MedPath

ALEMBIC PHARMACEUTICALS

🇮🇳India
Ownership
-
Employees
-
Market Cap
$2.4B
Website

Clinical Trials

6

Active:0
Completed:3

Trial Phases

2 Phases

Phase 1:3
Not Applicable:2

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (5 trials with phase data)• Click on a phase to view related trials

Phase 1
3 (60.0%)
Not Applicable
2 (40.0%)

Single Dose Crossover Comparative Bioavailability Study of Bupropion Hcl MR Tablet 300mg

Phase 1
Completed
Conditions
Bioequivalence
Interventions
First Posted Date
2021-12-16
Last Posted Date
2022-05-09
Lead Sponsor
Alembic Pharmaceuticals Ltd.
Target Recruit Count
34
Registration Number
NCT05160090
Locations
🇨🇦

Algorithme Pharma, Mount Royal, Quebec, Canada

🇨🇦

Algorithme Pharma Inc., Mount-Royal, Quebec, Canada

Oral Bio-equivalence Study

Phase 1
Completed
Conditions
Safety
Bioequivalence
Interventions
First Posted Date
2021-12-06
Last Posted Date
2021-12-21
Lead Sponsor
Alembic Pharmaceuticals Ltd.
Target Recruit Count
26
Registration Number
NCT05145621
Locations
🇨🇦

Algorithme Pharma Inc., Mount-Royal, Quebec, Canada

Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg

Phase 1
Completed
Conditions
Bioequivalence
Interventions
First Posted Date
2021-12-06
Last Posted Date
2021-12-07
Lead Sponsor
Alembic Pharmaceuticals Ltd.
Target Recruit Count
22
Registration Number
NCT05145608
Locations
🇨🇦

Algorithme Pharma, Mount Royal, Quebec, Canada

News

Alembic Pharmaceuticals Receives FDA Approval for Generic Tretinoin Cream to Treat Acne Vulgaris

Alembic Pharmaceuticals has received final FDA approval for its generic Tretinoin Cream USP (0.025%) to treat acne vulgaris in the US market.

Alembic Pharmaceuticals Acquires UTILITY Therapeutics to Commercialize First New UTI Antibiotic in 20 Years

Alembic Pharmaceuticals has acquired UTILITY Therapeutics to expand its U.S. commercial portfolio with PIVYA, the first antibiotic approved for uncomplicated urinary tract infections in approximately 20 years.

Alembic Pharmaceuticals Receives FDA Approval for Generic Ticagrelor Tablets to Reduce Cardiovascular Risks

Alembic Pharmaceuticals has secured final FDA approval for Ticagrelor Tablets 90 mg and tentative approval for the 60 mg version, a generic equivalent to AstraZeneca's Brilinta.

Alembic Pharma Shares Surge Following USFDA Clearance of Panelav Oncology Facility

Alembic Pharmaceuticals received an Establishment Inspection Report (EIR) from the USFDA for its Panelav oncology formulation facility following a clean inspection conducted from October 7-8, 2024.

FDA Approves 25 First-Time Generic Drugs in First Half of 2025, Expanding Access to Critical Therapies

The FDA approved 25 first-time generic drugs in the first six months of 2025, including generics for critical medications treating HIV, cancer, and neurological conditions.

Alembic Pharmaceuticals Secures USFDA Approvals for Carbamazepine and Amlodipine-Atorvastatin Generics

Alembic Pharmaceuticals has received final USFDA approval for generic Carbamazepine 200 mg tablets, an anticonvulsant used for seizure disorders and neuropathic pain with a US market size of approximately $32 million.

Alembic Pharmaceuticals Receives FDA Approval for Pantoprazole Sodium Injection to Treat GERD

Alembic Pharmaceuticals has secured final USFDA approval for Pantoprazole Sodium for Injection (40 mg/vial), therapeutically equivalent to Wyeth's Protonix I.V. for Injection.

Allchem Lifescience Files for IPO to Raise ₹190 Crore, Expands API Manufacturing Capabilities

Gujarat-based Allchem Lifescience has filed preliminary IPO papers with SEBI, seeking to raise ₹190 crore through fresh equity shares and an offer for sale of 71.55 lakh shares by promoters.

Alembic Pharmaceuticals Receives US FDA Approval for Diltiazem Hydrochloride Extended-Release Capsules

Alembic Pharmaceuticals has secured US FDA approval for Diltiazem Hydrochloride extended-release capsules (120 mg, 180 mg, 240 mg, 300 mg, and 360 mg).

Alembic Pharmaceuticals Receives USFDA Approval for Generic Hypertension Treatment

Alembic Pharmaceuticals has secured USFDA approval for its generic Diltiazem Hydrochloride extended-release capsules, used to treat hypertension.

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