27 Jan 2025
// PRESS RELEASE
22 Feb 2025
// INDPHARMAPOST
30 Jan 2025
// PRESS RELEASE
27 Jan 2025
// PRESS RELEASE
22 Feb 2025
// INDPHARMAPOST
Latest Content by PharmaCompass
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
About
Products listed herein may not be available for commercial use in countries where any relevant third-party intellectual property is in force.
Industry Trade Show
Attending
09-11 April, 2025
Industry Trade Show
Attending
24-26 June, 2025
CPhI WW FrankfurtCPhI WW Frankfurt
Industry Trade Show
Booth #9.1A48
28-30 October, 2025
CONTACT DETAILS
Events
Webinars & Exhibitions
Industry Trade Show
Attending
09-11 April, 2025
Industry Trade Show
Attending
24-26 June, 2025
CPhI WW FrankfurtCPhI WW Frankfurt
Industry Trade Show
Booth #9.1A48
28-30 October, 2025
CORPORATE CONTENT #SupplierSpotlight
https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions
22 Feb 2025
// INDPHARMAPOST
https://www.indianpharmapost.com/news/granules-india-acquires-swiss-senn-chemicals-to-foray-into-peptide-and-cdmo-business-16813
30 Jan 2025
// PRESS RELEASE
https://granulesindia.com/wp-content/uploads/2025/01/Granules-Strengthens-ADHD-Portfolio-with-FDA-Approval-for-Lisdexamfetamine-Dimesylate-Capsules.pdf
27 Jan 2025
// PRESS RELEASE
https://granulesindia.com/wp-content/uploads/2025/01/Press-Release-Q3-FY25.pdf
29 Dec 2024
// BUSINESS STD
https://www.business-standard.com/companies/news/granules-india-expects-fda-nod-for-drug-from-gagillapur-facility-by-fy26-124122900434_1.html
17 Dec 2024
// PRESS RELEASE
https://granulesindia.com/wp-content/uploads/2024/12/Granules-India-Limited-Announces-FDA-Approval-for-ADHD-Treatment-Addressing-Drug-Shortages-in-the-U.S.pdf
16 Dec 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219258
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-08
Pay. Date : 2012-11-29
DMF Number : 19804
Submission : 2006-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32259
Submission : 2017-12-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-27
Pay. Date : 2021-04-15
DMF Number : 35694
Submission : 2021-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-23
Pay. Date : 2015-12-14
DMF Number : 30063
Submission : 2016-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20998
Submission : 2007-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20606
Submission : 2007-06-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35886
Submission : 2021-05-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36088
Submission : 2021-07-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17723
Submission : 2004-09-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19972
Submission : 2006-11-16
Status : Active
Type : II
Regulatory Info : OTC
Registration Country : USA
Dosage Form : TABLET, EXTENDED RELEASE...
Brand Name : ACETAMINOPHEN
Dosage Strength : 650MG
Packaging :
Approval Date : 2019-04-16
Application Number : 211544
Regulatory Info : OTC
Registration Country : USA
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 : 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 :
Registration Country : Canada
Dosage Form : TABLET (EXTENDED-RELEASE...
Brand Name : ARTHRITIS PAIN RELIEF
Dosage Strength : 650MG
Packaging :
Approval Date :
Application Number : 2519631
Regulatory Info :
Registration Country : Canada
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, 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 : OTC
Registration Country : USA
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Dosage Form : TABLET;ORAL
Brand Name : ACETAMINOPHEN, ASPIRIN AN...
Dosage Strength : 250MG;250MG;65MG
Packaging :
Approval Date : 2021-02-23
Application Number : 214039
Regulatory Info : OTC
Registration Country : USA
Regulatory Info : ROW, US
Registration Country : India
Acetaminophen; Aspirin; Caffeine
Dosage Form : Immediate Release Tablet
Brand Name :
Dosage Strength : 250MG; 250MG; 65MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : ROW, US
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : BUTALBITAL AND ACETAMINOP...
Dosage Strength : 300MG;50MG
Packaging :
Approval Date : 2019-11-22
Application Number : 213115
Regulatory Info : RX
Registration Country : USA
Regulatory Info : ROW, US
Registration Country : India
Dosage Form : Immediate Release Capsul...
Brand Name :
Dosage Strength : 300MG; 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : ROW, US
Registration Country : India
Inspections and registrations
District Decision : No Action Indicated
Inspection End Date : 2015-03-13
City : Qutbullapur Mandal, Ranga...
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2015-03-13
District Decision : No Action Indicated
Inspection End Date : 2014-06-13
City : Bonthapally, Medak Distri...
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-06-13
District Decision : No Action Indicated
Inspection End Date : 2013-06-14
City : Visakhapatnam
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2013-06-14
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-05-08
City : Hyderabad
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-05-08
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-09-13
City : Qutbullapur Mandal, Ranga...
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-09-13
District Decision : No Action Indicated
Inspection End Date : 2010-11-22
City : Bonthapally, Medak Distri...
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2010-11-22
District Decision : No Action Indicated
Inspection End Date : 2009-11-12
City : Qutbullapur Mandal, Ranga...
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2009-11-12
District Decision : Voluntary Action Indicated
Inspection End Date : 2009-03-06
City : Hyderabad
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2009-03-06
Type : GMP Certificates
Number : FT022/MH/00...
EudraGMDP Key : 40343
Country : India
Issue Date : 2017-02-24
Post Code : 500043
NCA Ref : FT022
City : Ranga Reddy District
Type : GMP Certificates
Number : FT052/S1/MH...
EudraGMDP Key : 31856
Country : India
Issue Date : 2015-10-26
Post Code : 500 055
NCA Ref : 104621298632...
City : Hyderabad
Type : GMP Certificates
Number : HMP/PT/221/...
EudraGMDP Key : 28131
Country : India
Issue Date : 2014-11-19
Post Code : 500055
NCA Ref : A0372917466
City : HYDERABAD, ANDHRA PRADE...
Type : GMP Certificates
Number : FI21/01/201...
EudraGMDP Key : 25980
Country : India
Issue Date : 2014-10-27
Post Code : 502313
NCA Ref : 104721298997...
City : Medak District
Type : GMP Certificates
Number : FI22/01/201...
EudraGMDP Key : 21875
Country : India
Issue Date : 2013-12-16
Post Code : 500 043
NCA Ref : 104621298630...
City : Quthbullapur Mandal, Ra...
Type : GMP Certificates
Number : FI21/01/201...
EudraGMDP Key : 21874
Country : India
Issue Date : 2013-12-16
Post Code : 502313
NCA Ref : 1.04721299e+...
City : Medak District
ABOUT THIS PAGE
Granules India Limited is a supplier offers 44 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 Atazanavir Sulfate bulk with DMF, CEP, 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 Losartan Potassium 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 Metoprolol Succinate bulk with DMF, CEP, WC offered by Granules India Limited
Find a price of Pirfenidone bulk with DMF, CEP, WC offered by Granules India Limited
Find a price of Rifaximin 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 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 Esomeprazole Magnesium bulk with DMF, CEP offered by Granules India Limited
Find a price of Fexofenadine Hydrochloride bulk with DMF, WC offered by Granules India Limited
Find a price of Levetiracetam 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 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 Omeprazole bulk with DMF, CEP offered by Granules India Limited
Find a price of Omeprazole Magnesium bulk with DMF, WC offered by Granules India Limited
Find a price of Pantoprazole Sodium bulk with DMF, CEP offered by Granules India Limited
Find a price of Rifaximin bulk with DMF, CEP offered by Granules India Limited
Find a price of Sorafenib bulk with DMF, CEP 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
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Find a price of Lapatinib Ditosylate 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
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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 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
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Find a price of Elacestrant bulk offered by Granules India Limited