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.
• The medication is indicated to reduce the risk of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or history of MI, with additional indications for stent thrombosis prevention.
• The estimated market size for Ticagrelor Tablets is substantial, with the 90 mg version valued at $1.06 billion and the 60 mg version at $242 million for the twelve months ending March 2025.
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.
• The company specializes in manufacturing API intermediates and piperazine derivatives critical for drugs like quetiapine, with ₹130 crore of proceeds earmarked for debt repayment.
• Allchem has demonstrated strong financial growth with revenue CAGR of 12.75% and profit CAGR of 28.65% between FY22-24, serving 214 customers across 22 countries globally.
Lupin Launches Generic Rivaroxaban in US Market Following FDA Approval
• Lupin has launched Rivaroxaban Tablets USP, 2.5 mg in the US market after receiving final approval from the FDA for its Abbreviated New Drug Application.
• The generic equivalent of Janssen's Xarelto® targets patients with coronary artery disease and peripheral artery disease, with estimated annual US sales of $446 million.
• This strategic launch strengthens Lupin's position in the high-value anticoagulant market, following the company's strong Q3 performance with a 38.8% increase in profit.
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).
• These capsules are indicated for the treatment of hypertension, and may be used alone or in combination with other antihypertensive medications.
• The approved ANDA is therapeutically equivalent to Cardizem CD extended-release capsules, offering a generic alternative for patients.
• The estimated market size for Diltiazem Hydrochloride extended-release capsules is $105.3 million for the twelve months ending June 2024, according to IQVIA.
Alembic Pharmaceuticals Receives USFDA Approval for Diltiazem Hydrochloride Extended-Release Capsules
• Alembic Pharmaceuticals secured USFDA approval for Diltiazem Hydrochloride Extended-Release Capsules (120-360 mg).
• The drug is therapeutically equivalent to Cardizem CD, used for hypertension and chronic stable angina.
• The market size for Diltiazem Hydrochloride Extended-Release Capsules is estimated at $105.3 million.
• Alembic now has 218 ANDA approvals, including 191 final and 27 tentative approvals.
Alembic Pharma Receives USFDA Approval for Generic Hypertension Drug
• Alembic Pharmaceuticals has secured USFDA approval for Diltiazem Hydrochloride Extended-Release capsules, a generic alternative to Cardizem CD.
• The approved capsules, available in multiple dosages, are indicated for treating hypertension and angina.
• The market for Diltiazem Hydrochloride Extended-Release Capsules is estimated at $105.3 million in the U.S.
• This approval strengthens Alembic Pharma's generics portfolio in the U.S., bringing their total ANDA approvals to 218.
Alembic Pharma Gains US FDA Approval for Generic Lamotrigine Extended-Release Tablets
• Alembic Pharmaceuticals receives US FDA final approval for Lamotrigine Extended-Release Tablets USP (200 mg, 250 mg, and 300 mg).
• The approved ANDA is therapeutically equivalent to GlaxoSmithKline's Lamictal XR, used to treat certain types of seizures.
• Lamotrigine extended-release tablets are indicated for adjunctive therapy and monotherapy conversion in epilepsy patients 13 years and older.
• The estimated market size for Lamotrigine Extended-Release Tablets is $163 million for the twelve months ending June 2024, according to IQVIA.
Alembic and Zydus Secure USFDA Approvals for Paliperidone and Diltiazem Generics
• Alembic Pharmaceuticals gains USFDA approval for Paliperidone Extended-Release Tablets, a generic version of Invega, used in treating schizophrenia and schizoaffective disorder.
• Zydus Lifesciences receives USFDA approval for its generic Paliperidone extended-release tablets, indicated for schizophrenia and schizoaffective disorder treatments.
• Alembic Pharma also secures USFDA approval for Diltiazem Hydrochloride Extended-Release Capsules, a generic equivalent to Dilacor XR, used for hypertension and chronic stable angina.
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