Regulation, Compliance & Legal › Sub-category

Licence / Approval / Cancellation

7 articles
Regulatory approvals and expansions are shaping the landscape for several Indian pharmaceutical and energy companies. Morepen Labs advanced its presence in the U.S. market by submitting an ANDA for Sitagliptin, targeting a market with significant revenue potential, while Zydus Lifesciences received a clean bill of health from a USFDA pharmacovigilance inspection. Simultaneously, IEX is strategically diversifying into the coal market through its subsidiary, and Biocon Malaysia secured MHRA approval for its insulin drug product fill finish unit, further solidifying its international manufacturing capabilities. These developments suggest a continued focus on regulatory compliance and expansion within the healthcare and energy sectors, potentially benefiting investors seeking exposure to these growth areas.
Aurobindo Pharma Receives USFDA Approval for Perampanel
Aurobindo Pharma received USFDA final approval for Perampanel Tablets across six dosage strengths for epilepsy treatment. The product has an estimated market size of $67 million and will be manufactur
Indiabulls Gets RBI Core Investment Company Registration
Indiabulls Ltd received RBI registration as a Core Investment Company under SEBI LODR Regulation 30. The company disclosed the registration may be surrendered if found non-applicable, pending internal
Industrial Co‑op Bank Guwahati Extension to Jan 2027
RBI extends its Section 35A directions for The Industrial Co‑operative Bank Ltd., Guwahati to Jan 4 2027, adding three months. The previous extension had already pushed the deadline to Oct 4 2026 afte
Innovative Co-operative Urban Bank 3‑Month Extension
RBI extends the operational directive for Innovative Co-operative Urban Bank Limited by three months, from 4 Oct 2026 to 4 Jan 2027. The extension follows a prior six‑month directive (July 4 2025‑Jan
HDFC Bank Appoints Anup Bagchi as MD & CEO
HDFC Bank appoints Anup Bagchi as MD & CEO for 3 years effective October 27, 2026, following RBI approval. Bagchi joins from ICICI Prudential Life Insurance where he achieved Rs 10,407 crore APE and 4
Kotak Mahindra Bank RBI Approves Anup Saha MD CEO
Kotak Mahindra Bank receives RBI approval for Anup Kumar Saha's appointment as MD & CEO effective January 1, 2027 for a three-year term. Saha currently serves as Whole-time Director overseeing Retail
CSB Bank RBI Approves ICICI Prudential 9.95% Stake
RBI grants ICICI Prudential AMC approval to acquire up to 9.95% stake in CSB Bank. Approval is subject to compliance with Banking Regulation Act and SEBI regulations. Disclosure made pursuant to SEBI