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Company

ANI Pharmaceuticals

Pharmaceutical intelligence for ANI Pharmaceuticals with 7 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals: 4
Catalysts: 3
Assets: 5

Recent signals(4)

RegulatoryAugust 3, 2026

ANI Pharmaceuticals receives AP status for Leucovorin Calcium supplement

ANI Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval status for Leucovorin Calcium.

RegulatoryJune 28, 2026

FDA Approval Letter for Oxycodone Hydrochloride ANDA204979

The FDA has issued an approval letter for Oxycodone Hydrochloride under ANDA204979 submitted by ANI Pharmaceuticals.

RegulatoryJune 27, 2026

FDA Approves Supplement for Morphine Sulfate by ANI Pharmaceuticals

ANI Pharmaceuticals received FDA approval for a supplement related to Morphine Sulfate.

RegulatoryJune 24, 2026

ANI Pharmaceuticals submits supplemental application for Oxycodone and Aspirin

ANI Pharmaceuticals has submitted a supplemental application for a combination product containing Oxycodone and Aspirin.

Upcoming catalysts

No catalysts indexed for this entity yet.

Regulatory activity(4)

RegulatoryAugust 3, 2026

ANI Pharmaceuticals receives AP status for Leucovorin Calcium supplement

ANI Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval status for Leucovorin Calcium.

RegulatoryJune 28, 2026

FDA Approval Letter for Oxycodone Hydrochloride ANDA204979

The FDA has issued an approval letter for Oxycodone Hydrochloride under ANDA204979 submitted by ANI Pharmaceuticals.

RegulatoryJune 27, 2026

FDA Approves Supplement for Morphine Sulfate by ANI Pharmaceuticals

ANI Pharmaceuticals received FDA approval for a supplement related to Morphine Sulfate.

RegulatoryJune 24, 2026

ANI Pharmaceuticals submits supplemental application for Oxycodone and Aspirin

ANI Pharmaceuticals has submitted a supplemental application for a combination product containing Oxycodone and Aspirin.

Clinical activity

No signals indexed for this entity yet.

Competitive activity

No signals indexed for this entity yet.

Assets

Morphine Sulfate →

Oxycodone Hydrochloride →

Regulatory Approval →

Therapeutic areas

Opioid Combination →

Pain Management →

Pain Management · Opioid →

Pain Management · Opioid Combination →

Supportive Care →

Indications

No related entities indexed yet.

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