Piramal Pharma gets Form 483 with 2 observations from USFDA for Lexington, USA facility

The observations do not pose any risk to site's compliance standards or its business continuity

Orchid Pharma's 'Exblifep' receives USFDA approval

Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA

Lupin receives approval from USFDA for Minzoya

Minzoya Tablets are indicated for use by females of reproductive potential to prevent pregnancy

Zydus receives USFDA approval for Isosorbide Mononitrate Extended-Release, Tablets USP

Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease)

Aparna Group forays into pharma business; Receives USFDA clearance for manufacturing unit

The company is strongly committed to enhancing customer satisfaction and catering to the discerning needs of renowned pharmaceutical companies

Zydus receives Tentative Approval from the USFDA for Dexamethasone Tablets USP, 1 mg

Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions

Zydus receives USFDA’s final approval for Gabapentin Tablets, 300 mg and 600 mg

Gabapentin is indicated for the management of Postherpetic Neuraligia

Strides receives USFDA approval for Pregabalin Capsules

The Pregabalin capsules has a market size of ~US$248 mn per IQVIA

Lupin receives tentative USFDA approval for Rivaroxaban Tablets USP

Lupin receives USFDA’s approval for Febuxostat Tablets

Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)