Indian Patents. 195822:"PROCESS FOR THE PREPARATION OF STABLE PHARMACEUTICAL COMPOSITIONS OF GNACICLOVIR"

Title of Invention	"PROCESS FOR THE PREPARATION OF STABLE PHARMACEUTICAL COMPOSITIONS OF GNACICLOVIR"
Abstract	The present invention relates to a process for the preparation of a stable and robust pharmaceutical composition of ganciclovir containing more than 1 % water content. The water content of ganciclovir may vary from about 1 to 10%.

Full Text	The present invention relates to process for the preparation of stable pharmaceutical compositions of 9-(1,3-dihydroxy-2-propoxymethyl) guanine commonly known as ganciclovir containing more than 1% water content. Ganciclovir is a well-known anti-viral agent. It is an acyclic nucleoside analogue of 2'-deoxy guanosine that inhibits replication of herpes virus. Ganciclovir has been shown to be active against cytomegalovirus (CMV) and herpes simplex virus (HSV) in human clinical studies. US Patent No. 4,199, 574 discloses ganciclovir generically. Ganciclovir and its salts having anti-viral activity were first disclosed in US Patent No. 4,355,032 (IN 0160605 A, IN 0160604 A, IN 0160603 A and IN 0156469 A) by Syntex Inc. This patent describes the preparation of ganciclovir and also outlines the manufacture of pharmaceutical dosage forms containing the same. In a subsequent Patent US 4,642,346, Syntex Inc. disclosed a novel extremely stable anhydrous crystalline form of ganciclovir containing less than 1% water of hydration. The earlier disclosed form has been reported to be unstable owing to its hygroscopic nature and causes handling and formulating problems. The anhydrous form has been shown to be unusually resistant to water absorption and has better physical characteristics than the known hydrate form. Because of its non-hygroscopic nature, it retains better physical appearance over a longer period of time, thus enhancing the appearance of the dosage form and increasing consumer acceptance. We have surprisingly found that it is possible to prepare a stable formulation with ganciclovir containing more than 1% of water content. Ganciclovir is a high dose drug and therefore drug characteristics play an important role in determining the characteristics of the final formulation. We have found that even when the active used in the formulation is ganciclovir having more than 1% water content instead of anhydrous crystalline ganciclovir disclosed in the prior art, it does not absorb substantial amount of moisture or cause handling or formulating problems. Furthermore, the formulation containing ganciclovir, which has water content of more than 1 % exhibited acceptable stability. Accordingly, the invention thus comprises a process for the preparation of a stable pharmaceutical of ganciclovir composition comprising the steps of- a) blending ganciclovir having water content of 1% to 10% and one or more pharmaceutically acceptable excipients selected from the group consisting of diluents, disintegrants, binding agents, wetting agents, lubricants and anti- adherent agents in the concentration as herein described, b) optionally granulating the blend by wet granulation or dry granulation as herein described, c) blending the blend of step a) with extragranular excipients selected from the group consisting of lubricant and disintegrant, and d) compressing into a tablet or filling into a capsule. In fact, without intending to be limited by theories, we feel that the water content helped in binding of the drug and excipients thereby helping in formulating. It is an object of the present invention to provide a stable and robust pharmaceutical formulation comprising ganciclovir having water content of about 1% to about 10%. It is another embodiment of the present invention to provide a stable pharmaceutical composition comprising ganciclovir having more than 1.5% water content. It is another embodiment of the present invention to provide a stable pharmaceutical composition comprising ganciclovir having water content of about 4%. The invention thus relates to a process for the preparation of a stable and robust pharmaceutical composition comprising the steps of- a) blending ganciclovir having water content of about 1% to about 10% and one or more pharmaceutically acceptable excipients, b) optionally granulating the blend, c) lubricating the blend of step a) or granules of step b), and d) compressing into or filling into suitable size solid dosage form. Ganciclovir may be granulated with the excipients using any of the conventional methods used in the art including wet granulation, dry granulation or direct compression. In the "wet" granulation method, the dry solids (active ingredients, filler, disintegrant etc.) are blended and moistened with the binder solution and agglomerates or granules are build up of the moistened solids. Wet massing is continued until a desired homogeneous particle size has been achieved whereupon the granulated product is dried. Dried granules are blended with lubricants and optionally, a disintegrant and the blend is compressed into a tablet or filled into hard gelatin capsules. Another method for manufacture of granulates is the "dry" granulation method in which the active can be compacted alone or together with other pharmaceutically acceptable excipients. The granules are then mixed with extragranular excipients and compressed into a tablet or filled in hard gelatin capsules. Thus, in one embodiment of the invention, the present invention relates to a tablet dosage form prepared by compression of granules of active and pharmaceutically acceptable excipients obtained by "wet" granulation method or "dry" granulation method. In another embodiment, the present invention relates to a capsule prepared by filling granules of active and pharmaceutically acceptable excipients obtained by "wet" granulation method or "dry" granulation method in a hard gelatin capsule. The density of the granules as measured by the "bulk density" and "tapped density" is an important parameter for this formulation. The difference between these two densities describes the cohesiveness and compressibility of the substance. These two parameters are particularly important for capsule dosage form and decide the optimum filling of the capsule. Bulk density of at least 0.6 g/ml and tapped density of less than 0.8 g/ml is preferred to achieve the optimum filling of the capsules. Pharmaceutical compositions in accordance with the present invention comprises ganciclovir in a desired amount admixed with one or more pharmaceutically acceptable excipients selected from the group consisting of diluents, disintegrants, binding agents, wetting agents, lubricants and anti-adherent agents. The solid unit dosage form according to the invention may contain a filler selected from lactose, starch, mannitol, sorbitol, dextrose monohydrate, microcrystalline cellulose, dibasic calcium phosphate dihydrate, sucrose-based diluents, monobasic calcium sulphate monohydrate, calcium sulphate dihydrate, calcium lactate trihydrate, powdered cellulose and the like. The binding agent used in accordance with the present invention is selected from those commonly known in the art. Such binding agents impart sufficient cohesion to the powders to permit normal processing such as sizing, lubrication compression and packaging, but still permit the composition to disintegrate and dissolve upon ingestion. Examples of binding agents include acacia, tragacanth, sucrose, gelatin, glucose, starch, alginic acid, polyethylene glycol, guar gum, polysaccharides, bentonites, polyvinylpyrrolidone, cellulose ethers such as hydroxypropyl methylcellulose and hydroxypropyl cellulose. The binding agent is preferably present from about 0.05% to about 5% w/w of the formulation. The disintegrants used in accordance with the present invention include, either individually or in combination starches, sodium starch glycolate, clays, celluloses such as purified cellulose, methylcellulose and sodium carboxymethylcellulose, alginates, pre-gelatinized corn starches, crospovidone, gums. Disintegrants can be added at any suitable step during the preparation of the pharmaceutical composition, particularly prior to granulation or during the lubrication step prior to compression or filling the dosage form. In the present invention, disintegrant is present both intragranularly as well as extragranularly. Croscarmellose sodium is the preferred disintegrant and may be present from about 0.5 to about 7% w/w of the formulation. We have observed that use of disintegrant intragranularly as well as extragranularly enhances the disintegration time appreciably. The extragranular disintegrant is present from about 0.5% - 3% w/w of the formulation, preferably they are present at 1.5 - 2.5% w/w of the formulation. The pharmaceutical composition of the present invention optionally comprises one or more lubricants and /or glidants. Suitable lubricants and/or glidants include glyceryl behenate, metallic stearate such as magnesium stearate, stearic acid, hydrogenated vegetable oils, talc, waxes, boric acid, sodium benzoate, polyethylene glycols and sodium stearyl fumarate. The lubricant used in the present formulation is present in an amount of about 0.1% to about 2.0% w/w preferably about 0.1% to about 1.5%. Use of magnesium stearate as lubricant is preferred. Unit formula for ganciclovir dosage form is given but is not intended to limit the scope of the invention. UNIT FORMULA OF GANCICLOVIR DOSAGE FORM (Table Removed) The process for preparing ganciclovir dosage form are exemplified herein but should not be considered to limit the scope of the invention. Example 1 Ganciclovir is sifted with croscarmellose sodium and microcrystalline cellulose and granulated with a solution of polyvinyl pyrrolidone in water. The granules are dried and blended with magnesium stearate and croscarmellose sodium (extragranular). The blend is filled into a hard gelatin capsule or is compressed into a tablet. Example 2 Ganciclovir is sifted with croscarmellose sodium, polyvinyl pyrrolidone and microcrystalline cellulose. This blend is compacted and then broken to generate granules. The granules are mixed with magnesium stearate and croscarmellose sodium (extragranular). The blend is filled into a hard gelatin capsule or is compressed into a tablet. Different formulations containing variable percentages of water were subjected to stability and moisture uptake studies as shown in Table 1 and Table 2. Ganciclovir containing 1% or more water content was subjected to moisture uptake at 25°C and 60% RH in open petridish and the increase of weight was monitored. The data presented in Table 1 demonstrates there is no appreciable increase in moisture during storage. TABLE -1 Moisture uptake by ganciclovir (Table Removed) Accelerated stability testing was conducted by varying the water content of ganciclovir. The packages of final product were stored at 40°C and 75% RH for a period of 3 months. At predetermined intervals, some of the packages are opened and analyzed to determine the amount of active ingredient, water content and related impurities (RS) present in the formulation. Data generated shows that the formulation does not pick up substantial amount of water and is quite stable during the storage period. TABLE - 2 (Table Removed) WE CLAIM: 1. A process for the preparation of a stable pharmaceutical of ganciclovir composition comprising the steps of- a) blending ganciclovir having water content of 1% to 10% and one or more pharmaceutically acceptable excipients selected from the group consisting of diluents, disintegrants, binding agents, wetting agents, lubricants and anti- adherent agents in the concentration as herein described, b) optionally granulating the blend by wet granulation or dry granulation as herein described, c) blending the blend of step a) with extragranular excipients selected from the group consisting of lubricant and disintegrant, and d) compressing into a tablet or filling into a capsule. 2. The process according to claim 1 wherein the diluent is selected from group consisting of lactose, starch, mannitol, sorbitol, dextrose monohydrate, microcrystalline cellulose, dibasic calcium phosphate dihydrate, sucrose-based diluents, monobasic calcium sulphate monohydrate, calcium sulphate dihydrate, calcium lactate trihydrate, powdered cellulose and the like. 3. The process according to claim 1 wherein said binding agent is selected from group consisting of acacia, tragacanth, sucrose, gelatin, glucose, starch, alginic acid, polyethylene glycol, guar gum, polysaccharides, bentonites, polyvinylpyrrolidone, cellulose ethers such as hydroxypropyl methylcellulose and hydroxypropyl cellulose. 4. The process according to claim 1 wherein the disintegrant is selected from group consisting of starches, sodium starch glycolate, clays, celluloses such as purified cellulose, methylcellulose and sodium carboxymethylcellulose, alginates, pre-gelatinized corn starches, crospovidone, gums and mixtures thereof. 5. The process according to claim 1 wherein wet granulation is carried out with a binder solution. 6. The process according to claim 1 wherein dry granulation is carried out by compaction. 7. A process for the preparation of the preparation of a stable pharmaceutical composition of ganciclovir as described and exemplified herein.

Full Text

The present invention relates to process for the preparation of stable pharmaceutical compositions of 9-(1,3-dihydroxy-2-propoxymethyl) guanine commonly known as ganciclovir containing more than 1% water content.
Ganciclovir is a well-known anti-viral agent. It is an acyclic nucleoside analogue of 2'-deoxy guanosine that inhibits replication of herpes virus. Ganciclovir has been shown to be active against cytomegalovirus (CMV) and herpes simplex virus (HSV) in human clinical studies.
US Patent No. 4,199, 574 discloses ganciclovir generically. Ganciclovir and its salts having anti-viral activity were first disclosed in US Patent No. 4,355,032 (IN 0160605 A, IN 0160604 A, IN 0160603 A and IN 0156469 A) by Syntex Inc. This patent describes the preparation of ganciclovir and also outlines the manufacture of pharmaceutical dosage forms containing the same.
In a subsequent Patent US 4,642,346, Syntex Inc. disclosed a novel extremely stable anhydrous crystalline form of ganciclovir containing less than 1% water of hydration. The earlier disclosed form has been reported to be unstable owing to its hygroscopic nature and causes handling and formulating problems. The anhydrous form has been shown to be unusually resistant to water absorption and has better physical characteristics than the known hydrate form. Because of its non-hygroscopic nature, it retains better physical appearance over a longer period of time, thus enhancing the appearance of the dosage form and increasing consumer acceptance.
We have surprisingly found that it is possible to prepare a stable formulation with ganciclovir containing more than 1% of water content.
Ganciclovir is a high dose drug and therefore drug characteristics play an important role in determining the characteristics of the final formulation. We have found that even when the active used in the formulation is ganciclovir having more than 1% water content instead of anhydrous crystalline ganciclovir disclosed in the prior art, it does not absorb substantial amount of moisture or cause handling or formulating problems. Furthermore, the formulation containing ganciclovir, which has water content of more than 1 % exhibited acceptable stability.
Accordingly, the invention thus comprises a process for the preparation of a stable pharmaceutical of ganciclovir composition comprising the steps of-
a) blending ganciclovir having water content of 1% to 10% and one or more
pharmaceutically acceptable excipients selected from the group consisting of
diluents, disintegrants, binding agents, wetting agents, lubricants and anti-
adherent agents in the concentration as herein described,
b) optionally granulating the blend by wet granulation or dry granulation as
herein described,
c) blending the blend of step a) with extragranular excipients selected from the
group consisting of lubricant and disintegrant, and
d) compressing into a tablet or filling into a capsule.
In fact, without intending to be limited by theories, we feel that the water content helped in binding of the drug and excipients thereby helping in formulating.
It is an object of the present invention to provide a stable and robust pharmaceutical formulation comprising ganciclovir having water content of about 1% to about 10%.
It is another embodiment of the present invention to provide a stable pharmaceutical composition comprising ganciclovir having more than 1.5% water content.
It is another embodiment of the present invention to provide a stable pharmaceutical composition comprising ganciclovir having water content of about 4%.
The invention thus relates to a process for the preparation of a stable and robust pharmaceutical composition comprising the steps of-
a) blending ganciclovir having water content of about 1% to about 10% and one
or more pharmaceutically acceptable excipients,
b) optionally granulating the blend,
c) lubricating the blend of step a) or granules of step b), and
d) compressing into or filling into suitable size solid dosage form.
Ganciclovir may be granulated with the excipients using any of the conventional methods used in the art including wet granulation, dry granulation or direct compression. In the "wet" granulation method, the dry solids (active ingredients, filler, disintegrant etc.) are blended and moistened with the binder solution and agglomerates or granules are build up of the moistened solids. Wet massing is continued until a desired homogeneous particle size has been achieved whereupon the granulated product is dried. Dried granules are blended with lubricants and optionally, a disintegrant and the blend is compressed into a tablet or filled into hard gelatin capsules.
Another method for manufacture of granulates is the "dry" granulation method in which the active can be compacted alone or together with other pharmaceutically acceptable excipients. The granules are then mixed with extragranular excipients and compressed into a tablet or filled in hard gelatin capsules.
Thus, in one embodiment of the invention, the present invention relates to a tablet
dosage form prepared by compression of granules of active and pharmaceutically
acceptable excipients obtained by "wet" granulation method or "dry" granulation
method.
In another embodiment, the present invention relates to a capsule prepared by filling
granules of active and pharmaceutically acceptable excipients obtained by "wet"
granulation method or "dry" granulation method in a hard gelatin capsule.
The density of the granules as measured by the "bulk density" and "tapped density" is an important parameter for this formulation. The difference between these two densities describes the cohesiveness and compressibility of the substance. These two parameters are particularly important for capsule dosage form and decide the optimum filling of the capsule. Bulk density of at least 0.6 g/ml and tapped density of less than 0.8 g/ml is preferred to achieve the optimum filling of the capsules.
Pharmaceutical compositions in accordance with the present invention comprises ganciclovir in a desired amount admixed with one or more pharmaceutically acceptable excipients selected from the group consisting of diluents, disintegrants, binding agents, wetting agents, lubricants and anti-adherent agents.
The solid unit dosage form according to the invention may contain a filler selected from lactose, starch, mannitol, sorbitol, dextrose monohydrate, microcrystalline cellulose, dibasic calcium phosphate dihydrate, sucrose-based diluents, monobasic calcium sulphate monohydrate, calcium sulphate dihydrate, calcium lactate trihydrate, powdered cellulose and the like.
The binding agent used in accordance with the present invention is selected from those commonly known in the art. Such binding agents impart sufficient cohesion to the powders to permit normal processing such as sizing, lubrication compression and packaging, but still permit the composition to disintegrate and dissolve upon ingestion. Examples of binding agents include acacia, tragacanth, sucrose, gelatin, glucose, starch, alginic acid, polyethylene glycol, guar gum, polysaccharides, bentonites, polyvinylpyrrolidone, cellulose ethers such as hydroxypropyl methylcellulose and hydroxypropyl cellulose. The binding agent is preferably present from about 0.05% to about 5% w/w of the formulation.
The disintegrants used in accordance with the present invention include, either individually or in combination starches, sodium starch glycolate, clays, celluloses such as purified cellulose, methylcellulose and sodium carboxymethylcellulose, alginates, pre-gelatinized corn starches, crospovidone, gums. Disintegrants can be added at any suitable step during the preparation of the pharmaceutical composition, particularly prior to granulation or during the lubrication step prior to compression or filling the dosage form. In the present invention, disintegrant is present both intragranularly as well as extragranularly.
Croscarmellose sodium is the preferred disintegrant and may be present from about 0.5 to about 7% w/w of the formulation. We have observed that use of disintegrant intragranularly as well as extragranularly enhances the disintegration time appreciably. The extragranular disintegrant is present from about 0.5% - 3% w/w of the formulation, preferably they are present at 1.5 - 2.5% w/w of the formulation.
The pharmaceutical composition of the present invention optionally comprises one or more lubricants and /or glidants. Suitable lubricants and/or glidants include glyceryl behenate, metallic stearate such as magnesium stearate, stearic acid, hydrogenated vegetable oils, talc, waxes, boric acid, sodium benzoate, polyethylene glycols and sodium stearyl fumarate. The lubricant used in the present formulation is present in an amount of about 0.1% to about 2.0% w/w preferably about 0.1% to about 1.5%. Use of magnesium stearate as lubricant is preferred.
Unit formula for ganciclovir dosage form is given but is not intended to limit the scope of the invention.
UNIT FORMULA OF GANCICLOVIR DOSAGE FORM

(Table Removed)
The process for preparing ganciclovir dosage form are exemplified herein but should not be considered to limit the scope of the invention.
Example 1
Ganciclovir is sifted with croscarmellose sodium and microcrystalline cellulose and granulated with a solution of polyvinyl pyrrolidone in water. The granules are dried and blended with magnesium stearate and croscarmellose sodium (extragranular). The blend is filled into a hard gelatin capsule or is compressed into a tablet.
Example 2
Ganciclovir is sifted with croscarmellose sodium, polyvinyl pyrrolidone and microcrystalline cellulose. This blend is compacted and then broken to generate granules. The granules are mixed with magnesium stearate and croscarmellose sodium
(extragranular). The blend is filled into a hard gelatin capsule or is compressed into a tablet.
Different formulations containing variable percentages of water were subjected to stability and moisture uptake studies as shown in Table 1 and Table 2.
Ganciclovir containing 1% or more water content was subjected to moisture uptake at 25°C and 60% RH in open petridish and the increase of weight was monitored. The data presented in Table 1 demonstrates there is no appreciable increase in moisture during storage.
TABLE -1
Moisture uptake by ganciclovir

(Table Removed)
Accelerated stability testing was conducted by varying the water content of ganciclovir. The packages of final product were stored at 40°C and 75% RH for a period of 3 months. At predetermined intervals, some of the packages are opened and analyzed to determine the amount of active ingredient, water content and related impurities (RS) present in the formulation. Data generated shows that the formulation does not pick up substantial amount of water and is quite stable during the storage period.
TABLE - 2

(Table Removed)

WE CLAIM:
1. A process for the preparation of a stable pharmaceutical of ganciclovir
composition comprising the steps of-
a) blending ganciclovir having water content of 1% to 10% and one or more
pharmaceutically acceptable excipients selected from the group consisting of
diluents, disintegrants, binding agents, wetting agents, lubricants and anti-
adherent agents in the concentration as herein described,
b) optionally granulating the blend by wet granulation or dry granulation as
herein described,
c) blending the blend of step a) with extragranular excipients selected from the
group consisting of lubricant and disintegrant, and
d) compressing into a tablet or filling into a capsule.

2. The process according to claim 1 wherein the diluent is selected from group
consisting of lactose, starch, mannitol, sorbitol, dextrose monohydrate,
microcrystalline cellulose, dibasic calcium phosphate dihydrate, sucrose-based
diluents, monobasic calcium sulphate monohydrate, calcium sulphate dihydrate,
calcium lactate trihydrate, powdered cellulose and the like.
3. The process according to claim 1 wherein said binding agent is selected from
group consisting of acacia, tragacanth, sucrose, gelatin, glucose, starch, alginic
acid, polyethylene glycol, guar gum, polysaccharides, bentonites,
polyvinylpyrrolidone, cellulose ethers such as hydroxypropyl methylcellulose and
hydroxypropyl cellulose.
4. The process according to claim 1 wherein the disintegrant is selected from group
consisting of starches, sodium starch glycolate, clays, celluloses such as
purified cellulose, methylcellulose and sodium carboxymethylcellulose, alginates,
pre-gelatinized corn starches, crospovidone, gums and mixtures thereof.
5. The process according to claim 1 wherein wet granulation is carried out with a
binder solution.
6. The process according to claim 1 wherein dry granulation is carried out by
compaction.
7. A process for the preparation of the preparation of a stable pharmaceutical
composition of ganciclovir as described and exemplified herein.

Documents:

1058-del-2002-abstract.pdf

1058-del-2002-claims.pdf

1058-del-2002-correspondence-others.pdf

1058-del-2002-correspondence-po.pdf

1058-del-2002-description (complete).pdf

1058-del-2002-form-1.pdf

1058-del-2002-form-2.pdf

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Patent Number

195822

Indian Patent Application Number

1058/DEL/2002

PG Journal Number

31/2009

Publication Date

31-Jul-2009

Grant Date

21-Apr-2006

Date of Filing

22-Oct-2002

Name of Patentee

RANBAXY LABORATORIES LIMITED,

Applicant Address

19, NEHRU PLACE, NEW DELHI-110019, INDIA

Inventors:

#	Inventor's Name	Inventor's Address
1	RAJEEV SHANKAR MATHUR	RANBAXY LABORATORIES LIMITED, PLOT NO.20, SECTOR-18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001(HARYANA) INDIA
2	PANANCHUKUNNATH MANOJ KUMAR	RANBAXY LABORATORIES LIMITED, PLOT NO.20, SECTOR-18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001(HARYANA) INDIA
3	SUNILENDU BHUSHAN ROY	RANBAXY LABORATORIES LIMITED, PLOT NO.20, SECTOR-18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001(HARYANA) INDIA
4	RAJIV MALIK	RANBAXY LABORATORIES LIMITED, PLOT NO.20, SECTOR-18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001(HARYANA) INDIA
5	RAJEEV SHANKAR MATHUR	RANBAXY LABORATORIES LIMITED, PLOT NO.20, SECTOR-18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001(HARYANA) INDIA
6	PANANCHUKUNNATH MANOJ KUMAR	RANBAXY LABORATORIES LIMITED, PLOT NO.20, SECTOR-18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001(HARYANA) INDIA
7	SUNILENDU BHUSHAN ROY	RANBAXY LABORATORIES LIMITED, PLOT NO.20, SECTOR-18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001(HARYANA) INDIA
8	RAJIV MALIK	RANBAXY LABORATORIES LIMITED, PLOT NO.20, SECTOR-18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001(HARYANA) INDIA
9	RAJEEV SHANKAR MATHUR	RANBAXY LABORATORIES LIMITED, PLOT NO.20, SECTOR-18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001(HARYANA) INDIA
10	PANANCHUKUNNATH MANOJ KUMAR	RANBAXY LABORATORIES LIMITED, PLOT NO.20, SECTOR-18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001(HARYANA) INDIA
11	SUNILENDU BHUSHAN ROY	RANBAXY LABORATORIES LIMITED, PLOT NO.20, SECTOR-18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001(HARYANA) INDIA
12	RAJIV MALIK	RANBAXY LABORATORIES LIMITED, PLOT NO.20, SECTOR-18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001(HARYANA) INDIA

PCT International Classification Number

C07D 473/18

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA