Drug Makers In India

Drug maker Cipla gets 8 observations from USFDA for Bengaluru facility

Drug maker Cipla on Wednesday said the US health regulator has issued eight observations after inspecting its Bengaluru-based plant. The US Food and Drugs Administration (USFDA) conducted an inspection at the company's manufacturing facility in Virgonagar, Bengaluru from November 7- 13, the Mumbai-based based drug maker said in a filing to BSE. On conclusion of the inspection, the company received eight observations in Form 483, it added. The company said it will work closely with the USFDA and remain committed to addressing these observations comprehensively within stipulated time.

Drug firm Lupin names Claus Jepsen as President Global specialty business

Drug firm Lupin on Monday said it has appointed Claus Jepsen as President, Global Specialty business. Jepsen joins Lupin from Takeda Pharmaceuticals, where he led the Global Strategy for rare diseases. "His experience in leading specialty strategy, commercial planning and portfolio choices across key markets will enable us to build our Specialty brand business," Lupin CEO Vinita Gupta said.

Indian pharmacopoeia standard used by 11 countries: DCGI Rajeev Raghuvanshi

The WHO-led experts team approved India's vaccine regulatory system after an in-depth scientific review, conducted between September 16 and 20, as per a statement by the Ministry of Health and Family

CDSCO meets WHO standards for functional vaccine regulatory system

Drug regulator CDSCO and the National Regulatory Authority of India have met the standards set up by the World Health Organisation for a functional vaccine regulatory system A team of international experts from various countries led by the World Health Organisation (WHO) headquarters in Geneva reviewed India's vaccine regulatory system from September 16 to 20, the health ministry said in a statement. Safety, efficacy, and quality were the three basic parameters of assessment of vaccines, it said. The WHO has established global standards and benchmarks for assurance of vaccine quality through the development of tools and guidelines, benchmarking of the National Regulatory Authorities (NRA) and pre-qualification programme of vaccines, the statement said. The WHO NRA re-benchmarking was aimed to assess and document the status of the India regulatory system in the area of vaccine regulation, re-benchmark the status of the India vaccine regulatory system against the WHO NRA Global ...

'India's pharma exports expected to remain strong amid global slowdown'

Exports of India's pharmaceutical and meditech sectors are expected to sustain the growth momentum in the ongoing fiscal despite a slowdown in the global economy, a senior government official said on Wednesday. With the government revving up support for drug development in India, as many as 16 blockbuster molecules targeted for a wide range of therapeutic areas, including cancer, diabetes, HIV and tuberculosis, are in the pipeline to be produced in India, Department of Pharmaceuticals, Secretary Arunish Chawla told reporters on the sidelines of CII Pharma and Life Sciences summit here. "We have been analysing the export trends in the recent data. Even though there is a general slowdown in exports globally, the good news is that the Indian pharmaceuticals, biotech, and bulk drug exports have grown double-digit over the last year," he said in response to a query on export prospects of the pharma industry amid a global slowdown. He further said,"In the first four months of this year, .

Lupin inks pact with Scope Opthalmics to market eyecare products in Mexico

Drug maker Lupin on Monday said it has inked a distribution pact with Ireland-based Scope Ophthalmics to market a product range, indicated for the treatment of various eye conditions, in Mexico. The company has signed a distribution agreement with Scope for the registration and marketing of Moist Heat Mask, a Tea Tree Oil Eyelid Cleansing Gel and Tea Tree Oil Eyelid Wipes of the Optase range in Mexico. The products are used for eye conditions like dry eyes, blepharitis and meibomian gland dysfunction (MGD). "This expansion of our ophthalmology range reinforces our commitment to enhancing vision care for our patients, improving their quality of life," said Fabrice Egros, President Corporate Development and Growth Markets, Lupin. Through the signature of this collaboration with Lupin, Scope is expanding its footprint in Latin America, Scope CEO Tom Freyne stated. "Mexico is clearly a country of strategic importance for SCOPE where our innovative eyecare products, together with the

DCGI introduces new traceability rules to address fake medicines issue

The new guidelines have been formulated by India's drug regulatory body to ensure product traceability, which has been hindered by insufficient documentation throughout the distribution network

Abbott India Q1 results: PAT rises 13% to Rs 328 cr, income at Rs 1,625 cr

Drug firm Abbott India on Wednesday said its net profit increased by 13 per cent year on year to Rs 328 crore for the first quarter ended June 30, 2024. The company reported a net profit of Rs 290 crore in the April-June quarter of last fiscal. Total income rose to Rs 1,625 crore for the period under review as against Rs 1,535 crore in the June quarter of FY24, Abbott India said in a regulatory filing. Shares of the company on Wednesday ended 1.29 per cent up at Rs 28,159.95 apiece on the BSE.

Akums Drugs and Pharma's IPO gets fully-subscribed on Day 1 of offer

The initial public offer of Akums Drugs and Pharmaceuticals got fully-subscribed on the first day of subscription on Tuesday. The Rs 1,875-crore initial share sale received bids for 2,07,92,684 shares, as against 1,51,62,239 shares on offer, translating to 1.37 times subscription, as per the NSE data. The issue will conclude on August 1. The quota for Retail Individual Investors (RIIs) received 3.35 times subscription, while the Non Institutional Investors part got subscribed 1.96 times. The portion for qualified institutional buyers (QIBs) received 43 per cent subscription. The IPO is a combination of a fresh issue of equity shares worth Rs 680 crore and an offer-for-sale (OFS) of 1.73 crore shares valued at Rs 1,177 crore at the upper-end of the price band by promoters and an existing investor. Those selling shares in the OFS are Sanjeev Jain, Sandeep Jain and Ruby QC Investment Holdings Pte Ltd. The public issue has a price range of Rs 646 to Rs 679 per share Akums Drugs and

Govt plans regulatory crackdown on similar-sounding, look-alike drug brands

Drug manufacturers in India will soon be required to upload their product formulations and brand names on the government's portal

Ahead of IPO, Akums Drugs garners Rs 829 crore from anchor investors

Akum Drugs and Pharmaceuticals Ltd on Monday said it has collected Rs 829 crore from anchor investors a day before its share-sale opening for public subscription. Abu Dhabi Investment Authority, Smallcap World Fund, Inc, HSBC Global Investment Funds, SBI Mutual Fund (MF), Bandhan MF, Motilal Oswal MF, Aditya Birla Sun Life MF, SBI Life Insurance Company, HDFC Life Insurance Company and ICICI Prudential Life Insurance Company are among the anchor investors. According to a circular uploaded on NSE's website, the company has decided to allocate 1.22 crore shares to 50 funds at Rs 679 apiece, aggregating the transaction size to Rs 828.78 crore. The issue, with a price band of Rs 646 to Rs 679 per share, will open for public subscription on July 30 and conclude on August 1. The Rs 1,875-crore IPO is a combination of a fresh issue of equity shares worth Rs 680 crore and an offer for sale (OFS) of 1.73 crore shares valued at Rs 1,177 crore at the upper end of the price band by promoters

Sun Pharma open to exploring acquisitions in global specialty portfolio

Sun Pharma has net cash position of $2.4 bn at end of FY24; 6 new specialty products in R&D pipeline

60 drug makers join govt scheme to modernise pharma manufacturing units

Indian pharmaceutical companies recently came under the scanner after global supplies of certain medicines were found to be toxic

USFDA highlights quality concerns over drugs manufactured in India

USFDA launches QMM program to reduce drug shortages and improve supply chain issues

CDSCO cracks whip on drug manufacturing units over quality lapses

Shuts down 36% of facilities for failing to meet quality standards

Regulatory action: Shock and awe

Rather than surprising investors with their final decisions, disclosing findings on an ongoing basis would better prepare the market for eventual outcomes

Govt planning regulatory crackdown on look-alike, sound-alike drug names

In order to safeguard patients, the Drug Technical Advisory Board (DTAB) proposed banning the production and marketing of distinct drugs under identical brand names

Domestic drugs formulations market to be worth Rs 5.5 trn by 2034: Report

'Significant under-penetration' in domestic market, especially in smaller towns and rural areas

NPPA fixes retail prices for 54 drug formulations and 8 special products

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

Indian pharmaceutical companies likely to cash in on US drug shortages

US drug shortages hit a decade-high of 323 across 22 therapies in the March quarter of 2024