Page 3 - Pharmaceutical

DCGI streamlines drug export approval, plans revised biosimilar guidelines

Previously, companies exporting drugs from India had to apply for a customer- and quantity-specific NOC each time they received an order

MO Alts acquires majority stake in Megafine Pharma for Rs 460 crore

Megafine currently operates two USFDA-approved manufacturing facilities located in Nashik, Maharashtra, and Vapi, Gujarat, and specialises in niche, high-margin APIs, primarily used in chronic disease

CDSCO withdraws export NOC, bans drugs linked to West Africa opioid crisis

The ministry added that Aveo Pharmaceuticals has been issued a Stop Activity Order, halting all operations at the company's premises after a comprehensive audit

Pharma stocks plunge amid tariff concerns, but analysts see limited impact

Pharma stocks fell on Friday on concerns of tariff on imports

NPPA sets prices for 42 drugs, revises ceiling for 2 formulations

Prices have been fixed for drugs and formulations meant for diabetes, hypertension, heart issues, bacterial infections, allergies, and multivitamins

Commerce Ministry withdraws 'track and trace' rule for pharma exports

The Commerce Ministry on Friday said it has withdrawn the provisions related to the track and trace system for pharmaceutical exports under the foreign trade policy. The implementation of the authentication system for drug formulations being exported will be undertaken by the Ministry of Health and Family Welfare in line with the provisions under Drug Rules 1945, according to a public notice of the Directorate General of Foreign Trade (DGFT). "The DGFT has decided to streamline export regulations by aligning with the evolving regulatory framework of the Ministry of Health & Family Welfare. Accordingly, the provisions related to the track and trace system for pharmaceutical exports under the Foreign Trade Policy are being withdrawn," the ministry said. The system, introduced on January 10, 2011, mandated barcoding at various packaging levels. While tertiary and secondary packaging requirements were successfully implemented in 2011 and 2013, primary-level barcoding and parent-child .

OneSource sees surge in demand as semaglutide patents near expiry

The company emphasised that it is ready to meet the growing demand for drug-device combinations and biologics, with semaglutide formulations being a focal point

Mankind Pharma Q3FY25 results: PAT falls 16.5%, revenue rises 24%

Mankind's revenue from operations rose to Rs 3,230 crore in Q3FY25, a 24 per cent Y-o-Y rise from Rs 2,607 crore reported in Q3FY24

PharmEasy founders step back to launch new venture in consumer space

Siddharth Shah, chief executive officer (CEO) and managing director (MD) of PharmEasy has also invested in the new venture in his personal capacity

Sun Pharma's unit Taro to acquire 100% stake in Antibe Therapeutics

The acquisition is expected to be completed before March 7, 2025, subject to approval from the Ontario Superior Court of Justice

PAG acquires majority stake in Pravesha Industries for $200 million

PAG had earlier acquired Manjushree Technopack for $1bn

Lupin receives US FDA tentative approval for Ivacaftor Oral Granules

These granules, available in 25 mg, 50 mg, and 75 mg per unit dose packets, are a generic equivalent of Kalydeco Oral Granules

Lupin gets clearance from USFDA for its Pithampur manufacturing facility

Lupin, headquartered in Mumbai, India, is a global pharmaceutical player with products distributed in over 100 markets

Assembly lines adopt flexible robotics to meet rising consumer expectations

These systems can be deployed across various industries ranging from pharmaceuticals, and consumer goods to the automotive sector

Budget wishlist: Pharma firms seek simplified taxes, stronger PLI scheme

Among other demands is the removal of Section 194R, related to marketing samples, which would ease business operations

Pharmed Ltd chairman emeritus Krishan Kumar Aurora passes away at 88

Krishan Kumar Aurora, chairman emeritus of Pharmed Limited and BioPlus Group, passed away on December 23 at 88. He began his career in 1961 with Smith Kline & French, rising to VP for Southeast Asia

Despite short-term blip, Sun Pharma remains favourite among investors

According to Bloomberg, 30 of 41 analysts are bullish on Sun Pharma, while the remaining seven have a neutral rating and only 4 are bearish

Pharma major Cipla not in the pink of health; growth challenges galore

Brokerages slash target price after subdued Q2 show

Navigating Regulatory Challenges: The Role of Experts in Reducing QC Testing Errors

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Entod Pharma meets DCGI, issues clarification over eye drop 'claims'

Move comes after drug regulator had suspended nod granted to firm to manufacture, sell PresVu eye drops