At Medicap Labs, we specialize in new product development and generic ANDA formulations, delivering innovative solutions across multiple therapeutic areas. Our portfolio combines scientific expertise and regulatory compliance to accelerate development from concept to market. We focus on creating safe, effective, and commercially viable pharmaceutical products.

ANDA Products

Our Hypermatrix technology allows for the intelligent and efficient design of drugs through the precise manipulation of a number of key variables. This allows us to respond to varying drug attributes and patient requirements, producing a desired controlled-release effect in a time and cost effective manner. Our pipeline of complex extended-release generic products are specifically targeted for launch into high need markets.

Product Pipeline Status

Approved
In Progress
Product Dosage Form Strength Indication
Clinical/ BE Studies FDA Filed FDA Approved

ANDA Portfolio

Dexmethylphenidate Hydrochloride ER
Capsule, Extended Release 5mg, 10 mg, 15mg, 20mg, 30mg, 40mg ADHD
Metformin Hydrochloride ER
Tablet, Extended Release 500mg, 750 mg Diabetes
Venlafaxine Hydrochloride ER
Capsule, Extended Release 37.5, 75mg, 150mg Depression
Quetiapine Fumarate ER
Tablet, Extended Release 50mg, 150mg, 200mg, 300mg, 400mg Schizophrenia
Desvenlafaxine Succinate ER
Tablet, Extended Release 50mg, 100mg Depression
Pantoprazole Sodium Sesquihydrate DR
Tablets, Delayed-Release  20mg and 40 mg GERD
Lamotrigine ER
Tablet, Extended Release 25mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg Epilepsy
 Levetiracetam ER
Tablet, Extended Release 500mg, 750mg Epilepsy
Ranolazine ER
Tablet, Extended Release  500 mg and 1000 mg Chronic Angina
Trazodone Hydrochloride ER
Tablet, Extended Release  150mg and 300 mg Heart failure, Hypertension

ANDA Portfolio

Dexmethylphenidate Hydrochloride ER
Dosage Form Capsule, Extended Release
Strength 5mg, 10 mg, 15mg, 20mg, 30mg, 40mg

ADHD

Metformin Hydrochloride ER
Dosage Form Tablet, Extended Release
Strength 500mg, 750 mg

Diabetes

Venlafaxine Hydrochloride ER
Dosage Form Capsule, Extended Release
Strength 37.5, 75mg, 150mg

Depression

Quetiapine Fumarate ER
Dosage Form Tablet, Extended Release
Strength 50mg, 150mg, 200mg, 300mg, 400mg

Schizophrenia

Desvenlafaxine Succinate ER
Dosage Form Tablet, Extended Release
Strength 50mg, 100mg

Depression

Pantoprazole Sodium Sesquihydrate DR
Dosage Form Tablets, Delayed-Release
Strength  20mg and 40 mg

GERD

Lamotrigine ER
Dosage Form Tablet, Extended Release
Strength 25mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg

Epilepsy

 Levetiracetam ER
Dosage Form Tablet, Extended Release
Strength 500mg, 750mg

Epilepsy

Ranolazine ER
Dosage Form Tablet, Extended Release
Strength  500 mg and 1000 mg

Chronic Angina

Trazodone Hydrochloride ER
Dosage Form Tablet, Extended Release
Strength  150mg and 300 mg

Heart failure, Hypertension

Interested in exploring how we can meet your development needs? Reach out to our team to discuss your API, target release profile, and regulatory strategy.

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