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Under the agreement, SteinCares will hold exclusive rights to register, commercialize, and distribute the biosimilar across the region

The collaboration spans early development through commercialization, positioning Shilpa as a lifecycle partner for the program

The designation provides meaningful regulatory and commercial incentives, including development support, tax credits, and market exclusivity upon approval

Shilpa’s Rotigotine patches are indicated for treatment of Restless Legs Syndrome and Parkinson’s disease

The ten day inspection ended with the issuance of FDA Form 483 with eight inspectional observations none of which has been categorized as a repeat observation

OERIS (Ondansetron Extended-Release Injection) is an innovative formulation designed to improve prophylaxis of chemotherapy-induced nausea and vomiting (CINV)

This approval has come from the Company’s finished dosage form manufacturing facility, Shilpa Medicare, Unit VI, located at Dabaspet, Bengaluru, Karnataka

The new limited liability company will be majority owned by PPI (70%), with Koanna holding a 30% stake

This approval will allow Shilpa to become the first company in the World to launch this novel product in any part of the World for NAFLD

The GMP inspection was conducted from October 24-30, 2024

This facility of the company is engaged in the manufacture, testing, storage and release of finished dosage forms in the category of Oral Films and Transdermal Patches

The audit was carried out between June 30 to July 4, 2025 and has been concluded with No Critical and No Major observations

Under this agreement, Orion will be the exclusive partner for the distribution, marketing, and sales of Shilpa’s Recombinant Human Albumin in Europe

The inspection was carried out at unit-1 by USFDA between March 3 to March 7, 2025

The company has received GMP approval for its Unit VI located at Bengaluru, Karnataka

The total US market for this product is around $203 million.

The product has already been granted permanent J-code by U.S. Centers for Medicare & Medicaid Services

The inspection was closed with ZERO observations

On conclusion of inspection, the company received 1 observation in form 483, which is procedural in nature

Teriflunomide is a novel disease-modifying agent that was approved for use in the treatment of multiple sclerosis

Tadalafil is indicated for the treatment of erectile dysfunction (sometimes called impotence) in adult males

This approval will open up significant business opportunities in these countries

Nifedipine is in a class of medications called calcium-channel blockers in the dihydropyridine subclass

Octreotide is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis

The inspection concluded with the issuance of Form 483 with four observations

The product has already been granted permanent J-code by U.S. CMS

The said unit was inspected from January 22, 2024 to January 26, 2024

The issue opened on April 08, 2024 and closed on April 12, 2024

Its board has approved the floor price for the issue being Rs 477.33 per Equity Share for the issue

This USFDA inspection has been closed without any 483 observation

This is a newly set up Centre for bio-analytical testing

This approval will enable the company to secure approval and market its Oral Film products in Australia

The company has entered into Share Subscription and Shareholder’s agreement with Ash Ingredients

The object of acquisition is to establish front end presence in the US Market with an objective to capture the full potential of its niche portfolios

The successful closure of this inspection will allow the company to register and market its products in Australia and other rest of world markets which recognize Australian GMP

ORAAL, a substantial advancement in Oral Mucositis management, has been accepted and approved by the Indian Dental Association

This approval has come from the Company’s finished dosage form manufacturing facility, Shilpa Medicare, Unit VI, located at Dabaspet, Bengaluru, Karnataka

The inspection has concluded successfully on August 24, 2023 without any observations

It is the first company to receive approval for Lenvatinib Capsules, 12, 18 and 24 mg in India

This formulation will contribute to increased patient comfort based on reduced injection volume

This product is required to be administered intravenously without any further dilution

The US market for Apremilast Tablets, 10 mg, 20 mg, and 30 mg is around $3.55 billion

The inspection is closed with 2 minor observations

This GMP approval will allow the company for the commercial distribution of products in Canada and enable new application submissions to Health Canada

The FDA clearance on the facility will enable the company to test and release batches into US from this facility

The product is protected by granted patents in India till 2037 and in US, Australia, Russia and South Africa till 2038

The US market for Tenofovir Alafenamide Tablets, 25 mg is around $498.14 million

The company has submitted the dossier to the CDSCO for review and grant of marketing/manufacturing license - a first in India

The facility involves in manufacturing, testing, packing, storage of chemically synthesized nonsterile drug substances for human use

The facility was inspected by MHRA from April 18, 2022 to April 20, 2022

With effect from closing of the transaction, Shilpa Pharma Lifesciences, a wholly owned subsidiary of Shilpa Medicare shall operate the API business