-003). In a document published in the Federal Register of September 18, 1981 (46 FR 46404), the Director of the Bureau of Drugs (now the Center for Drug Evaluation and Research) proposed to refuse approval of the sNDA and offered Wyeth the opportunity for a hearing.

Wyeth submitted its request for a hearing and, by a document published in the Federal Register of December 31, 1984 (49 FR 50788), the Office of the Commissioner granted the hearing request. Following the submission of written testimony and documentary evidence, an ALJ, Daniel J. Davidson, conducted a hearing from January 14 to 17, 1986. He issued his Initial Decision on December 4, 1987. The ALJ found that: (1) The effectiveness of MFC had not been proven by substantial evidence of adequate and well-controlled clinical trials, (2) the requirements of the combination drug policy had not been met, and (3) MFC is a new drug under 21 U.S.C. 321(p). Wyeth timely appealed the ALJ’s Initial Decision by filing exceptions with the Commissioner under 21 CFR 12.125.

On August 23, 2017, FDA sent a letter to West-Ward Pharmaceuticals Corporation (West-Ward), successor to Wyeth, to determine whether West-Ward remained interested in pursuing its appeal of the ALJ’s Initial Decision. FDA informed the company that if it did not respond and affirm its desire to pursue its appeal by September 21, 2017, the Office of the Commissioner would conclude that West-Ward no longer wishes to pursue the appeal of the ALJ’s Initial Decision and will proceed as if the appeal has been withdrawn. The Office of the Commissioner did not receive a response from West-Ward by the given date; therefore, the Commissioner now deems the exceptions withdrawn.

II. Conclusion and Order

Given that the exceptions have been deemed withdrawn, this proceeding is now in the same procedural posture as if no exceptions had ever been filed. When parties do not file exceptions to the ALJ’s Initial Decision, and the Commissioner does not file a notice of review, the ALJ’s Initial Decision becomes the final decision of the Commissioner (see 21 CFR 12.120(e)). FDA will publish a notice in the Federal Register when an initial decision becomes the final decision of the Commissioner without appeal to or review by the Commissioner (see 21 CFR 12. 120(f)).

Therefore, the ALJ’s Initial Decision is the final decision of the Commissioner effective November 16, 2017. Pursuant to the findings in the ALJ’s Initial Decision, under section 505(d) of the FD&C Act (21 U.S.C. 355(d)) and under the authority delegated by the Secretary of Health and Human Services, the Commissioner finds that there is a lack of substantial evidence that MFC will have the effect it purports or is represented to have under the conditions of use prescribed, Start Printed Page 53508recommended, or suggested in its labeling for sedation and analgesia in patients with concurrent moderate pain and apprehension, such as postoperative and post-trauma patients with those symptoms. The Commissioner further finds that MFC does not meet the combination drug policy in 21 CFR 300.50 and that it is a “new drug” within the meaning of 21 U.S.C. 321(p). Therefore, approval of the sNDA for MFC is denied. Distribution of products subject to the ALJ’s Initial Decision in interstate commerce without an approved application is prohibited and subject to regulatory action (see, e. g., sections 505(a) and 301(d) (21 U.S.C. 331(d)) of the FD&C Act).

The full text of the ALJ’s Initial Decision may be seen in the Dockets Management Staff and in this docket (see ADDRESSES).

Start Signature

End Signature
End Supplemental Information

[FR Doc. 2017-24806 Filed 11-15-17; 8:45 am]

BILLING CODE 4164-01-P

Memorable misfills of a retail pharmacist

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000″>Apr 16, 2007

Every pharmacist has his own horror stories that are seared into his brain. Here are some that stand out in my mind.

1. Mepergan Fortis/cephalexin: A pharmacist told me this story. She discovered that she had dispensed Mepergan Fortis (meperidine/promethazine, Wyeth) (a powerful narcotic pain reliever) instead of cephalexin 500 mg (an antibiotic). It’s easy to see how this error occurred. Both are dark red capsules. She called her husband and told him to go to the customer’s house to retrieve the Mepergan Fortis. She cried into the phone to her husband: “GO GET IT! GO GET IT!” Her voice broke as she told me the story.

5. Carbamazepine/theophylline: A local doctor told me that one of his patients was in his office “and he’s dying.” The doctor proceeded to tell me that we had dispensed carbamazepine (which treats seizures) rather than theophylline (which treats asthma). We had dispensed the drugs in the manufacturer’s original container, so the doctor knew the contents from the exposed label. After I listened to the doctor’s tirade, I asked, “Are you serious that he’s dying?” The doctor said, “No, but he’s pretty damned mad. His asthma has been out of control for a week.” I finally asked the doctor the question that was uppermost on my mind: “Which pharmacist’s name is on the bottle?” It turned out to be my partner’s name. I told the doctor that I was not responsible for the error, so he backed off. I found out later that my partner was indeed sued.

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Fortis – equipment for rehabilitation

Medical rehabilitation is carried out on the basis of past illnesses or for the treatment of chronic pathologies. The complex of measures is designed to restore the physiological functions of the human body, return the patient to a full life, social and labor. In the totality of procedures of a different nature, much attention is paid to physiotherapy and physiotherapy exercises, which are carried out with the help of special technical devices – rehabilitation equipment.

Our products

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Offer to purchase:

• Rehabilitation equipment for the musculoskeletal system
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• Trainers

In the development of all devices, the achievements of scientific and technological progress are introduced. Devices are used outside the acute phase of pathology for regular effects on the body or individual systems. The high efficiency of the use of equipment for the purpose of habilitation, that is, to control the quality of physical activity, to teach the correct operation of the “mental tension / relaxation” systems (alpha, beta training), and to increase the adaptive capabilities of the body, has been proven. Equipment for rehabilitation and physiotherapy is used to prevent diseases, treat chronic disorders, accelerate recovery after surgery, injuries.

Buy rehabilitation equipment

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In order not to make a mistake in choosing rehabilitation equipment for the home and buy the right option, you need to consult a rehabilitation doctor or our specialists. December 03, 2018
From December 3 to December 7, 2018 in Moscow, at the Expocentre Central Exhibition Complex, the international scientific and practical Forum “Russian Health Care Week” will be held – the largest exhibition and congress event in Russia in the field of healthcare, the country’s largest review of achievements in scientific and practical medicine. The central event of the forum is the 28th international exhibition “Healthcare-2018”.

October 04, 2018

VIII International Scientific and Practical Conference “Kaishibaev Readings”, dedicated to the 10th anniversary of the NGO “League of Neurologists – Scientific and Practical Center “Institute of Neurology named after Smagul Kaishibaev”

Dear colleagues! We invite you to visit V III International Scientific practical conference “Kaishibaev Readings”, which will be held on October 4, 5, 2018 in the Reception House at the address: Almaty, Kurmangazy st. , 44.

FORTIS | Participant of the Skolkovo project

LIMITED LIABILITY COMPANY “FORTIS”

Primary activity (OKVED)

62.01 –

Development of computer software

About the company

The company “Fortis” (part of the MONOPOLY Group) develops scalable logistics services for the market of moving goods by road. The main product of the company is the high-tech web platform Monopoly.online, which hosts services for solving transport logistics problems. The company strives to solve the problem of digital disruption of the logistics industry, build a real holistic ecosystem for transport companies, retailers and manufacturers of goods, implement a full-fledged sharing economy and aggregation of resources participating in the industry. To solve these problems, the company has united in one place the best IT specialists of the country with relevant competencies and extensive experience in building an effective transport business for the MONOPOLY company. The company employs 167 employees. General Director: Mikhailova Ekaterina Vladimirovna. Founders: Monopoly JSC (

The company operates in the regions

St. Petersburg

Company maturity assessment

6

CRL (company readiness level)

8

IRL (investment readiness level)

Main activity (OKVED)

62.01 –

Computer software development

Projects

Business model

Business to Business to Consumer (B2B2C) Business to Business (B2B)

Project maturity assessment

9

TRL (Technology readiness level)

9

MRL (Market readiness level)

9 0002 Description of the project

ensuring the process of cargo transportation.
The solution is a digital platform that combines all the services necessary for organizing cargo transportation, from cargo search to cardless fuel processing and services from a network of proven road complexes throughout Russia.
The main functionality has been implemented: searching for cargo, paying for fuel and services of road complexes, receiving payments for transportation.
The immediate goals are to close the entire customer path of the cargo carrier into an ecosystem of products.

Products

Product Description

Multiservice
MONOPOLY.MULTISERVICE
MONOPOLY.Multiservice
Monocard

Register of Russian programs for electronic computers and databases

https://reestr.digital.gov.ru/reestr/1445121/

URL of the copyright holder’s website with information

https://multiservice99.monopoly.su /

Product type

Software

Product description

The digital logistics platform monopoly.online combines the services necessary for the organization of cargo transportation: search for cargo and carriers, payment for fuel and roadside services. The platform is designed for the efficient organization of cargo transportation, at the moment the platform provides the possibility of agreeing on an application for the transportation of goods, creating a convenient route for cargo transportation, searching for cargo taking into account the needs of the cargo carrier, and more.

Product maturity assessment

8

TRL (Technology readiness level)

9

MRL (Market readiness level)

Project team

262 people

Revenue

368 112 000 ₽

Volume of attracted investments

425 800 000 ₽

Rates growth

901 82

Contact now

Analytics

0002 Financial indicators

Balance sheet

Taxes

Headcount

Intellectual property

Company Information

Founders

JOINT STOCK COMPANY “MONOPOLIA”

100%

MONOPOLY

0%

Share capital

10,000 ₽

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