Alembic Pharmaceuticals USFDA approvals lift ANDA tally

What Alembic announced to exchanges

Alembic Pharmaceuticals has reported fresh regulatory milestones in the US, led by an approval for a cardiovascular drug and a separate green light for an oncology product update. The company said it received tentative approval from the US Food and Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) for Bosutinib Tablets, 400 mg. Separately, Alembic said it has received final approval from the USFDA for an Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Tablets USP. The Diltiazem approval covers multiple strengths and is used in the treatment of high blood pressure and angina. Together, the updates add to a long list of US approvals that are closely watched by Indian pharma investors because the US remains a key market for generics.

Diltiazem tablets: strengths and therapeutic equivalence

The approved product is Diltiazem Hydrochloride Tablets USP in 30 mg, 60 mg, 90 mg, and 120 mg strengths. Alembic said these tablets are prescribed for treating high blood pressure and angina, a type of chest pain. The company also stated that the approved ANDA is considered therapeutically equivalent to Cardizem Tablets. Cardizem Tablets are the reference listed drug (RLD) manufactured by Bausch Health US, LLC. Therapeutic equivalence is important for generic substitution in the US, and it typically supports faster market uptake once the product is launched, subject to commercial decisions that the company did not detail in the provided text.

Bosutinib 400 mg: tentative approval under a supplemental filing

Alembic said it received tentative approval for its supplemental ANDA for Bosutinib Tablets, 400 mg. The filing is described as an sANDA, which indicates a supplemental application linked to an existing ANDA pathway. The update is framed as a regulatory milestone, although the text does not provide launch timing or commercial scale. The headline reference to Bosutinib positions the development within an oncology context, and the approval status is specifically tentative rather than final. Investors generally track tentative approvals because they can convert into final approvals after pending conditions are resolved.

Where Alembic’s USFDA approval count stands

Alembic said the Diltiazem Hydrochloride Tablets USP approval marks its 230th ANDA approval from the USFDA. The company further broke this cumulative number down as 210 final approvals and 20 tentative approvals. This tally is significant because it signals a steady pipeline of filings moving through the US regulator. It also provides a simple benchmark for how frequently the company is clearing regulatory milestones. The text includes a separate statement elsewhere that Alembic “now has a cumulative total of 211 ANDA approvals from the USFDA,” which appears in a different approval context, indicating that the cumulative count has been cited at different levels across different updates.

Other US approvals cited across Alembic filings

Beyond Diltiazem tablets and Bosutinib, the provided material references multiple other approvals that Alembic has announced. Alembic said Dabigatran Etexilate Capsules are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery, and that its approved product is therapeutically equivalent to Boehringer Ingelheim Pharmaceuticals Inc’s Pradaxa Capsules (110 mg). In another filing, Alembic said it received final approval for Divalproex Sodium delayed-release capsules of strength 125 mg, used in the treatment of epilepsy. Alembic stated that this approved ANDA is therapeutically equivalent to the RLD Depakote Sprinkle capsules, 125 mg of AbbVie Inc.

Schizophrenia and hypertension products also in the list

Alembic also disclosed USFDA final approval for Paliperidone extended-release tablets for schizophrenia. The filing covered strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg, and stated the generic is therapeutically equivalent to the RLD Invega extended-release tablets from Janssen Pharmaceuticals, Inc. Separately, the text notes that on November 11, 2024, Alembic announced final approval from the USFDA for Diltiazem Hydrochloride Extended-Release capsules used for hypertension. The approved strengths for those capsules include 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg. The material also notes that diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications.

Icatibant injection: first peptide injection approval and market size

The provided excerpt from an industry magazine references Alembic receiving USFDA final approval for its ANDA for icatibant injection used for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. It describes the product as a single-dose prefilled syringe and notes that this was the company’s first peptide product approval from the USFDA. It also states that the approved ANDA is therapeutically equivalent to the RLD Firazyr injection, of Takeda Pharmaceuticals U.S.A., Inc. The same excerpt cites an estimated market size of USD 112 million for the twelve months ending March 2024, according to IQVIA. In that context, the excerpt states Alembic had a cumulative total of 205 ANDA approvals, consisting of 177 final approvals and 28 tentative approvals.

Snapshot table of approvals mentioned

Market impact: what investors track in such updates

USFDA approvals matter for Indian pharma companies because they determine which products can be marketed in the US as generics. In Alembic’s case, the Diltiazem tablets approval expands its portfolio in a therapy area where multiple strengths are approved under the same filing. The company’s disclosure that the product is therapeutically equivalent to Cardizem is a key regulatory detail that supports generic substitution. Tentative approvals like the one cited for Bosutinib are also tracked because they indicate progress through the regulator, even if final clearance is still pending. The approval-count disclosures, such as “230 ANDA approvals (210 final, 20 tentative),” are used by the market as a proxy for consistency of filings and approvals over time.

Why the story matters for the US generics pipeline

The set of approvals referenced across the material spans cardiovascular care, central nervous system therapy, psychiatry, and acute care injections. That breadth indicates Alembic’s US pipeline is not concentrated in a single category, at least within the products explicitly cited here. It also shows repeated emphasis on therapeutic equivalence to named RLDs, a core requirement for ANDA-based generics in the US. The differing cumulative approval numbers appearing in separate contexts underscore that these updates were made at different points in time, and investors typically map each count to the announcement date. For readers tracking execution, the practical takeaway is that Alembic continues to add US-approved products, while also moving some filings through tentative stages.

Conclusion

Alembic’s latest disclosures highlight a final USFDA approval for Diltiazem Hydrochloride Tablets USP across four strengths and a tentative approval for a supplemental filing for Bosutinib Tablets 400 mg. The company has stated that its cumulative USFDA ANDA approvals have reached 230, including 210 final approvals and 20 tentative approvals. Other approvals cited in the provided material include products referencing hypertension, epilepsy, schizophrenia, DVT and PE prophylaxis, and hereditary angioedema. The next concrete milestone investors usually watch after such approvals is whether the company discloses launch timelines or commercialisation updates for the newly approved products.