At the conclusion of the inspection, the USFDA has issued a Form 483 with three observations

The USFDA has classified the inspection outcome as Voluntary Action Indicated

The USFDA has classified the inspection outcome as Voluntary Action Indicated

The company’s Bangalore facility has received five observations from USFDA

The USFDA had conducted a routine current cGMP inspection at the facility during the period from May 12, 2026 to May 20, 2026

The initial consideration for the transaction is $12 million, payable at closing

The initial consideration for the transaction is $12 million, payable at closing

Neviton and Arco Lab synergize their strengths and enables Arco Lab to offer better knowledge-based and IT services

Neviton and Arco Lab synergize their strengths and enables Arco Lab to offer better knowledge-based and IT services

The successful closure of inspection further strengthens the company’s U.S. business and near-term growth prospects

USFDA has concluded routine current Good Manufacturing Practices inspection at the formulations facility of Strides Pharma Inc.

At the conclusion of the inspection, the USFDA has issued a Form 483 with four observations

Strides will collaborate with Kenox on the development and filing of multiple nasal spray products for the US market across diverse therapeutic indications

Strides will collaborate with Kenox on the development and filing of multiple nasal spray products for the US market across diverse therapeutic indications

Two (out of the Four) ANDAs acquired are commercial products and is expected to be launched within 12 months

Two (out of the Four) ANDAs acquired are commercial products and is expected to be launched within 12 months

Pivot Path shall focus on life sciences and manufacturing solutions with deep domain knowledge and cutting-edge technology capabilities

Pivot Path shall focus on life sciences and manufacturing solutions with deep domain knowledge and cutting-edge technology capabilities

Arco Lab will incorporate the NewCo to facilitate the proposed demerger

The Acetaminophen and Ibuprofen tablets will be manufactured at the company’s flagship facility in KRSG, Bengaluru

The acquisition marks a significant milestone in Strides’ expansion efforts, further strengthening its position in the region

This project will facilitate harnessing solar energy at the company’s Alathur facility

This project will facilitate harnessing solar energy at the company’s Alathur facility

The Fluoxetine tablets will be manufactured at the company’s facility in Puducherry

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug Prozac Tablets of Eli Lilly

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug Prozac Tablets of Eli Lilly

The inspection closed with two observations

The Gabapentin tablets will be manufactured at the company’s facility in Puducherry

The Gabapentin tablets will be manufactured at the company’s facility in Puducherry

The product is bioequivalent and therapeutically equivalent to the RLD, Lyrica capsules of Upjohn US

The product is bioequivalent and therapeutically equivalent to the RLD, Lyrica capsules of Upjohn US

With the said acquisition, Arco Lab holds 50% stake in Neviton

With the said acquisition, Arco Lab holds 50% stake in Neviton

The Management Committee of the Board of Directors of the Company in its meeting held on January 2, 2024, has approved the same

The Management Committee of the Board of Directors of the Company in its meeting held on January 2, 2024, has approved the same

The Product has a market size of $143 Million per IQVIA. The Product will be manufactured at the company’s facility in Bengaluru

The Product has a market size of $143 Million per IQVIA. The Product will be manufactured at the company’s facility in Bengaluru

The product will be manufactured at the company’s facility in Bengaluru

The product will be manufactured at the company’s facility in Bengaluru

Proceeds from the transaction will be utilized for debt reduction

The product will be manufactured at the company’s facility in Bengaluru

It is proposed to combine the identified CDMO business of Strides and the identified CDMO business of Steriscience under Stelis

The Product will be manufactured at the company’s facility in Bengaluru

The company has set a target to launch around 60 new products over three years in the US

The company has set a target to launch around 60 new products over three years in the US

The approval completes the company’s Sevelamer Carbonate portfolio

The Board of Directors of the company at their meeting held on September 7, 2023, has approved the same

The Board of Directors of the company at their meeting held on September 7, 2023, has approved the same

The approval bolsters the company’s Mycophenolate Mofetil portfolio, which already includes numerous products in which the company is a market leader

The approval bolsters the company’s Mycophenolate Mofetil portfolio, which already includes numerous products in which the company is a market leader

Syngene shall acquire Unit 3 on a slump sale basis for a gross value of Rs 7,020 million

The USFDA has classified the facility from Official Action Indicated to Voluntary Action Indicated

The USFDA has classified the facility from Official Action Indicated to Voluntary Action Indicated

Strides will commercialize these nasal sprays across the markets using its commercial engine in the US, Europe, and several other markets

Strides will commercialize these nasal sprays across the markets using its commercial engine in the US, Europe, and several other markets

The Company’s flagship facility was inspected by the USFDA between December 5 and 9, 2022

This Abbreviated Quality System Inspection Technique drug preapproval on-site inspection was specifically conducted by the USFDA

Stelis will manufacture and commercially supply the product to its CDMO partner from its flagship facility in Bangalore, India

The company’s arm has received AUD 94 million as deferred consideration for sale of Australian operations

The proceeds will be utilized for deleveraging the balance sheet

The proceeds will be utilized for deleveraging the balance sheet

The approval further strengthens the Potassium Chloride franchise for the company which now comprises of Extended-Release Capsules, Extended-Release Tablets, Powder for Oral Solutions and Oral Solutions

The approval further strengthens the Potassium Chloride franchise for the company which now comprises of Extended-Release Capsules, Extended-Release Tablets, Powder for Oral Solutions and Oral Solutions

This outcome for the DP facility comes after the USFDA on-site PAI at Stelis flagship manufacturing facility for several product submissions by the partners to the agency

This outcome for the DP facility comes after the USFDA on-site PAI at Stelis flagship manufacturing facility for several product submissions by the partners to the agency

As per the USFDA, the company is recalling the affected lot due to presence of foreign tablet

The inspection was completed successfully with Zero 483 observations

The company is the first Indian company to get approval for the product

Strides is the first Indian company to get approval for the product

A meeting of the Committee of Directors is scheduled to be held on July 25, 2022, inter alia, to consider and approve the same

The affected lot of tables, in strengths of 25 mg, 50mg and 100 mg, have been manufactured by Vivimed Life Sciences in a Tamil Nadu-based plant

The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market

The US market for Ibuprofen Oral Suspension USP, 100 mg/5 mL is approximately $66 million

The US market for Ibuprofen Oral Suspension USP, 100 mg/5 mL is approximately $66 million