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Sugammadex | CAS No: 343306-71-8 | GMP-certified suppliers
A medication that reverses neuromuscular blockade induced by rocuronium or vecuronium bromide to restore muscle function during surgical procedures in adults and pediatric patients.
Therapeutic categories
Primary indications
- Sugammadex is indicated for the reversal of neuromuscular blockade induced by [rocuronium] bromide or [vecuronium] bromide in adults and pediatric patients ≥2 years old who are undergoing surgery
Product Snapshot
- Sugammadex is an injectable peptide formulated for intravenous administration
- It is primarily used for the reversal of neuromuscular blockade induced by rocuronium or vecuronium during surgery
- The product holds regulatory approval in key markets including the US, Canada, and the EU
Clinical Overview
Sugammadex is a modified gamma-cyclodextrin oligosaccharide that acts by encapsulating steroidal neuromuscular blockers in a 1:1 molecular ratio. This encapsulation forms tight, water-soluble complexes predominantly with rocuronium, followed by vecuronium, and to a lesser extent with pancuronium. By creating a concentration gradient, sugammadex promotes the movement of rocuronium from the neuromuscular junction into the plasma, effectively reversing the neuromuscular blockade. Once bound, the complexes reduce free rocuronium concentration at the site of action, enabling more rapid restoration of muscle function.
Sugammadex is approved for use in both adult and pediatric patients aged 2 years and older undergoing surgery. It was first authorized by the United States Food and Drug Administration in December 2015 and is marketed under the brand name Bridion by Merck Sharp and Dohme.
Pharmacokinetic details relevant to sugammadex include its hydrophilic nature and rapid distribution within plasma. Sugammadex is primarily eliminated unchanged via renal excretion. Considerations for renal impairment should be taken into account when using this agent.
Safety assessments have identified typical concerns related to hypersensitivity and rare instances of bradycardia. There is no significant anticholinergic activity associated with sugammadex, contrasting with other reversal agents such as neostigmine.
From an API sourcing perspective, ensuring strict compliance with quality standards is critical due to the compound’s specific cyclodextrin structure and the necessity for high purity to avoid interference with the pharmacodynamic activity. Suppliers should provide comprehensive analytical documentation including identity, assay, impurity profiles, and residual solvents to meet regulatory and clinical requirements.
Identification & chemistry
| Generic name | Sugammadex |
|---|---|
| Molecule type | Small molecule |
| CAS | 343306-71-8 |
| UNII | 361LPM2T56 |
| DrugBank ID | DB06206 |
Pharmacology
| Summary | Sugammadex is a modified gamma-cyclodextrin that selectively encapsulates steroidal neuromuscular blocking agents, primarily rocuronium and vecuronium. By forming tight 1:1 water-soluble complexes, it facilitates the rapid removal of these agents from the neuromuscular junction into the plasma, reversing neuromuscular blockade. This mechanism enhances the diffusion gradient and reduces free concentrations of neuromuscular blockers to restore muscle function. |
|---|---|
| Mechanism of action | Sugammadex is a modified gamma-cyclodextrin which forms very tight water soluble complexes at a 1:1 ratio with steroidal neuromuscular blocking drugs (rocuronium > vecuronium >> pancuronium). Sugammadex creates a concentration gradient which favors movement of rocurionium from the neuromuscular junction into the plasma, which quickly reverses rocuronium-induced neuromuscular blockade. The free rocuronium in the plasma are then bound tightly to sugammadex, assisting the diffusion of the remaining rocuronium molecules out of the neuromuscular junction and increasing bound and free rocuronium in the plasma. |
ADME / PK
| Absorption | Sugammadex is administered intravenously. |
|---|---|
| Half-life | About 2 hours |
| Protein binding | Sugammadex does not bind plasma proteins. |
| Metabolism | No metabolites of sugammadex were observed during clinical studies. |
| Route of elimination | Renal excretion of unchanged product. >90 of dose is excreted within 24 hours. 0.02% is excreted in feces and air. |
| Volume of distribution | At steady state, the volume of distribution is 11-14 L in adult patients with normal renal function. |
| Clearance | 88L/min |
Formulation & handling
- Sugammadex is a small molecule oligosaccharide formulated exclusively for intravenous injection or parenteral use.
- It demonstrates high water solubility (26.6 g/L) and a strongly negative LogP (-5.4), indicating hydrophilic characteristics suitable for aqueous formulations.
- Formulation and handling should consider its carbohydrate-based structure but stability data suggest standard aseptic conditions for injectable solutions are appropriate.
Regulatory status
| Lifecycle | The API’s key patents in the United States expired between August 2020 and January 2021, indicating the product is in the mature phase of its lifecycle in the US market. It is also marketed in Canada and the EU, where patent statuses may vary, potentially influencing lifecycle stages regionally. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Sugammadex is primarily supplied by a limited number of originator companies offering branded products under the name Bridion across the US, Canada, and EU markets. Patent protections with expiration dates in 2020 and 2021 indicate that generic competition has likely entered or will soon enter the market, impacting the supply landscape. |
|---|
Safety
| Toxicity | Patients with severe renal impairment (with creatinine clearance below 30 mL/min) should avoid use of drug as their clearance of the drug is reduced and there is inconsistent evidence about its safety in this subset of patients. |
|---|
- 1
- Clearance of the compound is reduced in subjects with severe renal impairment (creatinine clearance ‹30 mL/min)
- Safety data in this population are limited
Sugammadex is a type of Neuromuscular blocking agents
Neuromuscular blocking agents (NMBAs) belong to a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the field of medicine. These agents play a crucial role in the neuromuscular blockade, a pharmacological state that inhibits the transmission of nerve impulses at the neuromuscular junction. By doing so, NMBAs induce temporary paralysis in skeletal muscles, making them indispensable in various medical procedures and surgical interventions.
NMBAs work by targeting the neuromuscular junction, where motor neurons communicate with skeletal muscle fibers. They achieve this by interfering with the transmission of acetylcholine, a neurotransmitter responsible for signaling muscle contraction. By blocking the action of acetylcholine, NMBAs prevent muscle movement and promote muscle relaxation, allowing surgeons to perform intricate procedures more effectively.
These pharmaceutical APIs are extensively used during surgeries requiring muscle relaxation, such as abdominal surgeries, orthopedic procedures, and endotracheal intubation. Furthermore, NMBAs find application in critical care settings, assisting in mechanical ventilation and facilitating optimal patient-ventilator synchronization.
It is worth mentioning that the usage of NMBAs necessitates close monitoring and expertise, as their administration requires precise dosing and careful titration to maintain the desired level of muscle relaxation while avoiding excessive paralysis. Anesthesia professionals and intensivists meticulously administer these agents, taking into consideration factors such as patient age, weight, and individual response.
In conclusion, Neuromuscular blocking agents are an essential API category within the pharmaceutical industry, vital for achieving muscle relaxation during surgical procedures and critical care management. Their precise and skillful utilization significantly contributes to the success of medical interventions and patient outcomes.
Sugammadex API manufacturers & distributors
Compare qualified Sugammadex API suppliers worldwide. We currently have 7 companies offering Sugammadex API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF | 229 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, JDMF, KDMF, MSDS, USDMF, WC | 170 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| PLIVA | Producer | Czech Republic | Croatia | CoA, GMP | 31 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, ISO9001, USDMF | 157 products |
| Shandong Chenghui Shuangd... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, WC | 98 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 140 products |
When sending a request, specify which Sugammadex API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Sugammadex API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
