Zydus Gets USFDA Approval for Glatiramer Acetate, Copaxone Generic

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL...

NPPA Caps Prices of 84 Drug Combinations, Including Empagliflozin Variants

The National Pharmaceutical Pricing Authority (NPPA) has set 84 drug formulations' retail prices, including 36 formulations of empagliflozin, a diabetes drug that was originally developed by German firm Boehringer Ingelheim...

FDCA Gujarat Acts Against Illegal Psychotropic Drug Sales

A significant attempt to stop illegal sale of narcotic and psychotropic drugs has been made by the Gujarat Food and Drugs Control Administration (FDCA) in a major crackdown effort on the illicit sale of drugs in the state...

Indian Drugmakers Face Heat as FDA Expands Surprise Global Inspections

In an effort to improve consumer safety and reinforce regulatory compliance, the US Food and Drug Administration (FDA) announced on Tuesday that it will raise the frequency of surprise inspections at foreign manufacturing facilities.

DTAB Recommends All Antimicrobials Be Treated as New Drugs to Tackle AMR

In a major regulatory move aimed at curbing antimicrobial resistance (AMR), the Drugs Technical Advisory Board (DTAB) has recommended that all antimicrobials should be permanently classified as...

Alembic Pharma Eyes FY26 Growth with Domestic Surge and Global Push

Alembic Pharmaceuticals has raised its expectation margin for FY26, with increased domestic sales, and international expansion. The CFO of the company, R.K.Baheti informed Moneycontrol that the company recorded higher E...

Govt Set to Roll Out Stricter Norms for Biosimilar Approvals

The Indian government is putting final touches on revised regulations to tighten quality requirements for biosimilar medicines, treatments derived from living cells applied in the treatment of cancers and...

Pharma Firm Corona Remedies Files Rs. 800 Crore IPO with SEBI

The Securities and Exchange Board of India (SEBI) is to launch a Rs. 800 crore Initial Public Offering (IPO) with the Draft Red Herring Prospects (DRHP)

Authorities Propose Stricter Control of Tapentadol under Narcotics Act

Tapentadlol is used for patients who have limited substitute treatment options and for pain.

AbbVie Gets FDA Nod for Rinvoq in Treating Giant Cell Arteritis

A daily dose of Rinvoq (upadacitinib) 15 mg from AbbVie now receives FDA approval for treating severe autoimmune condition Giant Cell Arteritis (GCA) despite the lack of a cure while the disease progresses to threaten vision along with stroke and aor

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