Abstract: The present invention relates to a process for the preparation of substantially pure 1-(aminomethyl)-l-cyclohexane acetic acid hydrochloride of formula (II) viz. gabapentin hydrochloride through gabalactam (I) which in turn arises from 3,3-pentamethylene glutarimide of formula (IV). The imide, 3,3-pentamethylene glutarimide of formula (IV) is obtained in a reaction between the diacid and urea under special conditions. The imide thus obtained, without isolation, is subjected to reaction with sodium hypobromite orsodium hypochlorite to yield 2-azaspiro [4,5] decan-3-one (gabalactam) of formula (I), which is transformed to gabapentin hydrochloride (II) by heating with concentrated hydrochloric acid under rigorously worked out conditions. Alternatively, the gabalactam (I) on treatment with dry hydrogen chloride gas in an alcohol preferably isopropyl alcohol yields gabalactam hydrochloride, which is transformed to gabapentin hydrochloride (II) by heating with water. Gabapentin hydrochloride (II) can then be easily converted to gabapentin in a known manner.
Year | CBR Date | CBR Number | Renwal Amount | Renwal Date | Normal Due Date | Renwal To | Renwal From | Due Date with Extension | Reneal Certificate Number |
---|---|---|---|---|---|---|---|---|---|
3rd year | 29/08/2012 | 9822 | 2000 | 29/08/2012 | 22/11/2012 | 16/12/2008 | 16/12/2007 | 22/05/2013 | 8583 |
4th year | 29/08/2012 | 9822 | 2000 | 29/08/2012 | 22/11/2012 | 16/12/2009 | 16/12/2008 | 22/05/2013 | 8583 |
5th year | 29/08/2012 | 9822 | 2000 | 29/08/2012 | 22/11/2012 | 16/12/2010 | 16/12/2009 | 22/05/2013 | 8583 |
6th year | 29/08/2012 | 9822 | 2000 | 29/08/2012 | 22/11/2012 | 16/12/2011 | 16/12/2010 | 22/05/2013 | 8583 |
7th year | 29/08/2012 | 9822 | 6000 | 29/08/2012 | 22/11/2012 | 16/12/2012 | 16/12/2011 | 22/05/2013 | 8583 |
8th year | 06/11/2012 | 15032 | 6000 | 06/11/2012 | 16/12/2012 | 16/12/2013 | 16/12/2012 | 16/06/2013 | 10854 |
9th year | 13/12/2013 | 17676 | 6000 | 13/12/2013 | 16/12/2013 | 16/12/2014 | 16/12/2013 | 16/06/2014 | 12256 |
10th year | 16/12/2014 | 23498 | 12000 | 16/12/2014 | 16/12/2014 | 16/12/2015 | 16/12/2014 | 16/06/2015 | 18668 |
11th year | 14/12/2015 | 25453 | 24000 | 14/12/2015 | 16/12/2015 | 16/12/2016 | 16/12/2015 | 16/06/2016 | 21355 |
12th year | 15/12/2016 | 34615 | 24000 | 15/12/2016 | 16/12/2016 | 16/12/2017 | 16/12/2016 | 16/06/2017 | 23722 |
13th year | 01/12/2017 | 37179 | 24000 | 01/12/2017 | 16/12/2017 | 16/12/2018 | 16/12/2017 | 16/06/2018 | 35570 |
14th year | 07/12/2018 | 35293 | 24000 | 07/12/2018 | 16/12/2018 | 16/12/2019 | 16/12/2018 | 16/06/2019 | 41938 |
15th year | 10/12/2019 | 40748 | 24000 | 10/12/2019 | 16/12/2019 | 16/12/2020 | 16/12/2019 | 16/06/2020 | 57773 |
16th year | 09/12/2020 | 41635 | 40000 | 09/12/2020 | 16/12/2020 | 16/12/2021 | 16/12/2020 | 16/06/2021 | 71538 |
17th year | 12/11/2021 | 42338 | 40000 | 12/11/2021 | 16/12/2021 | 16/12/2022 | 16/12/2021 | 16/06/2022 | 73293 |
18th year | 09/12/2022 | 49979 | 40000 | 09/12/2022 | 16/12/2022 | 16/12/2023 | 16/12/2022 | 16/06/2023 | 81848 |
19th year | -- | -- | -- | -- | -- | -- | -- | -- | -- |
20th year | -- | -- | -- | -- | -- | -- | -- | -- | -- |
Name | Date | |
---|---|---|
1 | 1845-CHE-2005-FORM-27 [30-09-2024(online)].pdf | 2024-09-30 |
2 | 1845-CHE-2005-RELEVANT DOCUMENTS [29-09-2023(online)].pdf | 2023-09-29 |
3 | 1845-CHE-2005-RELEVANT DOCUMENTS [26-09-2022(online)].pdf | 2022-09-26 |
4 | 1845-CHE-2005-RELEVANT DOCUMENTS [30-09-2021(online)].pdf | 2021-09-30 |
5 | 1845-CHE-2005-RELEVANT DOCUMENTS [29-03-2020(online)].pdf | 2020-03-29 |
6 | 1845-CHE-2005-RELEVANT DOCUMENTS [16-03-2019(online)].pdf | 2019-03-16 |
7 | 1845-CHE-2005-RELEVANT DOCUMENTS [30-03-2018(online)].pdf | 2018-03-30 |
8 | Form 27 [04-03-2017(online)].pdf | 2017-03-04 |
9 | 1845-CHE-2005_EXAMREPORT.pdf | 2016-07-02 |
10 | 1845-CHE-2005 AMENDED CLAIMS 30-05-2012.pdf | 2012-05-30 |
11 | 1845-CHE-2005 CORRESPONDENCE OTHERS 30-05-2012.pdf | 2012-05-30 |
12 | 1845-CHE-2005 AMENDED CLAIMS 25-10-2011.pdf | 2011-10-25 |
13 | 1845-CHE-2005 AMENDED PAGES OF SPECIFICATION 25-10-2011.pdf | 2011-10-25 |
14 | 1845-CHE-2005 CORRESPONDENC E OTHERS 25-10-2011.pdf | 2011-10-25 |
15 | 1845-che-2005-abstract.pdf | 2011-09-03 |
16 | 1845-che-2005-claims.pdf | 2011-09-03 |
17 | 1845-che-2005-correspondnece-others.pdf | 2011-09-03 |
18 | 1845-che-2005-description(complete).pdf | 2011-09-03 |
19 | 1845-che-2005-description(provisional).pdf | 2011-09-03 |
20 | 1845-che-2005-form 1.pdf | 2011-09-03 |
21 | 1845-che-2005-form 26.pdf | 2011-09-03 |
22 | 1845-che-2005-form 3.pdf | 2011-09-03 |
23 | 1845-che-2005-form 5.pdf | 2011-09-03 |
24 | 1845-CHE-2005 FORM-13 08-10-2010.pdf | 2010-10-08 |