CINDELLA is a thioctic acid injection, and the Korean drug register shows it is not a one-off formula. Daehan New Pharm filed it in September 2012 with a specific set of four additives. Today 21 live Korean filings from 21 different companies declare exactly the same four, and none of them was filed earlier than CINDELLA. That history is the most useful fact for reading a CINDELLA carton, because the products that most resemble it are its neighbours on paper.
What CINDELLA is, as the Korean register records it
CINDELLA is a prescription-only medicine filed in Korea by Daehan New Pharm under the name 신델라주(티옥트산). The parenthesis is part of the licensed name and states the substance: thioctic acid, the racemic form usually sold in English as alpha lipoic acid. There is one CINDELLA filing and one presentation.
| Filed product name | 신델라주(티옥트산) |
|---|---|
| English name on file | Cindella Inj. |
| Holder | Daehan New Pharm (대한뉴팜) |
| Filed | 13 September 2012, by notification (신고) |
| Declared active | Thioctic acid, 5 mg per 1 mL, Korean Pharmacopoeia grade |
| Declared additives | Sodium bicarbonate, urea, hydrochloric acid, water for injection |
| Pack | 10 ampoules per box, 5 mL per ampoule |
| Appearance on file | Pale yellow, clear solution in a brown ampoule |
| Storage and shelf life on file | Light-protected sealed container, 1 to 30°C; 36 months from manufacture |
| ATC code | A16AX01 |
| Registered barcodes | 8806699057804, 8806699057811, 8806699057828, 8806699057835 |
Five milligrams per millilitre in a 5 mL ampoule is 25 mg per ampoule, which is the figure most listings print. The two numbers describe the same thing: the register states concentration, the carton and listing usually state the ampoule total.
The filing route is notification rather than full licensing. That is not a mark against CINDELLA. Every one of the 29 live thioctic acid injection filings in Korea went through notification, and our explainer on licensed versus notified Korean drug filings covers what the two routes mean for an importer. The ATC code, A16AX01, places it with other alimentary tract and metabolism products; 26 of the 29 live thioctic acid injection filings carry the same code, and the other three leave the field blank.
The urea and bicarbonate formula, and who filed it first
Thioctic acid on its own is poorly soluble in water, so every injection filing declares what else goes into the solution. Korean filings solve that in one of three ways, and the additive list on the licence tells you which one a product uses.
| Formulation on file | Strength on file | Filings (live) | Earliest filing |
|---|---|---|---|
| Thioctic acid with sodium bicarbonate, urea, hydrochloric acid, water for injection | 5 mg/mL, 5 mL ampoules | 25 (21) | CINDELLA, September 2012 |
| Thioctic acid tromethamine (a salt) with tromethamine, water for injection | 39.7 mg/mL, 8 to 24 mL ampoules | 7 (6) | March 2005 |
| Thioctic acid with benzyl alcohol and sodium phosphates, water for injection | 5 mg/mL, 5 mL ampoules | 2 (2) | October 2008 |
The first row is the largest group in the category, and CINDELLA heads it. The next filing with the same four additives came twenty months later, in May 2014. The other live ones followed between 2014 and 2019, each from a different holder. Of the 21 live filings with this formula, no two belong to the same company.
Read from the register alone, the 21 are identical on the points it records: the same active at 5 mg/mL, the same four additives, the same 5 mL ampoule, and nearly the same appearance description. What separates them is the holder, the filed name, the barcode and, in a few cases, the shelf life. For a buyer, that means the formula on a carton confirms the type of product but does not confirm it is CINDELLA. The identity sits in the name, holder and barcode.
CINDELLA and Lipotocin are different substances, not different strengths
The second row of the table is where most confusion starts. Thioctic acid tromethamine is a salt of thioctic acid, filed under its own ingredient string, at 39.7 mg/mL, in larger ampoules. In English, both kinds get called an ALA injection.
Lipotocin, which we also supply, is one of the tromethamine salt filings, held by Huons in 12 mL ampoules. It is not a stronger CINDELLA. The two carry different ingredient strings, different holders, different additive lists and different volumes, and a comparison of their milligram totals mixes a salt weight with an acid weight. Daehan New Pharm itself holds one filing of each kind: CINDELLA for the acid and a separate tromethamine salt filing. How the register splits the three thioctic acid substances, and how to read that split in a Korean product name, is the subject of our earlier guide to reading a thioctic acid injectable.
Shelf life: 36 months where most of its group say 24
Among the 21 live filings that share CINDELLA's formula, 16 state a shelf life of 24 months and five state 36 months. CINDELLA is one of the five.
Its change history has a single entry, dated 10 July 2018: a revision to storage method and shelf life. The register does not publish the wording a field held before a revision, so it cannot show whether the 36 months dates from 2012 or from that change. What it does show is the current figure, and that a CINDELLA carton printed before July 2018 may describe storage or shelf life differently from one printed after, while belonging to the same filing.
The practical point for a buyer is that an expiry date roughly three years after the manufacturing date is consistent with the CINDELLA record. On a carton from one of its 24-month neighbours it would not be, which makes the two dates on the box a small additional check on which filing you are holding.
How to verify CINDELLA before it ships
Read the full Korean name. The filed name is 신델라주(티옥트산). Three other live filings with the same formula have names that look or sound close: 뉴델라주 (Newdella, Ilsung IS), 아이델라주 (Idella, Ajou Pharm) and 치오델라주 (Thiodela, Shinpoong Pharm). A carton with one of those names is a different product from a different company, even though the register describes its contents identically.
Confirm the holder. CINDELLA is filed by Daehan New Pharm, and no other company holds a CINDELLA filing. Documents naming a different holder do not match the register.
Check the presentation. The record describes 5 mL brown ampoules, ten to a box, holding a pale yellow clear solution at 5 mg/mL. A CINDELLA carton describing vials, syringes, a different volume or a different strength does not correspond to the filing.
Match the barcode. The four registered codes all begin 88066990578: 8806699057804, 8806699057811, 8806699057828 and 8806699057835. A code that matches none of them is the most direct sign of a relabelled carton. A blank result in a consumer barcode app is not, for reasons covered in this week's question on blank barcode scans.
Do not let the brand name stretch. Cindella Healer and Cindella i are syringe products sold under a similar name. They are not presentations of the CINDELLA thioctic acid filing, and the register entry above says nothing about them.
Sourcing CINDELLA
KSTATION supplies CINDELLA Inj, 5 mL × 10 ampoules through official Korean channels. For buyers comparing it with the tromethamine salt form, Lipotocin, 12 mL × 10 ampoules is the Huons filing described above. Both sit with the rest of the range under vitamins and injectables.
Frequently asked
What is CINDELLA injection?
CINDELLA is a prescription-only thioctic acid injection filed in Korea by Daehan New Pharm on 13 September 2012. It is filed at 5 mg per mL in 5 mL brown ampoules, ten per box, under the Korean name 신델라주(티옥트산) and the English name Cindella Inj.
What is in CINDELLA besides thioctic acid?
The register declares sodium bicarbonate, urea, hydrochloric acid and water for injection. Twenty other live Korean thioctic acid injections declare the same four additives; CINDELLA's filing is the oldest of them.
Is CINDELLA the same as Cindella Healer?
No. Cindella Healer and Cindella i are separate syringe products sold under a similar name. The CINDELLA drug filing covers only the 5 mL thioctic acid ampoule held by Daehan New Pharm.
How do you verify authentic CINDELLA?
Check that the Korean name reads 신델라주(티옥트산) and not a similar name such as 뉴델라주 or 치오델라주, that the holder is Daehan New Pharm, that the box holds ten 5 mL ampoules at 5 mg/mL, and that the barcode is one of the four registered codes beginning 88066990578.
Sources and references
- Ministry of Food and Drug Safety (MFDS), Korean drug product register, detailed record for 신델라주(티옥트산), including holder, filing route, declared active and additives, pack, appearance, storage, shelf life, ATC code, barcodes and change history, retrieved 8 October 2026.
- MFDS drug product register, ingredient query for thioctic acid, 34 injection filings with detailed records read for declared additives, strength, pack and shelf life, retrieved 8 October 2026.
- KSTATION product records for CINDELLA Inj and Lipotocin Inj, retrieved 8 October 2026.
- KSTATION editorial policy, on how product and register facts are separated in our writing.
Register figures are a reading taken on 8 October 2026. Filings and their detailed records change without notice. This article describes holders, declared ingredients, barcodes and carton facts for professional buyers. It says nothing about what the product is indicated for, how it is prepared or administered, or how it compares clinically with other products.
