99% Sugammadex Sodium API Of GMP Manufacturer
Sugammadex sodium is a synthetic modified gamma‑cyclodextrin specifically engineered to encapsulate the neuromuscular blocking agents rocuronium and vecuronium, forming a stable water‑soluble complex that rapidly reduces free drug concentration in plasma.
Our Sugammadex Sodium API is produced in a cGMP‑compliant facility with dedicated high‑complexity synthesis lines. Each batch is tested for purity (by HPLC‑ELSD), isomeric distribution, residual starting materials (gamma‑cyclodextrin, alkylating agents), elemental impurities, and endotoxins.
This is the first and only selective relaxant-binding agent (SRBA) – a cyclodextrin derivative that represents a completely new pharmacological class, distinct from traditional acetylcholinesterase inhibitors such as neostigmine.
Sugammadex API Applications and Specifications
Manufacturer Documents Download
Applications:
For Pharmaceutical Manufacturers
Use our Sugammadex Sodium API in finished dosage forms:
Sterile intravenous solution (100 mg/mL, 2 mL and 5 mL vials) – the standard concentration for rapid reversal of rocuronium‑ or vecuronium‑induced neuromuscular blockade during surgery.
Weight‑based dosing (2 mg/kg for moderate blockade, 4 mg/kg for deep blockade, 16 mg/kg for immediate reversal) – requires precise API concentration and solution stability.
Pediatric formulations (same concentration) – approved for children aged ≥2 years.
For Compounding Pharmacies
Sugammadex is rarely compounded by 503A pharmacies due to its sterile IV requirement. However, 503B outsourcing facilities may prepare:
Batch sterile solutions for hospital contracts during commercial shortages.
Alternative concentrations (e.g., 50 mg/mL for slow infusion protocols) – off‑label, but requested in some anesthesia protocols.
Preservative‑free multi‑dose presentations are economically inefficient compared with commercial single-dose vials.
Product Name: Sugammadex Sodium API (中文名：舒更葡糖钠)
Appearance: A white to off-white powder
Solubility: 2.5mg/ml in DMF and DMSO,
Cas Number: 343306-79-6
Molecular Formula: C72H104Na8O48S8
Molecular Weight: 2178.0 g/mol
Chemical Name: 3-[[(1S,3S,5S,6S,8S,10S,11S,13S,15S,16S,18S,20S,21S,23S,25S,26S,28S,30S,31S,33S,35S,36S,38S,40S,41R,42R,43R,44R,45R,46R,47R,48R,49R,50R,51R,52R,53R,54R,55R,56R)-10,15,20,25,30,35,40-heptakis(2-carboxylatoethylsulfanylmethyl)-41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56-hexadecahydroxy-2,4,7,9,12,14,17,19,22,24,27,29,32,34,37,39-hexadecaoxanonacyclo[36.2.2.23,6.28,11.213,16.218,21.223,26.228,31.233,36]hexapentacontan-5-yl]methylsulfanyl]propanoate octasodium
HS Code: 2932999099 (Other heterocyclic compounds containing only oxygen heteroatoms-其他仅含氧杂原子的杂环化合物)
Why Choose Us As Your Sugammadex API Supplier?
Are you still looking for a reliable supplier for Sugammadex API?
Please don’t worry about anything else. We specialize in producing and exporting top-tier GMP-approved APIs, with Sugammadex being one of our flagship products.
#1. Exceptional Purity with steady stock:
We produce our Sugammadex API under strict quality-control measures, with a purity level exceeding 99%. Its high level of Purity and <0.1% single-impurity control guarantee optimal efficacy in its injectable formulations.
#2. GMP-Compliant Manufacturing with Technical Package:
Our production processes strictly adhere to Current Good Manufacturing Practices (cGMP). This compliance ensures that our Sugammadex raw material meets international standards for pharmaceutical manufacturing and pharmacy compounding, providing you with an API you can trust and register with your MOH to obtain your import permit smoothly.
FAQs About Our Sugammadex Sodium API
Q1: What is the minimum order quantity (MOQ) for Sugammadex Sodium API?
A1: Our standard packing is 5kg/tin for commercial orders, but we are willing to repack 100 grams for trial orders.
We also offer smaller packing options for quality testing, such as 1 gram or 5 Grams. If you need samples to assess our quality, please get in touch with us.
Q2: What kind of documents do you provide for regulatory compliance?
A2: We have the whole documentation set available, including the COA, MSDS, TSE/BSE, MOA, Route of Synthesis, GMP (Written Confirmation), EDMF/USDMF, etc.
We also have one team of registration specialists standing by to help you with your regulatory issues.
The point is that DMF will be provided not only for trial orders but also for commercial orders.
Q3: How long will it take to receive my shipment once we send you our formal PO?
A3: The shipping period typically depends on the destination and your order size, but you must allow time for Customs Clearance (Export and Import Clearance).
Strictly speaking, customs are beyond anyone’s control, so export clearance is relatively more straightforward and takes less time.
All we can do is get the goods ready for shipping within 3~4 days after your Order Confirmation.
Once the tracking information is available, we will keep you posted by email on the same day.
Q4. Are you a manufacturer of Sugammadex API or a trader of it?
A4: We trade on Sugammadex sodium API for our GMP manufacturer in China. Upon your request, we will provide the GMP certificate before your order is placed. All we need to do is sign an NDA before we present all the manufacturer documents.
Q5. Do you provide Sugammadex Sodium Samples free of charge for quality approval before our order?
A5: Yes, we have free samples of Sugammadex Sodium API available, but availability depends on your sample quantity.
We can provide free samples of 1 Gram or less; importers will cover the shipping cost via FedEx. However, we will charge sample fees for larger quantities. Please use the contact form above or email us for the charge details.
Q6: Does your Sugammadex factory accept official audits?
A6: Yes, we do. Please get in touch with us directly so we can schedule an audit with our factory management. Also, please share the cost details for your audit with us in advance.
Q7: What certificate does your sugammadex factory hold till 2024?
A7: We have GMP certificates from the USFDA (CoPP), NMPA (Chinese GMP), and MFDS (Korean GMP). EU Written Confirmation is underway.
Q8: Is your sugammadex suitable for pharmacy compounding and medicine manufacturing?
A8: Yes, it is. Because the Chinese FDA approved our sugammadex sodium for medicine manufacturing in 2020, we need written confirmation to export it as an API to Europe.
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