20 Aug 2024
// PRESS RELEASE
09 Aug 2024
// PRESS RELEASE
30 Jul 2024
// REUTERS
DATA COMPILATION
#PharmaFlow
Latest Content by PharmaCompass
KEY PRODUCTS
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
About
CPhI India 2024CPhI India 2024
Industry Trade Show
Attending
26-28 November, 2024
Industry Trade Show
Not Confirmed
14-17 October, 2024
The MedTech ConferenceThe MedTech Conference
Industry Trade Show
Not Confirmed
15-17 October, 2024
CONTACT DETAILS
Events
Webinars & Exhibitions
CPhI India 2024CPhI India 2024
Industry Trade Show
Attending
26-28 November, 2024
Industry Trade Show
Not Confirmed
14-17 October, 2024
The MedTech ConferenceThe MedTech Conference
Industry Trade Show
Not Confirmed
15-17 October, 2024
Digital content 
CORPORATE CONTENT #SupplierSpotlight
NEWS #PharmaBuzz
20 Aug 2024
// PRESS RELEASE
https://granulesindia.com/wp-content/uploads/2024/08/ANDA-Approval-for-Glycopyrrolate-Oral-Solution.pdf
09 Aug 2024
// PRESS RELEASE
https://granulesindia.com/wp-content/uploads/2024/08/Trazodone-Tabs-approval-PR.pdf
30 Jul 2024
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/granules-indias-q1-profit-nearly-triples-strong-demand-2024-07-30/
30 Jul 2024
// PRESS RELEASE
https://granulesindia.com/wp-content/uploads/2024/07/Press-Release-Q1-FY25.pdf
15 May 2024
// PRESS RELEASE
https://granulesindia.com/wp-content/uploads/2024/05/Press-Release-Q4-FY24-.pdf
30 Apr 2024
// PRESS RELEASE
https://granulesindia.com/wp-content/uploads/2024/05/Press-Release-Q4-FY24-.pdf
Click Us!
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-28
Pay. Date : 2016-07-01
DMF Number : 16625
Submission : 2003-06-06
Status : Active
Type : II
Certificate Number : R1-CEP 2004-124 - Rev 07
Issue Date : 2023-05-05
Type : Chemical
Substance Number : 931
Status : Valid
Registration Number : 305MF10066
Registrant's Address : 2nd Floor, 3rd Block My Home Hub, Madhapur, Hyderabad, Telangana 500081 India
Initial Date of Registration : 2023-05-24
Latest Date of Registration :
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0028
Address of the Firm :
NDC Package Code : 62207-012
Start Marketing Date : 2017-10-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Agerson Bio Co., Ltd.
Registration Date : 2023-01-13
Registration Number : 20050831-37-C-34-05(13)
Manufacturer Name : M/s Granules India Limited
Manufacturer Address : Plot No.: 15A/1, Phase-Ⅲ, IDA, Jeedimetla, Quthbullapur (M), Medchal-Malkajgiri District - 500 055 Telangana State, India
| Available Reg. Filing : ROW, ASMF, CA, BR, MX |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17722
Submission : 2004-09-22
Status : Active
Type : II
Certificate Number : R1-CEP 1998-047 - Rev 06
Issue Date : 2018-01-19
Type : Chemical
Substance Number : 49
Status : Valid
Registration Number : 228MF10061
Registrant's Address : 2nd Floor, 3rd Block, My Home Hub, Madhapur, Hyderabad, Telangana 500081 India
Initial Date of Registration : 2016-02-24
Latest Date of Registration :
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0116
Address of the Firm :
NDC Package Code : 62207-100
Start Marketing Date : 2009-10-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (90mg/100mg)
Marketing Category : EXPORT ONLY
Registrant Name : Insung Trading Co., Ltd.
Registration Date : 2023-03-29
Registration Number : 20050915-32-C-198-10(B)
Manufacturer Name : Granules India Ltd
Manufacturer Address : H.No.6-5 & 6-11, Temple Road, Bonthapally Village, Gummadidala Mandal, Sangareddy Dist-502313, Telangana State, India.
| Available Reg. Filing : ROW, ASMF, CA, MX |
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-03-23
Pay. Date : 2015-12-14
DMF Number : 30063
Submission : 2016-02-01
Status : Active
Type : II
Certificate Number : R1-CEP 2009-349 - Rev 01
Issue Date : 2016-05-26
Type : Chemical
Substance Number : 1084
Status : Valid
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm :
NDC Package Code : 62207-001
Start Marketing Date : 2016-12-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/1)
Marketing Category : EXPORT ONLY
| Available Reg. Filing : ASMF, CN, ROW |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-19
Pay. Date : 2014-03-11
DMF Number : 14372
Submission : 1999-08-30
Status : Active
Type : II
Certificate Number : R0-CEP 2021-332 - Rev 00
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 615
Status : Valid
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0028
Address of the Firm :
NDC Package Code : 62207-500
Start Marketing Date : 2017-08-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (95mg/100mg)
Marketing Category : EXPORT ONLY
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2021-11-30
Registration Number : 20210309-211-J-857(3)
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, Telangana State, India
| Available Reg. Filing : ASMF, ROW, BR |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17723
Submission : 2004-09-22
Status : Active
Type : II
Certificate Number : R0-CEP 2021-312 - Rev 00
Issue Date : 2022-01-18
Type : Chemical
Substance Number : 931
Status : Valid
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0116
Address of the Firm :
NDC Package Code : 62207-012
Start Marketing Date : 2017-10-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Agerson Bio Co., Ltd.
Registration Date : 2023-01-13
Registration Number : 20050831-37-C-34-05(13)
Manufacturer Name : M/s Granules India Limited
Manufacturer Address : Plot No.: 15A/1, Phase-Ⅲ, IDA, Jeedimetla, Quthbullapur (M), Medchal-Malkajgiri District - 500 055 Telangana State, India
| Available Reg. Filing : ROW, ASMF, CA, BR, MX |
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-08-22
Pay. Date : 2023-07-17
DMF Number : 37593
Submission : 2022-12-28
Status : Active
Type : II
Certificate Number : CEP 2023-010 - Rev 00
Issue Date : 2024-02-15
Type : Chemical
Substance Number : 2857
Status : Valid
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm :
NDC Package Code : 62207-019
Start Marketing Date : 2023-01-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
| Available Reg. Filing : ROW |
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-09-19
Pay. Date : 2016-07-12
DMF Number : 30604
Submission : 2016-08-16
Status : Active
Type : II
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm :
NDC Package Code : 62207-002
Start Marketing Date : 2018-06-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20998
Submission : 2007-10-31
Status : Active
Type : II
Certificate Number : R1-CEP 2009-201 - Rev 03
Issue Date : 2018-11-27
Type : Chemical
Substance Number : 615
Status : Valid
NDC Package Code : 62207-500
Start Marketing Date : 2017-08-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (95mg/100mg)
Marketing Category : EXPORT ONLY
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2021-11-30
Registration Number : 20210309-211-J-857(3)
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, Telangana State, India
| Available Reg. Filing : ASMF, ROW, BR |
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-09
Pay. Date : 2022-02-08
DMF Number : 22898
Submission : 2009-05-22
Status : Active
Type : II
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm :
NDC Package Code : 62207-009
Start Marketing Date : 2018-09-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hiple Co., Ltd.
Registration Date : 2016-05-02
Registration Number : 20090720-40-C-258-15(3)
Manufacturer Name : Granules India Limited
Manufacturer Address : Plot No 8, Jawaharlal Nehru Pharma City, Tadi Village, Parawada Mandal, Vitsakhapatnam-531021, Andhra Pradesh, India
| Available Reg. Filing : ASMF, CN, ROW |
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-09
Pay. Date : 2020-09-08
DMF Number : 22711
Submission : 2009-04-02
Status : Active
Type : II
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm :
NDC Package Code : 62207-007
Start Marketing Date : 2018-04-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hiple Co., Ltd.
Registration Date : 2016-05-02
Registration Number : 20100616-122-G-58-21(2)
Manufacturer Name : Granules India Limited (Unit-IV)
Manufacturer Address : Plat No.8, JN. Pharma City, Tadi (V), Parawada Mandal, Visakhapatnam District, Andhra Pradesh India
| Available Reg. Filing : ASMF, CN |
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Details:
Desyrel-Generic (trazodone hydrochloride) is a selective serotonin reuptake inhibitor indicated for the treatment of patients with major depressive disorder.
Lead Product(s): Trazodone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Desyrel-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 09, 2024
Lead Product(s) : Trazodone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Granules India Gains ANDA approval for Trazodone Tablets
Details : Desyrel-Generic (trazodone hydrochloride) is a selective serotonin reuptake inhibitor indicated for the treatment of patients with major depressive disorder.
Brand Name : Desyrel-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 09, 2024
Details:
Pantoprazole Sodium Delayed-Release tablets are indicated for short-term treatment of Erosive Esophagitis Associated with GERD and Pathological Hypersecretory Conditions.
Lead Product(s): Pantoprazole Sodium
Therapeutic Area: Gastroenterology Brand Name: Protonix-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2023
Lead Product(s) : Pantoprazole Sodium
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Granules India Limited Received ANDA Approval for Pantoprazole Sod Delayed-Release Tablets
Details : Pantoprazole Sodium Delayed-Release tablets are indicated for short-term treatment of Erosive Esophagitis Associated with GERD and Pathological Hypersecretory Conditions.
Brand Name : Protonix-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 13, 2023
Details:
Sildenafil is an inhibitor of cyclic GMP specific PDE type 5, the predominant enzyme metabolizing cyclic GMP in the corpus cavernosum. It is indicated for pulmonary arterial hypertension in adults.
Lead Product(s): Sildenafil Citrate
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Revatio-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2023
Lead Product(s) : Sildenafil Citrate
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Granules India Limited Received ANDA Approval for Sildenafil for Oral Suspension
Details : Sildenafil is an inhibitor of cyclic GMP specific PDE type 5, the predominant enzyme metabolizing cyclic GMP in the corpus cavernosum. It is indicated for pulmonary arterial hypertension in adults.
Brand Name : Revatio-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 03, 2023
Details:
Esomeprazole magnesium delayed-release capsules is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.
Lead Product(s): Esomeprazole Magnesium
Therapeutic Area: Gastroenterology Brand Name: Nexium-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2023
Lead Product(s) : Esomeprazole Magnesium
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Granules India Gets USFDA Nod for Generic Drug Used for Short-term Treatment of Heartburn
Details : Esomeprazole magnesium delayed-release capsules is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.
Brand Name : Nexium-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 19, 2023
Details:
Generic of Losartan potassium and hydrochlorothiazide tablets are been approved by FDA, indicated for hypertension to lower blood pressure and to reduce the risk of stroke.
Lead Product(s): Losartan Potassium,Hydrochlorothiazide
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Hyzaar-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2023
Lead Product(s) : Losartan Potassium,Hydrochlorothiazide
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Granules India Limited Received ANDA Approval for Losartan and Hydrochlorothiazide Tablets
Details : Generic of Losartan potassium and hydrochlorothiazide tablets are been approved by FDA, indicated for hypertension to lower blood pressure and to reduce the risk of stroke.
Brand Name : Hyzaar-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 30, 2023
Details:
The company has received approval from the US Food and Drug Administration (USFDA) for generic version for Acetaminophen and Ibuprofen tablets (250 mg/125 mg) indicated for pain and inflammation.
Lead Product(s): Ibuprofen
Therapeutic Area: Neurology Brand Name: Advil-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2023
FDA Approves Granules' OTC Equivalent Of Advil Dual Action Tablets
Details : The company has received approval from the US Food and Drug Administration (USFDA) for generic version for Acetaminophen and Ibuprofen tablets (250 mg/125 mg) indicated for pain and inflammation.
Brand Name : Advil-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 14, 2023
Details:
FDA approved generic of Levetiracetam for seizures. It prevents seizure activity via selective inhibition of hypersynchronized epileptiform burst firing without affecting normal neuronal transmission.
Lead Product(s): Levetiracetam
Therapeutic Area: Neurology Brand Name: Keppra-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2023
Lead Product(s) : Levetiracetam
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Granules India Limited Receives ANDA Approval for Levetiracetam Tablets in record 9 months
Details : FDA approved generic of Levetiracetam for seizures. It prevents seizure activity via selective inhibition of hypersynchronized epileptiform burst firing without affecting normal neuronal transmission.
Brand Name : Keppra-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 14, 2023
Details:
Generic version of Metoprolol Succinate ER Tablets have been approved, these are catecholamines inhibitor indicated for the treatment of hypertension in order to lower blood pressure.
Lead Product(s): Metoprolol Succinate
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Toprol-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2023
Lead Product(s) : Metoprolol Succinate
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Granules India Limited Received ANDA Approval for Metoprolol Succinate ER Tablets
Details : Generic version of Metoprolol Succinate ER Tablets have been approved, these are catecholamines inhibitor indicated for the treatment of hypertension in order to lower blood pressure.
Brand Name : Toprol-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 13, 2023
Details:
Generic version of Venlafaxine HCl extended-release capsules has been approved which are indicated for the treatment of MDD, GAD, SAD and Panic Disorder (PD).
Lead Product(s): Venlafaxine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Effexor-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2023
Lead Product(s) : Venlafaxine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Granules India Limited Received ANDA Approval for Venlafaxine ER Capsules
Details : Generic version of Venlafaxine HCl extended-release capsules has been approved which are indicated for the treatment of MDD, GAD, SAD and Panic Disorder (PD).
Brand Name : Effexor-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 19, 2023
Details:
Gabapentin inhibits the action of alpha-2-delta-1 subunits, thus decreasing the density of pre-synaptic voltage-gated calcium channels and subsequent release of excitatory neurotransmitters. It is indicated for the management of postherpetic neuralgia.
Lead Product(s): Gabapentin
Therapeutic Area: Neurology Brand Name: Neurontin-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2023
Lead Product(s) : Gabapentin
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Granules India Limited Received ANDA Approval for Gabapentin Tablets
Details : Gabapentin inhibits the action of alpha-2-delta-1 subunits, thus decreasing the density of pre-synaptic voltage-gated calcium channels and subsequent release of excitatory neurotransmitters. It is indicated for the management of postherpetic neuralgia.
Brand Name : Neurontin-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 29, 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : No
TE Code :
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : ACETAMINOPHEN
Dosage Strength : 650MG
Approval Date : 2019-04-16
Application Number : 211544
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN, ASPIRIN A...
Dosage Strength : 250MG;250MG;65MG
Approval Date : 2021-02-23
Application Number : 214039
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code : AA
Dosage Form : CAPSULE; ORAL
Proprietary Name : BUTALBITAL AND ACETAMINO...
Dosage Strength : 300MG;50MG
Approval Date : 2019-11-22
Application Number : 213115
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : TABLET; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 325MG;50MG;40MG
Approval Date : 2008-12-01
Application Number : 40864
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : CAPSULE; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 300MG;50MG;40MG
Approval Date : 2020-04-08
Application Number : 213321
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Dosage Form : TABLET; ORAL
Proprietary Name : HYDROCODONE BITARTRATE A...
Dosage Strength : 325MG;5MG
Approval Date : 2020-01-03
Application Number : 211729
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Dosage Form : TABLET; ORAL
Proprietary Name : HYDROCODONE BITARTRATE A...
Dosage Strength : 325MG;7.5MG
Approval Date : 2020-01-03
Application Number : 211729
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Dosage Form : TABLET; ORAL
Proprietary Name : HYDROCODONE BITARTRATE A...
Dosage Strength : 325MG;10MG
Approval Date : 2020-01-03
Application Number : 211729
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND IBUPRO...
Dosage Strength : 250MG;125MG
Approval Date : 2023-07-13
Application Number : 216592
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code : AA
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Proprietary Name : OXYCODONE AND ACETAMINOP...
Dosage Strength : 325MG;2.5MG
Approval Date : 2019-10-31
Application Number : 211708
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
Listed Dossiers
Regulatory Info : ROW, US
Registration Country : India
Dosage Form : Rapid Release Gelcaps
Brand Name :
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : ROW, US
Registration Country : India
Regulatory Info : ROW, US, CA
Registration Country : India
Dosage Form : Extended Release Tablet
Brand Name :
Dosage Strength : 650MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : ROW, US, CA
Registration Country : India
Regulatory Info : ROW, EU
Registration Country : India
Dosage Form : Immediate Release Tablet
Brand Name :
Dosage Strength : 1000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : ROW, EU
Registration Country : India
Regulatory Info : US, UK, EU, ROW, SA
Registration Country : India
Dosage Form : Immediate Release Tablet
Brand Name :
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : US, UK, EU, ROW, SA
Registration Country : India
Regulatory Info : ROW, US
Registration Country : India
Acetaminophen; Aspirin; Caffeine
Dosage Form : Immediate Release Tablet
Brand Name :
Dosage Strength : 50MG; 250MG; 65MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : ROW, US
Registration Country : India
Regulatory Info :
Registration Country : India
Dosage Form : Immediate Release Capsule
Brand Name :
Dosage Strength : 300MG; 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : ROW, US
Registration Country : India
Acetaminophen; Butalbital; Caffeine
Dosage Form : Immediate Release Capsule
Brand Name :
Dosage Strength : 300MG; 50MG; 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : ROW, US
Registration Country : India
Regulatory Info :
Registration Country : India
Dosage Form : Immediate Release Tablet
Brand Name :
Dosage Strength : 500MG; 65MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Dosage Form : Immediate Release Tablet
Brand Name :
Dosage Strength : 250MG; 125MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Dosage Form : Sustained Release Tablet
Brand Name :
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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Granules India Limited is a supplier offers 46 products (APIs, Excipients or Intermediates).
Find a price of Metformin bulk with DMF, CEP, JDMF, WC offered by Granules India Limited
Find a price of Paracetamol bulk with DMF, CEP, JDMF, WC offered by Granules India Limited
Find a price of Cetirizine Dihydrochloride bulk with DMF, CEP, WC offered by Granules India Limited
Find a price of Guaifenesin bulk with DMF, CEP, WC offered by Granules India Limited
Find a price of Metformin bulk with DMF, CEP, WC offered by Granules India Limited
Find a price of Trazodone Hydrochloride bulk with DMF, CEP, WC offered by Granules India Limited
Find a price of Atazanavir Sulfate bulk with DMF, WC offered by Granules India Limited
Find a price of Dimethyl Fumarate bulk with DMF, WC offered by Granules India Limited
Find a price of Eltrombopag bulk with DMF, WC offered by Granules India Limited
Find a price of Fexofenadine Hydrochloride bulk with DMF, WC offered by Granules India Limited
Find a price of Guaifenesin bulk with DMF, CEP offered by Granules India Limited
Find a price of Levocetirizine Dihydrochloride bulk with DMF, WC offered by Granules India Limited
Find a price of Losartan Potassium bulk with DMF, WC offered by Granules India Limited
Find a price of Metformin bulk with CEP, WC offered by Granules India Limited
Find a price of Methocarbamol bulk with DMF, WC offered by Granules India Limited
Find a price of Metoprolol Succinate bulk with DMF, WC offered by Granules India Limited
Find a price of Omeprazole Magnesium bulk with DMF, WC offered by Granules India Limited
Find a price of Pirfenidone bulk with DMF, WC offered by Granules India Limited
Find a price of Rifaximin bulk with DMF, WC offered by Granules India Limited
Find a price of Bupropion Hydrochloride bulk with DMF offered by Granules India Limited
Find a price of Dapagliflozin bulk with DMF offered by Granules India Limited
Find a price of Dasatinib bulk with DMF offered by Granules India Limited
Find a price of Empagliflozin bulk with DMF offered by Granules India Limited
Find a price of Esomeprazole Magnesium bulk with DMF offered by Granules India Limited
Find a price of Gabapentin bulk with WC offered by Granules India Limited
Find a price of Lapatinib Ditosylate bulk with DMF offered by Granules India Limited
Find a price of Levetiracetam bulk with DMF offered by Granules India Limited
Find a price of Linagliptin bulk with DMF offered by Granules India Limited
Find a price of Losartan Potassium bulk with DMF offered by Granules India Limited
Find a price of Metoprolol Succinate bulk with DMF offered by Granules India Limited
Find a price of Nilotinib bulk with DMF offered by Granules India Limited
Find a price of Omeprazole bulk with DMF offered by Granules India Limited
Find a price of Pantoprazole Sodium bulk with DMF offered by Granules India Limited
Find a price of Paracetamol bulk with DMF offered by Granules India Limited
Find a price of Pazopanib Hydrochloride bulk with DMF offered by Granules India Limited
Find a price of Prazosin Hydrochloride bulk with DMF offered by Granules India Limited
Find a price of Rifaximin bulk with DMF offered by Granules India Limited
Find a price of Sorafenib bulk with DMF offered by Granules India Limited
Find a price of Tenofovir Disoproxil Succinate bulk with WC offered by Granules India Limited
Find a price of Vigabatrin bulk with DMF offered by Granules India Limited
Find a price of Avatrombopag Maleate bulk offered by Granules India Limited
Find a price of Cabozantinib bulk offered by Granules India Limited
Find a price of Elacestrant bulk offered by Granules India Limited
Find a price of Ruxolitinib Phosphate bulk offered by Granules India Limited
Find a price of Sitagliptin Phosphate bulk offered by Granules India Limited
Find a price of Tenofovir Alafenamide Fumarate bulk offered by Granules India Limited
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
