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    [{"orgOrder":0,"company":"Granules India Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Granules India Limited Announces USFDA Approval of Metformin Hydrochloride ER Tablets USP, 500 mg and 1000 mg","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Granules India Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Granules India Limited Announces Approval of Acetaminophen, Aspirin and Caffeine Tablets","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Granules India Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Granules Pharmaceuticals Inc., Receives ANDA Approval for Amphetamine Mixed Salts ER Capsules","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Granules India Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Granules Gets USFDA Nod to Market Generic Medication to Treat High Blood Pressure","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Granules India Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Granules India Limited Received ANDA Approval for Gabapentin Tablets","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Granules India Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Granules India Limited Announces Tentative Approval of Colchicine Capsules, 0.6 mg, Generic Equivalent of Mitigare\u00ae Capsules, 0.6mg of Hikma International Pharmaceuticals LLC.","therapeuticArea":"Rheumatology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Rheumatology","graph2":"Approved"},{"orgOrder":0,"company":"Granules India Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Granules India Limited Receives Approval from US Food & Drug Administration (US FDA) of Colchicine Tablets used for the treatment of Familial Mediterranean Fever (FMF).","therapeuticArea":"Rheumatology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Rheumatology","graph2":"Approved"},{"orgOrder":0,"company":"Granules India Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Granules India Gets USFDA Nod for Generic Drug Used for Short-term Treatment of Heartburn","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"}]

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              Granules India Limited

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              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.

              Lead Product(s): Esomeprazole Magnesium

              Therapeutic Area: Gastroenterology Product Name: Nexium-Generic

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 19, 2023

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              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.

              Lead Product(s): Gabapentin

              Therapeutic Area: Neurology Product Name: Neurontin-Generic

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 29, 2023

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              Granules India Limited

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              Granules Gets USFDA Nod to Market Generic Medication to Treat High Blood Pressure

              Details:

              Losartan potassium prevention of angiotensin II binding causes vascular smooth muscle relaxation, lowering blood pressure. Angiotensin II would otherwise bind to the AT1 receptor and induce vasoconstriction, raising blood pressure.

              Lead Product(s): Losartan Potassium

              Therapeutic Area: Cardiology/Vascular Diseases Product Name: Losartan Potassium-Generic

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 27, 2023

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              Granules Pharmaceuticals Inc., Receives ANDA Approval for Amphetamine Mixed Salts ER Capsules

              Details:

              Dextroamphetamine Sulfate is a non-catecholamine sympathomimetic amines with CNS stimulant activity. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

              Lead Product(s): Amphetamine,Dextroamphetamine Saccharate,Amphetamine Aspartate

              Therapeutic Area: Psychiatry/Psychology Product Name: Amphetamine-Generic

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 24, 2023

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              Granules India Limited Announces Approval of Acetaminophen, Aspirin and Caffeine Tablets

              Details:

              The US Food & Drug Administration (US FDA) has approved Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC).

              Lead Product(s): Paracetamol,Aspirin,Caffeine

              Therapeutic Area: Neurology Product Name: Acetaminophen/Aspirin/Caffeine-Generic

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 24, 2021

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              Granules India Limited Announces USFDA Approval of Metformin Hydrochloride ER Tablets USP, 500 mg and 1000 mg

              Details:

              Granules India has been granted final FDA approval for its Abbreviated New Drug Application (ANDA) for Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg, generic equivalent of Glumetza ER Tablets, 500 mg and 1000 mg, of Bausch Health US LLC (Bausch).

              Lead Product(s): Metformin

              Therapeutic Area: Endocrinology Product Name: Undisclosed

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 13, 2021

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              Granules India Limited Announces Tentative Approval of Colchicine Capsules, 0.6 mg, Generic Equivalent of Mitigare® Capsules, 0.6mg of Hikma International Pharmaceuticals ...

              Details:

              Colchicine capsules inhibits the beta tubulin polymerisation into microtubules, which is indicated for the prophylaxis of gout flares in adults patients.

              Lead Product(s): Colchicine

              Therapeutic Area: Rheumatology Product Name: Mitigare-Generic

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 11, 2020

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              Granules India Limited Receives Approval from US Food & Drug Administration (US FDA) of Colchicine Tablets used for the treatment of Familial Mediterranean Fever (FMF).

              Details:

              Colchicine tablets inhibits the beta tubulin polymerisation, which is indicated for prophylaxis of gout flares in adults and Familial Mediterranean fever (FMF) in adults and children 4 years or older

              Lead Product(s): Colchicine

              Therapeutic Area: Rheumatology Product Name: Colcrys-Generic

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 06, 2020

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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