What were the key findings in the FDA’s final decision on Mepergan Fortis Capsules. How did the Administrative Law Judge rule on the drug’s effectiveness and status. Why did the FDA deem the applicant’s exceptions as withdrawn.

Background on Mepergan Fortis and FDA’s Review Process

Mepergan Fortis Capsules (MFC) contain a combination of meperidine HCl and promethazine HCl. The drug was subject to review under the FDA’s Drug Efficacy Study Implementation (DESI) program, which evaluated drugs approved as safe between 1938 and 1962 to determine their effectiveness.

In 1972, the FDA initially classified MFC as “possibly effective” for moderate to moderately severe pain. However, the agency stated that additional evidence was needed to establish the drug’s effectiveness. Subsequently, Wyeth submitted a supplemental new drug application (sNDA) for MFC.

The FDA’s Proposal to Refuse Approval and Hearing Process

In 1981, the FDA proposed to refuse approval of the sNDA for Mepergan Fortis Capsules. Wyeth requested a hearing, which was granted in 1984. An Administrative Law Judge (ALJ) conducted a hearing in 1986 and issued an Initial Decision in 1987.

Key Findings of the Administrative Law Judge

• The effectiveness of MFC had not been proven by substantial evidence from adequate and well-controlled clinical trials
• The requirements of the combination drug policy had not been met
• MFC is considered a “new drug” under 21 U.S.C. 321(p)

The Appeal Process and Final Decision

Wyeth filed exceptions to the ALJ’s Initial Decision, effectively appealing the ruling. However, recent developments have led to a significant change in the status of this appeal.

How did the FDA proceed with the appeal? The FDA requested that the current owner of the sNDA application affirm its desire to pursue the appeal of the ALJ’s Initial Decision. When the applicant failed to affirm within the specified timeframe, the FDA deemed the exceptions as withdrawn.

What is the consequence of this withdrawal? As a result, the proceeding is in the same procedural position as if no exceptions to the ALJ’s Initial Decision had been filed. This means that the ALJ’s Initial Decision has become the final decision of the Commissioner by operation of law.

Implications of the Final Decision on Mepergan Fortis

The FDA’s final decision has significant implications for Mepergan Fortis Capsules. What does this mean for the drug’s status?

1. Effectiveness not established: MFC has not been shown to be supported by substantial evidence consisting of adequate and well-controlled studies for its intended use.
2. Combination drug policy: The drug did not satisfy the FDA’s combination drug policy requirements.
3. New drug status: MFC is officially classified as a “new drug” under FDA regulations.

These findings effectively mean that the FDA has refused approval of the supplemental new drug application for Mepergan Fortis Capsules.

Understanding the FDA’s Combination Drug Policy

The FDA’s combination drug policy plays a crucial role in the evaluation of drugs like Mepergan Fortis Capsules. What are the key aspects of this policy?

• Rationale: Each component of a combination drug must contribute to the claimed effects.
• Evidence: Manufacturers must provide evidence that the combination is safe and more effective than each component used individually.
• Benefit-risk assessment: The benefits of the combination must outweigh the risks associated with its use.

In the case of Mepergan Fortis, the ALJ determined that the drug did not meet these requirements, contributing to the decision to refuse approval.

The Significance of “New Drug” Classification

The classification of Mepergan Fortis Capsules as a “new drug” under 21 U.S.C. 321(p) has important regulatory implications. What does this classification mean?

A “new drug” is defined as a drug that is not generally recognized as safe and effective for its intended use. This classification requires the manufacturer to submit a new drug application (NDA) and obtain FDA approval before marketing the drug.

For Mepergan Fortis, this classification reinforces the need for substantial evidence of safety and efficacy through well-controlled studies before it can be approved for market.

The Role of Substantial Evidence in Drug Approval

The FDA’s decision heavily emphasizes the lack of substantial evidence supporting Mepergan Fortis Capsules’ effectiveness. What constitutes substantial evidence in the context of drug approval?

• Adequate and well-controlled studies: Clinical trials that are designed and conducted according to scientific standards.
• Reproducibility: Results that can be consistently replicated across multiple studies.
• Statistical significance: Data that demonstrates a clear therapeutic effect beyond what could occur by chance.
• Clinical relevance: Evidence that the drug’s effects are meaningful in real-world patient care.

The ALJ’s finding that MFC lacked this level of evidence was a critical factor in the decision to refuse approval.

Implications for Patient Care and Drug Development

The FDA’s final decision on Mepergan Fortis Capsules has broader implications for both patient care and the pharmaceutical industry. How might this decision impact these areas?

For patient care:

• Ensures that only drugs with proven safety and efficacy are available for use
• Protects patients from potentially ineffective or unsafe combination medications
• May limit treatment options for certain conditions, necessitating alternative therapies

For drug development:

• Reinforces the importance of rigorous clinical trials and evidence-based approaches
• Highlights the challenges in developing and gaining approval for combination drugs
• May influence future research and development strategies in pain management

This decision underscores the FDA’s commitment to maintaining high standards for drug approval, even for medications that have been in use for many years.

The Future of Pain Management and Combination Drugs

Given the FDA’s decision on Mepergan Fortis Capsules, what might the future hold for pain management and the development of combination drugs?

Potential trends and considerations:

1. Increased focus on novel, single-agent pain medications
2. More rigorous testing of combination drugs to meet FDA standards
3. Exploration of alternative pain management strategies, including non-pharmacological approaches
4. Greater emphasis on personalized medicine to optimize pain treatment
5. Continued evaluation of older combination drugs to ensure they meet current efficacy and safety standards

The pharmaceutical industry may need to adapt its research and development strategies to address these challenges and opportunities in pain management.

Lessons Learned from the Mepergan Fortis Case

The Mepergan Fortis case offers valuable insights for drug manufacturers, healthcare providers, and regulatory bodies. What are some key takeaways from this prolonged regulatory process?

• Importance of robust clinical evidence: The case underscores the critical need for well-designed, adequately powered clinical trials to support drug efficacy claims.
• Evolving regulatory standards: Drugs approved in the past may not meet current regulatory requirements, necessitating ongoing evaluation and potential market withdrawal.
• Complexity of combination drugs: Developing and gaining approval for combination medications presents unique challenges that require careful consideration and planning.
• Long-term regulatory processes: The timeline of this case, spanning several decades, highlights the potential for prolonged regulatory proceedings in complex cases.
• Importance of active engagement: The outcome of this case was influenced by the current owner’s failure to affirm their desire to pursue the appeal, emphasizing the need for ongoing communication with regulatory authorities.

These lessons can inform future drug development efforts and regulatory strategies across the pharmaceutical industry.

The Role of Post-Marketing Surveillance in Drug Safety

While the Mepergan Fortis case primarily focused on efficacy, it also raises questions about the ongoing evaluation of drug safety. How does post-marketing surveillance contribute to drug safety assessments?

Post-marketing surveillance involves:

• Monitoring adverse event reports from healthcare providers and patients
• Conducting large-scale observational studies to detect rare or long-term side effects
• Evaluating real-world effectiveness data
• Reassessing the benefit-risk profile of drugs as new information becomes available

This ongoing process allows regulatory agencies to identify potential safety concerns that may not have been apparent during initial clinical trials. In cases like Mepergan Fortis, where the drug has been in use for an extended period, post-marketing data can provide valuable insights into its long-term safety profile.

The Impact of Regulatory Decisions on Healthcare Practice

The FDA’s decision on Mepergan Fortis Capsules may have ripple effects throughout the healthcare system. How might this regulatory action influence clinical practice?

Potential impacts include:

1. Reassessment of pain management protocols: Healthcare providers may need to review and update their pain management strategies, particularly for patients who may have been using Mepergan Fortis.
2. Increased scrutiny of other combination drugs: Clinicians may be more cautious about prescribing other combination medications, especially those approved before current efficacy standards were established.
3. Enhanced focus on evidence-based medicine: The case reinforces the importance of basing clinical decisions on robust scientific evidence.
4. Challenges in managing patient expectations: Healthcare providers may need to educate patients about the reasons for changing long-standing medication regimens.
5. Potential for increased off-label use: In the absence of approved combination drugs, there may be a temptation to prescribe individual components separately, potentially leading to off-label use scenarios.

Healthcare professionals will need to stay informed about regulatory decisions and their implications for patient care, adapting their practices accordingly.

The Future of Drug Regulation and Approval Processes

The Mepergan Fortis case provides a glimpse into the complexities of drug regulation. What trends might we see in future drug approval processes?

Potential developments in drug regulation:

• Increased use of real-world evidence: Regulatory agencies may incorporate more real-world data into their decision-making processes, complementing traditional clinical trial results.
• Adaptive clinical trial designs: More flexible trial designs that allow for modifications based on interim results may become more common, potentially streamlining the approval process for some drugs.
• Enhanced focus on patient-reported outcomes: Greater emphasis may be placed on how drugs impact patients’ quality of life and functional status, not just clinical endpoints.
• Accelerated approval pathways: For drugs addressing unmet medical needs, regulators may continue to refine processes for faster initial approval with requirements for post-market confirmation of benefits.
• Increased international harmonization: Efforts to align regulatory requirements across different countries may intensify, potentially simplifying the global drug development and approval process.

These trends could shape the future landscape of drug development and regulation, influencing how new therapies reach patients in need.

Ethical Considerations in Drug Approval and Withdrawal

The Mepergan Fortis case raises important ethical questions about drug approval and withdrawal. What are some of the key ethical considerations in these processes?

Ethical dimensions to consider:

1. Balancing innovation and safety: How can regulators encourage pharmaceutical innovation while ensuring patient safety?
2. Equity in access to medications: How do regulatory decisions impact different patient populations, particularly those with limited treatment options?
3. Transparency in decision-making: What level of transparency should be required in regulatory processes and decisions?
4. Managing conflicts of interest: How can the influence of financial interests on drug development and approval be appropriately managed?
5. Responsibility to patients using withdrawn drugs: What obligations do manufacturers and healthcare systems have to patients who have been using drugs that are subsequently withdrawn or not approved?

Addressing these ethical considerations is crucial for maintaining public trust in the drug approval process and ensuring that regulatory decisions serve the best interests of patients and public health.

The Role of Patient Advocacy in Drug Regulation

Patient advocacy groups play an increasingly important role in drug development and regulation. How might patient perspectives influence cases like that of Mepergan Fortis?

Potential impacts of patient advocacy:

• Bringing attention to unmet medical needs
• Providing real-world insights into the benefits and risks of medications
• Influencing research priorities and clinical trial designs
• Advocating for continued access to medications under review
• Participating in FDA advisory committee meetings and public hearings

While scientific evidence remains the cornerstone of regulatory decisions, patient perspectives can provide valuable context and highlight the real-world implications of these decisions. Balancing these perspectives with rigorous scientific standards is an ongoing challenge for regulatory agencies.

Implications for Global Pharmaceutical Markets

Regulatory decisions in one country can have far-reaching effects on global pharmaceutical markets. How might the FDA’s decision on Mepergan Fortis impact international drug development and marketing?

Potential global implications:

1. Reassessment of similar products in other markets: Regulatory agencies in other countries may review their own approvals of similar combination drugs.
2. Harmonization of standards: The case may contribute to efforts to align drug approval standards across different regulatory jurisdictions.
3. Impact on international clinical trial designs: Pharmaceutical companies may adjust their global clinical trial strategies to ensure they meet the most stringent regulatory requirements.
4. Market access challenges: Companies may face increased scrutiny when seeking approval for combination drugs in multiple markets.
5. Potential for regulatory arbitrage: Differences in regulatory decisions across countries could lead to situations where drugs are available in some markets but not others.

These global implications underscore the interconnected nature of pharmaceutical regulation and the importance of international cooperation in ensuring drug safety and efficacy worldwide.

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 | Participant of the Skolkovo project

LIMITED LIABILITY COMPANY “FORTIS”

Primary activity (OKVED)

62.01 –

Development of computer software

90 002

About the company

Fortis company (part of the GC MONOPOLY) 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)

Primary 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 32

Contact company 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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