Company News

19 December 2024

Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP

Zydus Life sciences Limited has received final approval from the United States Food and Drug Administration to manufacture Lidocaine and Prilocaine Cream USP.

19 December 2024

Granules India Limited announces FDA approval for ADHD Treatment

Granules India Limited, a vertically integrated Indian pharmaceutical company, announced today that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. , has received approval from the U.S. Food & Drug Administration for its Abbreviated New Drug Application for Lisdexamfetamine Dimesylate Chewable Tablets.

11 December 2024

Suven to acquire controlling stake in NJ Bio Inc.

Suven Pharmaceuticals Limited a technology-leading CDMO specializing in complex and innovative drug modalities, has announced the acquisition of a controlling stake in NJ Bio Inc. with an investment of USD 64.4 million.

31 July 2024

Zydus and Roche legal battle highlights need for affordable breast cancer treatments in India, says GlobalData

Zydus Life Sciences is engaged in a legal battle with Roche over its biosimilar, Sigrima, which is based on Roches Perjeta Pertuzumab, targeting the human epidermal growth factor receptor 2-positive breast cancer market in India.

29 July 2024

Another Indian discovered medicine, deuruxolitinib gets FDA approval against baldness

Indian Pharma giant, Sun Pharma gets the U.S. Food and Drug Administration, FDA approval for LEQSELVI deuruxolitinib 8 mg tablets for the treatment of adults with severe alopecia areata.

10 July 2024

Johnson & Johnson receives approval from USFDA and European Commission for SIRTURO (bedaquiline)

Johnson and Johnson announced that the US Food and Drug Administration has issued traditional approval for SIRTURO bedaquiline as part of combination therapy in adult and pediatric patients 5 years and older and weighing at least 15 kg with pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid

26 June 2024

Novo Nordisk announces 4.1 billion USD investment to expand US manufacturing capacity

Novo Nordisk today announced plans to invest 4.1 billion US dollars (approx 27 billion Danish kroner) to build a second fill and finishing manufacturing facility in Clayton, North Carolina, and grow its ability to produce current and future injectable treatments for people with obesity and other serious chronic diseases.

14 June 2024

Suven to acquire a majority stake in an oligonucleotide focused CDMO player, Sapala Organics

Suven Pharmaceuticals Limited has executed definitive agreements today, i.e. on June 13, 2024, for acquiring 100% of equity shares (on a fully diluted basis) (Proposed Transaction) in Sapala Organics Private Limited.

16 May 2024

Lupin Achieves Significant Milestone with ISO 14001 and ISO 45001 Certification Across All its Indian Manufacturing Sites, R&D Center and Corporate Office

Global pharma major Lupin Limited announced that all 12 of its manufacturing sites, its R&D Center and corporate office in India have successfully completed rigorous audits and been certified by DNV for ISO 14001 Environment Management Systems (EMS), and ISO 45001 Occupational Health and Safety Management System (OHSMS). This achievement marks a significant milestone in acknowledging Lupin’s commitment to safe and sustainable operations.

8 May 2024

Alembic Pharma received EIR for its Oncology Facility

Alembic Pharmaceuticals Limited received an Establishment Inspection Report (EIR) for its Oncology (Injectable and Oral Solid) Formulation Facility at Panelav.

On 8th March, 2024, US FDA Inspection at Alembic Pharmaceuticals Limited’s Oncology (Injectable and Oral Solid) Formulation Facility at Panelav.