Nuray Chemicals is a manufacturer of Chlorzoxazone API. The USFDA, EU, TGA approved API manufacturing with state-of-the-art R & D facility is located at SIDCO Industrial Estate in Thiruvallur district of Tamil Nadu, India.
Nuray’s expertise and experience lie in developing pharmaceutical industry’s chemistry requirements from the synthesis of NCEs, Impurities, metabolites, method development, advanced intermediates and API’s for commercial launch.
DMF filed API’s
S.No. | Name of the API | Therapeutic Segment | USDMF status | ASMF/CEP/TGA/MEDSAFE DMF Status |
1 | Chlorzoxazone | Muscle relaxant | DMF #030862 filed. | Ready to file. |
2 | Treprostinil Sodium | Anti-hypertensive | DMF #030861 filed. | Ready to file. |
3 | Treprostinil Diolamine | Anti-hypertensive | DMF #031385 filed. | Ready to file. |
4 | Trientine Hydrochloride | Wilson’s disease | DMF #030878 filed. | TGA DMF #D19-6333311 filed |
5 | Phenoxybenzamine HCl | Anti-hypertensive agent | DMF #032443 filed. | Ready to file. |
6 | Nitisinone | Hereditary tyrosinemia type 1 | “Customer specific DMF #031250 filed. Exclusive to customer for US market. “ | Ready to file. |
7 | Diazoxide | Hypertensive & Hypoglycemia | “Customer specific DMF #031249 filed. Exclusive to customer for US market. “ | Ready to file. |
8 | Prazosin Hydrochloride | Anti-hypertensive | DMF #031628 filed. | Ready to file. |
9 | Thiothixene | Anti-psychotic & treatment of schizophrenia | “Customer specific DMF #031839 filed. Exclusive to customer for US market. “ | Ready to file. |
10 | Oxandrolone | Androgen | “Customer specific DMF #031920 filed. Exclusive to customer for US market.” | Ready to file. |
11 | Dapsone | Anti-bacterial | “Customer specific DMF #027678-filed. Exclusive to customer for US market.” | Ready to file. |
12 | Glycerol Phenylbutyrate | Hyperammonemia | “Customer specific DMF #027125-filed. Exclusive to customer for US market.” | Ready to file. |
13 | Alosetron Hydrochloride | Irritable Bowel Syndrome (IBS) | “Customer specific DMF #027378-filed. Exclusive to customer for US market.” | Ready to file. |
14 | Ramelteon | Hypnotics, sedatives & treatment of Insomnia | DMF#032444 filed. | Ready to file. |
15 | Parecoxib Sodium | Anti-inflammatory & Analgesics | — | “TGA DMF #D18-10622373 filed. MEDSAFE DMF #TT60-1443-13-1 filed. EU-ASMF DMF#EU/ASMF/00203 MHRA- Filed. Exclusive to customer for EU market. “ |
16 | Brivudine | Anti-viral | — | “EU-ASMF DMF#EU/ASMF/00193 Exclusive to customer for EU market. “ |
17 | Stiripentol | Anti-convulsant | DMF#033252 filed | “ASMF-To be filed Exclusive to customer for EU market. “ |
18 | Carglumic acid | Hyperammonemia | “Customer specific DMF #033166-filed. Exclusive to customer for US market.” | To be filed. |
19 | Atropine Sulfate Monohydrate | Anti-Spasmodic, anticholinergic & Mydriasis | Customer specific DMF #033781 filed | To be filed. |
20 | L-Methyl Folate | Dietary supplement | DMF not applicable since it belongs to nutritional supplement. | — |
21 | Dichlorphenamide | Antiglaucoma | “Customer specific DMF #034371-filed. Exclusive to customer for US market.” | Ready to file |
22 | Fludrocortisone acetate | Salt-losing adrenogenital syndrome & Addison’s disease | “Customer specific DMF filed. Exclusive to customer for US market.” | Ready to file |
23 | Methyltestosterone | Treatment of low testosterone | “Customer specific DMF #034373-filed. Exclusive to customer for US market.” | Ready to file |
24 | Piribedil | Anti-parkinsonian | — | EUDMF filed |
25 | Betaine Anhydrous | Treatment of Homocystinuria | DMF filed | Ready to file |
26 | Methsuximide | Anti-convulsant | “Customer specific DMF filed. Exclusive to customer for US market.” | Ready to file |
27 | Tafamidis Meglumine | Transthyretin amyloidosis | DMF filed | Ready to file |
28 | Tafamidis Freeacid | Transthyretin amyloidosis | DMF filed | Ready to file |
29 | Atovaquone | Anti-protozoal | DMF filed | Ready to file |
APIs under DMF filing
S.No. | Name of the API | Therapeutic Segment | USDMF status | ASMF/CEP/TGA/MEDSAFE DMF Status |
1 | Nitrofurantoin Monohydrate | Anti-infective | “Validation completed Ready to file. Waiting for customer” | Ready to file. |
2 | Peramivir | Anti-viral | “Validation completed Ready to file. Waiting for customer” | — |
3 | Propantheline Bromide | Anti-ulcer agent | Ready to file | — |
4 | Cinacalcet HCl | Calcimimtic | Developed | — |
5 | Trihexyphenidyl Hydrochlride | Anti-parkinsonian | Developed | — |
6 | Indocyanine Green | Cardiac/Liver/Diagnostic | Developed | — |
APIs under Development
S.No. | Name of the API | Therapeutic Segment | USDMF status | ASMF/CEP/TGA/MEDSAFE DMF Status |
1 | Cevimeline Hydrochloride | Cholinergic agonists-Sjogren’s syndrome | Under development | — |
2 | Pitolisant Hydrochloride | Narcolepsy, Excessive Day time sleepiness | Under development | — |
3 | Mycophenolate Mofetill | Immunosuppressants, Prophylaxis of Organ transplant rejection | Under development | — |
4 | Minocycline hydrochloride | Anti-infective, Broad Spectrum Antibiotic | Under development | — |
Nuray Chemicals Pvt Ltd
Manufacturer of Chlorzoxazone API
Plot No.111, SIDCO Industrial Estate,
Kakkalur, Thiruvallur 602 003
Tamilnadu, India.
(+91) 44 66616700
info@nuraychemicals.com
enquiry@nuraychemicals.com
http://www.nuraychemicals.com/
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