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Regulatory and Quality Systems
Hikal has developed several APIs for multinational companies. Hikal adopts advanced quality systems and undertakes periodic audits and procedural documentation. Our Regulatory Affairs department supports preparation and filing of DMF's in CTD format as per international guidelines for US, EU and other countries and follow up on query responses and COS to ensure approvals within minimum time frame.

Major pharmaceutical companies have audited our facilities and rated them on par with the best in the world. Our state-of-the-art, multipurpose production plants are ISO 9001-2000 compliant and follow cGMP standards. Our plant at Bangalore is approved by USFDA, TGA and WHO GMP.
For our list of commercialized APIs and it's regulatory filing status, do refer to the table below:

   Therapeutic Category    Product Name USDMF EDMF CEP CAS Number
   Anticonvulsant    Gabapentin # 60142-96-3
   Pregabalin   148553-50-8
   Lacosamide   175481-36-4
   Antiemetic    Ondansetron   99614-02-5
   Ondansetron hydrochloride dihydrate 103639-04-9
   Antihistaminic    Triprolidine hydrochloride   6138-79-0
   Antidepressant    Bupropion hydrochloride   31677-93-7
   Venlafaxine hydrochloride 99300-78-4
   Duloxetine hydrochloride*       136434-34-9
   Antipsychotic    Quetiapine fumarate   111974-72-2
   Memantine hydrochloride   41100-52-1
   Anti-Alzheimers    Donepezil hydrochloride   120011-70-3
   Antilipemic    Gemfibrozil 25812-30-0
   Hemorheologic    Pentoxifylline 6493-05-6
   Antidiabetic    Vildagliptin     274901-16-5
   Sitagliptin phosphate monohydrate*       654671-77-9
   Canagliflozin*       842133-18-0
   Dapagliflozin*       461432-26-8
   Antithrombotic    Apixaban*       503612-47-3
   Dabigatran*       211915-06-9
   Dabigatran etexilate mesylate*       593282-20-3
   Rivaroxaban*       366789-02-8
   Antiviral    Valacyclovir hydrochloride*   124832-27-5
   Darunavir ethanolate*       635728-49-3
   Antihypertensive    Olmesartan medoxomil   144689-63-4
   Anti inflammation    Celecoxib*       169590-42-5
   Flurbiprofen*       5104-49-4
   Analgesic    Butorphanol tartrate*       42408-82-2

* Samples and Technical Package for the product can be made available on request; # JDMF Available
Site Credentials: USFDA-cGMP / TGA-GMP / KFDA (Korea) / PMDA (Japan) / AFMPS (Belgium) / EDQM / EPA / COFEPRIS (Mexico)

Note: Products protected by valid patents are not offered for commercial supply in countries wherein the sale of such products constitutes a patent infringement. Any reference to patents also includes supplementary protection certificates (SPCs) and/or patent term extension for products protected by those patents.

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