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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
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CORPORATE CONTENT #SupplierSpotlight
NEWS #PharmaBuzz
01 Jan 2025
// BUSINESS STD
04 Dec 2024
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25 Nov 2024
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25 Nov 2024
// PRESS RELEASE
21 Nov 2024
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21 Nov 2024
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Drugs in Development
Lead Product(s) : Fluoxetine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Pharma Subsidiary Receives USFDA Approval for 60 mg Fluoxetine Tablets
Details : Fluoxetine hydrochloride, is an antidepressant of the SSRIs class. It is used for the treatment of major depressive disorder, obsessive–compulsive disorder, bulimia nervosa, etc.
Brand Name : Fluoxetine HCl-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 18, 2024
Lead Product(s) : Theophylline
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Gets USFDA Nod for Theophylline Extended-Release Tablets
Details : Theophylline extended-release tablets formulation approved for the use in the treatment of asthma and chronic obstructive pulmonary disease.
Brand Name : Theo-Dur-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 07, 2024
Lead Product(s) : Sucralfate
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides receives USFDA approval for Sucralfate Oral Suspension, 1gm/10 mL
Details : Carafate-generic (sucralfate) is a USFDA approved pepsin A inhibitor small molecule drug candidate, which is indicated for the treatment of active duodenal ulcer.
Brand Name : Carafate-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 23, 2024
Lead Product(s) : Sevelamer Hydrochloride
Therapeutic Area : Nephrology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Receives USFDA Approval for Sevelamer Carbonate Tablets
Details : USFDA approved generic version of Sevelamer Carbonate which is used to manage elevated levels of phosphate in the blood of patients with chronic kidney disease.
Brand Name : Renvela-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 10, 2024
Lead Product(s) : Fluoxetine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Pharma Gets USFDA Nod for Antidepressant Medication
Details : Fluoxetine hydrochloride (Prozac) is an SSRI antidepressant used for major depressive disorder, OCD, bulimia, and panic disorder.
Brand Name : Prozac-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 08, 2024
Lead Product(s) : Gabapentin
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Receives USFDA Approval for Gabapentin Tablets USP, 600 mg and 800 mg
Details : USFDA approved generic version of Gabapentin tablet, which is an anticonvulsant medication primarily used to treat partial seizures and neuropathic pain.
Brand Name : Neurontin-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 05, 2024
Lead Product(s) : Pregabalin
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Receives USFDA Approval for Pregabalin Capsules
Details : USFDA approved generic version of Pregabalin treatment of fibromyalgia. It binds to the alpha2-delta subunit which is involved in anti-nociceptive and antiseizure effects.
Brand Name : Lyrica-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 25, 2024
Lead Product(s) : Icosapent Ethyl
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Amneal Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Launches Icosapent Ethyl Acid Soft Gel Capsules in Partnership with Amneal
Details : Vascepa-Generic (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.
Brand Name : Vascepa-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 02, 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
Strides Receives USFDA Approval for Levetiracetam Oral Solution
Details : USFDA approved generic version of Levetiracetam for the treatment of seizures. It prevents seizure activity via the selective inhibition of hypersynchronized epileptiform burst firing without affecting normal neuronal transmission.
Brand Name : Keppra-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 21, 2023
Lead Product(s) : Efavirenz,Emtricitabine,Tenofovir Disproxil Fumurate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Efavirenz/ Emtricitabine/tenofovir disoproxil fumarate) tablets a combination of 2 nucleoside analog HIV-1 reverse transcriptase inhibitors and 1 non-nucleoside HIV-1 reverse transcriptase inhibitor, for the treatment of HIV-1 infection.
Brand Name : Atripla-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 04, 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info :
Registration Country : India
Dosage Form : Tablet
Brand Name :
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Dosage Form : Tablet
Brand Name :
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ACARBOSE
Dosage Strength : 25MG
Packaging :
Approval Date : 2011-07-27
Application Number : 90912
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ACARBOSE
Dosage Strength : 100MG
Packaging :
Approval Date : 2011-07-27
Application Number : 90912
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : India
Dosage Form : Tablet
Brand Name :
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ACARBOSE
Dosage Strength : 50MG
Packaging :
Approval Date : 2011-07-27
Application Number : 90912
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : India
Dosage Form : Tablet
Brand Name :
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : TABLET;ORAL
Brand Name : BUTALBITAL, ACETAMINOPHEN...
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 2020-09-21
Application Number : 203647
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : TABLET;ORAL
Brand Name : BUTALBITAL, ACETAMINOPHEN...
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 2003-08-27
Application Number : 40511
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Dosage Form : CAPSULE;ORAL
Brand Name : BUTALBITAL, ACETAMINOPHEN...
Dosage Strength : 325MG;50MG;40MG;30MG
Packaging :
Approval Date : 2020-07-08
Application Number : 204649
Regulatory Info : RX
Registration Country : USA
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 : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACARBOSE
Dosage Strength : 25MG
Approval Date : 2011-07-27
Application Number : 90912
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACARBOSE
Dosage Strength : 50MG
Approval Date : 2011-07-27
Application Number : 90912
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACARBOSE
Dosage Strength : 100MG
Approval Date : 2011-07-27
Application Number : 90912
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : TABLET; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 325MG;50MG;40MG
Approval Date : 2003-08-27
Application Number : 40511
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 : 2020-09-21
Application Number : 203647
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AB
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Dosage Form : CAPSULE; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 325MG;50MG;40MG;30MG
Approval Date : 2020-07-08
Application Number : 204649
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : SOLUTION; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 120MG/5ML;12MG/5ML
Approval Date : 1982-01-01
Application Number : 86366
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AA
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 300MG;30MG
Approval Date : 1988-09-30
Application Number : 89805
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 300MG;60MG
Approval Date : 1988-09-30
Application Number : 89828
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 300MG;15MG
Approval Date : 1988-09-30
Application Number : 89990
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
Europe
Regulatory Info :
Registration Country : Norway
Dosage Form : Kapsel, myk
Dosage Strength : 250 mg
Packaging : Boks av plast 1...
Brand Name : Ethosuximide Strides
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride
Dosage Form : Powder for oral solution, solu...
Dosage Strength :
Packaging : Dosepose 100ite...
Brand Name : Macrovic
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KEY PRODUCTS
TOP RANKED SUPPLIER FOR:
FDA
District Decision : No Action Indicated
Inspection End Date : 2022-08-08
City : Singapore
State :
Country/Area : SG
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2022-08-08
District Decision : No Action Indicated
Inspection End Date : 2019-08-23
City : Chestnut Ridge
State :
Country/Area : US
Zip :
District :
Center :
Project Area : Bioresearch Monitoring
District Decision : No Action Indicated
Inspection End Date : 2019-08-23
District Decision : Voluntary Action Indicated
Inspection End Date : 2020-01-17
City : Bangalore
State :
Country/Area : IN
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2020-01-17
District Decision : No Action Indicated
Inspection End Date : 2020-03-05
City : Bangalore
State :
Country/Area : IN
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2020-03-05
District Decision : Voluntary Action Indicated
Inspection End Date : 2022-02-08
City : Chestnut Ridge
State :
Country/Area : US
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2022-02-08
District Decision : Voluntary Action Indicated
Inspection End Date : 2022-12-09
City : Bangalore
State :
Country/Area : IN
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2022-12-09
District Decision : Voluntary Action Indicated
Inspection End Date : 2023-02-24
City : Puducherry
State :
Country/Area : IN
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2023-02-24
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-03-16
City : Chestnut Ridge
State :
Country/Area : US
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-03-16
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-05-26
City : Bangalore
State :
Country/Area : IN
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-05-26
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-05-15
City : Milano
State :
Country/Area : IT
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-05-15
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]WHO-GMP
Name and address of WHO GMP certified Manufacturer : M/s. Strides Arcolab Ltd., No.36/7, Suragajakkanahalli, Indalvadi Cross, Anekal Taluk, Bangalore Dist -562106
Country : India
Name and address of WHO GMP certified Manufacturer : STRIDES ARCOLAB LTD PLOT NO.9-12 DEWAN AND SONS IND AREA,,VEOOR,PALGHAR THANE 401404
Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]GDUFA
API Manufacturer :
FDF Manufacturer :
Facility Name : Strides Pharma Science
Business Address : R.S.No 33 and 34, Mathur Roa...
FEI Number : 3002808058
Country : India
Paid in : 2018
API Manufacturer :
FDF Manufacturer :
Facility Name : Strides Pharma Science
Business Address : A1/B, Sipcot Industrial Comp...
FEI Number : 3003585876
Country : India
Paid in : 2018
API Manufacturer :
FDF Manufacturer :
Facility Name : Strides Pharma Science
Business Address : 3, Tuas South Avenue 4 Singa...
FEI Number : 3012423830
Country : India
Paid in : 2022
API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Strides Pharma Science
Business Address : 1 Ram Ridge Rd Chestnut Ridg...
FEI Number : 002434223
Country : India
Paid in : 2024
API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Strides Pharma Science Limited
Business Address : No 36/7, Suragajakkanahalli,...
FEI Number : 3004554612
Country : India
Paid in : 2024
API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Strides Pharma Science Limited
Business Address : R. S. No. 32, 33/11 and 34/2...
FEI Number : 3012448465
Country : India
Paid in : 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
