Applications
The application registry is the operational core of the Regulatory Information Management system. Each application represents a formal regulatory submission to a competent authority for a specific product and market, tracked from initial filing through approval, renewals, and post-approval lifecycle.
FailedActiveCompletedPendingBlockedApprovedSubmittedIn ProgressDraftOverdueTotal: 100
| Application # | Product | Market | Authority | Procedure Type | Status | Owner | Submitted | Approved |
|---|---|---|---|---|---|---|---|---|
| FDA-2024-0001 | Ocluvance | US | FDA | Type II Variation | Failed | Carlos Mendez | 2022-09-18 | 2023-01-04 |
| EMA-2023-0002 | Verasol | EU | EMA | Type IA Variation | Approved | James O'Brien | 2024-05-26 | — |
| PMDA-2022-0003 | Cardivex | JP | PMDA | Type IB Variation | Approved | Carlos Mendez | 2023-10-25 | 2024-05-20 |
| NMPA-2021-0004 | Nepricor | CN | NMPA | MAA | Approved | Nadia Petrova | 2023-07-05 | 2023-04-15 |
| ANVISA-2020-0005 | Immuvance | BR | ANVISA | Type IB Variation | Active | Sarah Chen | 2024-02-05 | — |
| HC-2024-0006 | Duplexan | CA | HC | sNDA | Active | Priya Sharma | 2022-05-08 | — |
| TGA-2023-0007 | Neuraclair | AU | TGA | Label Update | Submitted | Lieselotte van der Berg | 2022-11-07 | 2023-08-02 |
| MHRA-2022-0008 | Alzaclear | GB | MHRA | sMAA | Draft | James O'Brien | 2022-08-05 | 2024-09-09 |
| SwissMedic-2021-0009 | Raredex | CH | SwissMedic | MAA | In Progress | Marcus Webb | 2022-06-06 | 2024-03-06 |
| MFDS-2020-0010 | Fabricor | DE | MFDS | NDS | Approved | Nadia Petrova | 2023-03-10 | 2023-01-11 |
| TFDA-2024-0011 | Infeclear | FR | TFDA | Type IB Variation | Overdue | Lieselotte van der Berg | 2023-07-12 | — |
| HSA-2023-0012 | Respimax | IT | HSA | sNDA | In Progress | Priya Sharma | 2023-01-28 | — |
| CDSCO-2022-0013 | Tiotropex | ES | CDSCO | NDA | In Progress | Marcus Webb | 2023-07-05 | — |
| COFEPRIS-2021-0014 | Glucovex | NL | COFEPRIS | MAA | Pending | Priya Sharma | 2024-01-31 | 2023-05-27 |
| ANMAT-2020-0015 | Haemovance | KR | ANMAT | Lifecycle Extension | Failed | Nadia Petrova | 2022-09-05 | — |
| TITCK-2024-0016 | Retinacor | TW | TITCK | sBLA | Pending | Aisha Okonkwo | 2023-03-10 | 2024-06-20 |
| SFDA-2023-0017 | Thymomax | SG | SFDA | sMAA | Failed | Carlos Mendez | 2022-11-21 | 2024-06-04 |
| SAHPRA-2022-0018 | Pancrexan | IN | SAHPRA | Lifecycle Extension | Submitted | Marcus Webb | 2023-11-18 | 2023-03-30 |
| Roszdravnadzor-2021-0019 | Brexivance | MX | Roszdravnadzor | sBLA | Approved | Marcus Webb | 2023-08-31 | 2023-03-06 |
| MOH-IL-2020-0020 | Erenvex | AR | MOH-IL | NDA | Blocked | Aisha Okonkwo | 2023-05-08 | 2022-10-05 |
| FDA-2024-0021 | Lorlacor | TR | FDA | sBLA | In Progress | Sarah Chen | 2022-06-17 | — |
| EMA-2023-0022 | Sacuvance | SA | EMA | MAA | Blocked | Marcus Webb | 2023-12-06 | — |
| PMDA-2022-0023 | Upadvex | ZA | PMDA | Lifecycle Extension | In Progress | Lieselotte van der Berg | 2024-06-19 | 2023-06-22 |
| NMPA-2021-0024 | Semaglumax | RU | NMPA | Type IA Variation | Completed | Carlos Mendez | 2023-03-20 | — |
| ANVISA-2020-0025 | Tisavance | PL | ANVISA | MAA | Completed | James O'Brien | 2024-04-05 | — |
| HC-2024-0026 | Ozanemax | SE | HC | sNDA | Pending | Dmitri Volkov | 2022-08-10 | — |
| TGA-2023-0027 | Lecavance | BE | TGA | NDA | Blocked | Aisha Okonkwo | 2023-11-17 | 2022-12-05 |
| MHRA-2022-0028 | Crizomax | AT | MHRA | sMAA | Failed | Tomoko Ikeda | 2022-08-15 | 2024-08-24 |
| SwissMedic-2021-0029 | Atezovance | PT | SwissMedic | NDS | Active | Nadia Petrova | 2023-06-16 | — |
| MFDS-2020-0030 | Mavacor | DK | MFDS | sMAA | Submitted | Nadia Petrova | 2022-12-03 | — |
| TFDA-2024-0031 | Ocluvance | US | TFDA | sBLA | Draft | Aisha Okonkwo | 2023-09-22 | 2023-06-10 |
| HSA-2023-0032 | Verasol | EU | HSA | sBLA | Draft | James O'Brien | 2023-12-12 | 2023-02-18 |
| CDSCO-2022-0033 | Cardivex | JP | CDSCO | Type IB Variation | Active | Sarah Chen | 2024-03-11 | 2023-01-18 |
| COFEPRIS-2021-0034 | Nepricor | CN | COFEPRIS | Lifecycle Extension | Blocked | James O'Brien | 2022-11-10 | 2022-10-04 |
| ANMAT-2020-0035 | Immuvance | BR | ANMAT | MAA | Active | Dmitri Volkov | 2023-11-14 | — |
| TITCK-2024-0036 | Duplexan | CA | TITCK | Type IB Variation | Active | Sarah Chen | 2023-09-16 | — |
| SFDA-2023-0037 | Neuraclair | AU | SFDA | Lifecycle Extension | Completed | James O'Brien | 2022-07-14 | 2023-04-03 |
| SAHPRA-2022-0038 | Alzaclear | GB | SAHPRA | sBLA | Submitted | James O'Brien | 2023-11-02 | — |
| Roszdravnadzor-2021-0039 | Raredex | CH | Roszdravnadzor | Type IB Variation | Draft | Sarah Chen | 2023-06-16 | 2022-12-17 |
| MOH-IL-2020-0040 | Fabricor | DE | MOH-IL | BLA | Failed | Sarah Chen | 2024-02-26 | — |
| FDA-2024-0041 | Infeclear | FR | FDA | sNDA | Active | Dmitri Volkov | 2024-04-15 | 2022-08-16 |
| EMA-2023-0042 | Respimax | IT | EMA | NDS | Blocked | Priya Sharma | 2024-02-09 | 2024-02-20 |
| PMDA-2022-0043 | Tiotropex | ES | PMDA | Label Update | Pending | Aisha Okonkwo | 2024-05-22 | — |
| NMPA-2021-0044 | Glucovex | NL | NMPA | sMAA | Completed | Sarah Chen | 2022-08-24 | — |
| ANVISA-2020-0045 | Haemovance | KR | ANVISA | BLA | Submitted | Aisha Okonkwo | 2022-07-08 | 2022-08-24 |
| HC-2024-0046 | Retinacor | TW | HC | NDS | Approved | Carlos Mendez | 2023-10-13 | — |
| TGA-2023-0047 | Thymomax | SG | TGA | NDA | Completed | Sarah Chen | 2024-01-16 | — |
| MHRA-2022-0048 | Pancrexan | IN | MHRA | Type IB Variation | In Progress | Carlos Mendez | 2022-07-29 | 2024-09-21 |
| SwissMedic-2021-0049 | Brexivance | MX | SwissMedic | Type II Variation | In Progress | Marcus Webb | 2023-10-07 | 2024-01-03 |
| MFDS-2020-0050 | Erenvex | AR | MFDS | sMAA | Overdue | Carlos Mendez | 2022-05-07 | — |
| TFDA-2024-0051 | Lorlacor | TR | TFDA | NDS | Pending | Marcus Webb | 2023-06-12 | — |
| HSA-2023-0052 | Sacuvance | SA | HSA | Type IA Variation | Active | Aisha Okonkwo | 2022-05-26 | 2024-01-02 |
| CDSCO-2022-0053 | Upadvex | ZA | CDSCO | Type II Variation | Overdue | Sarah Chen | 2023-01-28 | 2023-03-31 |
| COFEPRIS-2021-0054 | Semaglumax | RU | COFEPRIS | sNDA | Blocked | Marcus Webb | 2023-06-18 | 2023-12-04 |
| ANMAT-2020-0055 | Tisavance | PL | ANMAT | Label Update | Draft | Tomoko Ikeda | 2023-04-09 | — |
| TITCK-2024-0056 | Ozanemax | SE | TITCK | Label Update | Approved | Carlos Mendez | 2023-11-04 | — |
| SFDA-2023-0057 | Lecavance | BE | SFDA | Lifecycle Extension | In Progress | Priya Sharma | 2024-01-09 | 2024-06-21 |
| SAHPRA-2022-0058 | Crizomax | AT | SAHPRA | sMAA | Failed | Priya Sharma | 2023-10-16 | 2023-05-27 |
| Roszdravnadzor-2021-0059 | Atezovance | PT | Roszdravnadzor | BLA | Submitted | James O'Brien | 2023-03-01 | 2022-10-20 |
| MOH-IL-2020-0060 | Mavacor | DK | MOH-IL | Lifecycle Extension | Failed | Nadia Petrova | 2023-11-13 | 2022-08-03 |
| FDA-2024-0061 | Ocluvance | US | FDA | NDA | Active | Nadia Petrova | 2022-05-19 | — |
| EMA-2023-0062 | Verasol | EU | EMA | Label Update | Failed | Tomoko Ikeda | 2022-09-05 | 2022-09-12 |
| PMDA-2022-0063 | Cardivex | JP | PMDA | NDS | Pending | Tomoko Ikeda | 2024-01-30 | 2024-01-16 |
| NMPA-2021-0064 | Nepricor | CN | NMPA | sMAA | Pending | Marcus Webb | 2022-08-29 | — |
| ANVISA-2020-0065 | Immuvance | BR | ANVISA | sNDA | Completed | Dmitri Volkov | 2022-07-11 | 2024-08-15 |
| HC-2024-0066 | Duplexan | CA | HC | sBLA | Submitted | Lieselotte van der Berg | 2023-09-28 | — |
| TGA-2023-0067 | Neuraclair | AU | TGA | NDA | Active | Carlos Mendez | 2022-10-21 | 2022-08-28 |
| MHRA-2022-0068 | Alzaclear | GB | MHRA | BLA | Approved | Dmitri Volkov | 2023-01-23 | 2022-11-05 |
| SwissMedic-2021-0069 | Raredex | CH | SwissMedic | BLA | Active | James O'Brien | 2022-10-07 | — |
| MFDS-2020-0070 | Fabricor | DE | MFDS | Label Update | Submitted | Lieselotte van der Berg | 2022-12-08 | 2022-12-10 |
| TFDA-2024-0071 | Infeclear | FR | TFDA | Type IB Variation | Completed | Nadia Petrova | 2023-08-12 | 2024-09-17 |
| HSA-2023-0072 | Respimax | IT | HSA | MAA | Failed | Carlos Mendez | 2024-06-04 | 2022-11-05 |
| CDSCO-2022-0073 | Tiotropex | ES | CDSCO | MAA | Overdue | Marcus Webb | 2023-05-01 | 2023-07-01 |
| COFEPRIS-2021-0074 | Glucovex | NL | COFEPRIS | sBLA | Draft | Nadia Petrova | 2022-12-19 | — |
| ANMAT-2020-0075 | Haemovance | KR | ANMAT | MAA | Active | Priya Sharma | 2024-04-27 | 2023-10-17 |
| TITCK-2024-0076 | Retinacor | TW | TITCK | MAA | Pending | Carlos Mendez | 2024-05-18 | — |
| SFDA-2023-0077 | Thymomax | SG | SFDA | BLA | Completed | Nadia Petrova | 2023-04-15 | 2024-08-28 |
| SAHPRA-2022-0078 | Pancrexan | IN | SAHPRA | sMAA | Active | Priya Sharma | 2023-06-26 | — |
| Roszdravnadzor-2021-0079 | Brexivance | MX | Roszdravnadzor | Lifecycle Extension | Failed | Marcus Webb | 2022-06-23 | — |
| MOH-IL-2020-0080 | Erenvex | AR | MOH-IL | sMAA | Overdue | Dmitri Volkov | 2023-03-28 | — |
| FDA-2024-0081 | Lorlacor | TR | FDA | NDA | Completed | James O'Brien | 2023-06-06 | 2024-09-20 |
| EMA-2023-0082 | Sacuvance | SA | EMA | NDA | Blocked | Dmitri Volkov | 2023-12-13 | 2023-04-06 |
| PMDA-2022-0083 | Upadvex | ZA | PMDA | Type II Variation | Blocked | Sarah Chen | 2023-04-22 | — |
| NMPA-2021-0084 | Semaglumax | RU | NMPA | Lifecycle Extension | Draft | Priya Sharma | 2024-01-31 | — |
| ANVISA-2020-0085 | Tisavance | PL | ANVISA | sNDA | Failed | Tomoko Ikeda | 2022-05-13 | 2023-10-08 |
| HC-2024-0086 | Ozanemax | SE | HC | Type II Variation | Pending | Lieselotte van der Berg | 2023-02-25 | — |
| TGA-2023-0087 | Lecavance | BE | TGA | sMAA | Failed | Priya Sharma | 2024-02-17 | — |
| MHRA-2022-0088 | Crizomax | AT | MHRA | sMAA | Completed | Nadia Petrova | 2023-03-26 | — |
| SwissMedic-2021-0089 | Atezovance | PT | SwissMedic | Type II Variation | Completed | Tomoko Ikeda | 2022-09-24 | — |
| MFDS-2020-0090 | Mavacor | DK | MFDS | NDA | Overdue | Marcus Webb | 2022-07-04 | 2022-10-22 |
| TFDA-2024-0091 | Ocluvance | US | TFDA | BLA | Approved | Sarah Chen | 2023-02-11 | 2022-09-30 |
| HSA-2023-0092 | Verasol | EU | HSA | sBLA | Failed | Nadia Petrova | 2022-05-15 | 2022-11-06 |
| CDSCO-2022-0093 | Cardivex | JP | CDSCO | NDS | Pending | Nadia Petrova | 2023-06-15 | — |
| COFEPRIS-2021-0094 | Nepricor | CN | COFEPRIS | Type IB Variation | Blocked | Marcus Webb | 2024-01-24 | 2022-09-04 |
| ANMAT-2020-0095 | Immuvance | BR | ANMAT | MAA | Submitted | Dmitri Volkov | 2022-08-07 | — |
| TITCK-2024-0096 | Duplexan | CA | TITCK | Type IB Variation | Blocked | Marcus Webb | 2023-07-22 | — |
| SFDA-2023-0097 | Neuraclair | AU | SFDA | sNDA | Completed | Dmitri Volkov | 2024-04-26 | 2023-10-17 |
| SAHPRA-2022-0098 | Alzaclear | GB | SAHPRA | sMAA | Pending | Sarah Chen | 2024-03-24 | 2024-09-01 |
| Roszdravnadzor-2021-0099 | Raredex | CH | Roszdravnadzor | MAA | Overdue | Aisha Okonkwo | 2023-08-13 | — |
| MOH-IL-2020-0100 | Fabricor | DE | MOH-IL | Label Update | Completed | James O'Brien | 2023-10-12 | 2022-10-06 |
Showing all 100 applications