Alembic Pharma gets USFDA nod for its antibiotic capsules
The approval from USFDA is for the company's abbreviated new drug application (ANDA) in the strengths of 50 mg and 100 mg, Alembic Pharma said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 14, 2018 Category: Pharmaceuticals Source Type: news

Lupin launches generic antibiotic inhalation solution in US
The company has launched the product as it has received an approval from the US Food and Drug Administration (USFDA) earlier, Lupin said in a filing to BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 13, 2018 Category: Pharmaceuticals Source Type: news

NPPA fixes prices of 22 drug formulations
While National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of 20 formulations, it has also capped the ceiling prices of two formulations, a notification on the regulator's website said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 13, 2018 Category: Pharmaceuticals Source Type: news

China to conduct training programmers for Indian pharmaceutical companies
The move assumes significance as it takes years for Indian pharmaceutical companies to obtain regulatory clearances for their products in China. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 12, 2018 Category: Pharmaceuticals Source Type: news

USFDA clears Sun Pharma ’s Halol plant, two years after it went under import ban
The USFDA ’s Establishment Inspection Report (EIR) comes days after the company received Voluntary Action Indicated (VAI) that indicated that clearance for the plant wasn’t too far away. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 12, 2018 Category: Pharmaceuticals Source Type: news

NCLT admits insolvency plea against Sterling Biotech
Senior officials from banking circles said that Andhra Bank, which is the lead bank in this case, has called a meeting of lenders on Tuesday to discuss the loan account and ways to resolve it. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 12, 2018 Category: Pharmaceuticals Source Type: news

Bankruptcy court admits lenders insolvency plea against Sterling Biotech
Senior officials from the banking circle said that Andhra Bank, which is the led bank has called a meeting of lenders on Tuesday to discuss the loan account and ways to resolve it. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 11, 2018 Category: Pharmaceuticals Source Type: news

Complex generics, biosimilars & specialty to be growth drivers: Lupin
While sustaining and growing its presence in the generics segment, Lupin is planning to invest heavily in developing high barrier products in complex generics, the presentation said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 10, 2018 Category: Pharmaceuticals Source Type: news

Cipla targets $1-billion revenues from domestic market in FY19
The company reported revenues of Rs 15,219 crore, growing 6 per cent, with income from the India operations seeing a 6.3 per cent jump at Rs 5,687 crore in FY18. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 10, 2018 Category: Pharmaceuticals Source Type: news

Biocon-Mylan win US nod for another biosimilar drug
Biosimilars are emerging as the new class of affordable drugs. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 6, 2018 Category: Pharmaceuticals Source Type: news

Sun Pharma rises with R & D and bets on specialty drugs
Sun Pharma- India's largest drug maker - is vying for its share in the US$9 billion market through a drug, Ilumya, that treats moderate-to-severe psoriasis. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 5, 2018 Category: Pharmaceuticals Source Type: news

Government may bring in new curbs on drug prices this month
Among the changes proposed by the govt is the move to introduce a new price index for pharmaceutical products that will become the benchmark to determine prices of all medicines sold in the country. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 3, 2018 Category: Pharmaceuticals Source Type: news

Dr Reddy's expects to launch over 15 products in US in FY'19
The Hyderabad-based drug major also remains optimistic for a double digit growth in the domestic market in the ongoing financial year. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 3, 2018 Category: Pharmaceuticals Source Type: news

Alembic Pharma plans Rs 720-crore capex for FY19
The pharma firm has filed 12 ANDAs (abbreviated new drug applications) during the March quarter, taking the total filings in FY18 to 26. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 3, 2018 Category: Pharmaceuticals Source Type: news

Mylan-Biocon ’s insulin biosimilar faces FDA hurdle
Firms have been asked to share details about a change in the manufacturing site for glargine from Bengaluru to a new facility in Malaysia. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 2, 2018 Category: Pharmaceuticals Source Type: news

Zydus gets final nod from USFDA for anti-bacterial drug
Zydus Cadila is a global pharmaceutical company that develops, manufactures and markets a broad range of healthcare therapies. The group employs over 21,000 people worldwide. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 2, 2018 Category: Pharmaceuticals Source Type: news

Shortage of important form of penicillin affecting 39 countries, including India: AMF
In Brazil, the shortage of penicillin coincided with a syphilis outbreak that, as a result, could not be brought under control. Between 2012 and 2015. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 1, 2018 Category: Pharmaceuticals Source Type: news

Lupin hire Nicholas Hart to head US business
His past experiences include Business Unit Head for Reproductive Health at Ferring Pharmaceuticals, Inc and Senior Vice President of Sales and Marketing at URL Pharma. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 31, 2018 Category: Pharmaceuticals Source Type: news

Pharmaceutical companies offering freebies may come under GST lens
The tax heads of firms such as Novartis India, Sun Pharma, Cipla, Lupin have been summoned for meetings with tax officials, they said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 30, 2018 Category: Pharmaceuticals Source Type: news

Fortis defers board meeting scheduled to consider financial results
Fortis Healthcare today said the board meeting scheduled to consider financial results for fourth quarter and financial year ended March 31, 2018, has been deferred to June 11. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 30, 2018 Category: Pharmaceuticals Source Type: news

Zydus Cadila gets USFDA nod for skin ointment, stomach ailment drug
Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Nystatin Ointment USP, 100,000 units per gram. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 28, 2018 Category: Pharmaceuticals Source Type: news

Zydus Cadila gets USFDA nod for prostate condition treatment drug
The drug is used to treat symptoms of Benign Prostatic Hyperplasia (BPH) -- also called prostate gland enlargement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 25, 2018 Category: Pharmaceuticals Source Type: news

Govt plans regulations for critical medical devices like pacemaker, X-ray machines
Govt plans to set quality standards for implantable medical devices and equipment, including defibrillators, dialysis and X-ray machines as well as PET, CT scan and MRI equipment. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 24, 2018 Category: Pharmaceuticals Source Type: news

Soon a text message will be enough to spot fake medicines
The Drugs Technical Advisory Board (DTAB) approved a proposal for a “trace and track” mechanism during a meeting held on May 16, the official said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 24, 2018 Category: Pharmaceuticals Source Type: news

Can develop vaccine to fight Nipah if government asks for it, says Serum Institute
Even as the government machinery is busy trying to contain the spread of the Nipah virus outbreak in Kerala, there is no vaccine yet to fight the disease. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 24, 2018 Category: Pharmaceuticals Source Type: news

Pfizer Inc recalls 1.8 million vials of antibiotics
"Piperacillin and tazobactam have been found to contain elevated levels of impurities that may result in decreased potency," a notification of the US Food and Drug Administration said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 23, 2018 Category: Pharmaceuticals Source Type: news

Aurobindo eyes Mallinckrodt Opioids Again
The US President has declared opioid addiction a public health emergency and drugmakers find themselves under scrutiny for allegedly contributing to the crisis. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 23, 2018 Category: Pharmaceuticals Source Type: news

Sun Pharma gets USFDA nod for prostate cancer drug
Sun Pharma had acquired YONSA from Churchill Pharmaceuticals and will commercialise the drug in the US. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 23, 2018 Category: Pharmaceuticals Source Type: news

Pharma cos marketing medicines made by third parties to soon be liable for quality lapses flagged by CDSCO
The move is expected to check lapses in quality of medicines consumed by patients in the country, according to persons aware of the development. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 22, 2018 Category: Pharmaceuticals Source Type: news

Marketers to be liable for violation of rules by pharma companies
The move is expected to check lapses in quality of medicines consumed by patients in the country, according to persons aware of the development. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 22, 2018 Category: Pharmaceuticals Source Type: news

Suven Life gets product patents from New Zealand, Norway
These patents are valid till 2034 and 2027, respectively, the company said in a BSE filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 22, 2018 Category: Pharmaceuticals Source Type: news

US opioid crisis hits Indian pharma companies
The total market size of opioid-based painkillers is estimated at $24 billion, with Fentanyl and Oxycontin being some of the commonly prescribed drugs. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 18, 2018 Category: Pharmaceuticals Source Type: news

Stempeutics partners with Cipla for its stem cell drug
Founded in 2006 by Manipal Education and Medical Group (MEMG), Stempeutics later entered into an alliance with Cipla in 2009. It is an advanced clinical stage biotech firm. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 18, 2018 Category: Pharmaceuticals Source Type: news

After Manipal-TPG, IHH extends validity of offer for Fortis
IHH's offer to infuse up to Rs7,400 crore into Fortis and acquire over 50% stake in the company is now valid until May 29, the company told the Malaysian stock exchange on Thursday. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 17, 2018 Category: Pharmaceuticals Source Type: news

Glenmark Pharma launches generic version of asthma drug in Denmark
The product was developed by Celon Pharma and Glenmark has marketing and distribution rights for the product across 15 European countries. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 16, 2018 Category: Pharmaceuticals Source Type: news

Lupin makes impairment provision for Gavis
Lupin took a hit worth Rs 1,464.35 crore on US-based Gavis, which it acquired in 2015 for $880 million (Rs 5,610 crore then). (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 15, 2018 Category: Pharmaceuticals Source Type: news

Orchid Pharma faces liquidation as lenders reject resolution plan
Orchid Pharma was referred to the bankruptcy court by Lakshmi Vilas Bank after it failed to pay about Rs 3,500 crore to lenders. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 15, 2018 Category: Pharmaceuticals Source Type: news

China's plans to import Indian drugs fail to enthuse Indian pharmaceutical firms
On May 4, China said it had removed import duties on as many as 28 medicines, but the need for lengthy trials and approvals has dampened enthusiasm among Indian firms. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 13, 2018 Category: Pharmaceuticals Source Type: news

Aurobindo Pharma's arm recalls 2 antibiotic injections from US
According to a letter issued to the USFDA, the recall of Ampicillin and Sulbactam has been initiated due to customer complaints of the presence of red particulate matter in the product. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 13, 2018 Category: Pharmaceuticals Source Type: news

'Indian IP and liabilities law barrier to pharma R & D investment'
India's intellectual property regulations and liabilities laws pose a major barrier to foreign companies, specially from the US, that prevents them from increasing their footprint in the country's huge market, pharma sector leaders have said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 10, 2018 Category: Pharmaceuticals Source Type: news

Novartis India appoints Milan Paleja as vice chairman and MD
Paleja is currently country president at Novartis in India and is also responsible for the pharmaceuticals business in the country. He is also a managing director of Novartis Healthcare Pvt Ltd. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 10, 2018 Category: Pharmaceuticals Source Type: news

Suven Life Sciences' Pashamylaram facility successfully completes USFDA inspection
The facility has undergone renewal inspection from February 5-18 by the United States Food and Drug Administration (USFDA), Suven Life Sciences said in a filing to BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 7, 2018 Category: Pharmaceuticals Source Type: news

Pharma exports can cross $20 bn by 2020: Chief of Pharmexcil
India ’s pharma exports grew 2.91% to $17.27 billion in 2017-18, according to the council. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 6, 2018 Category: Pharmaceuticals Source Type: news

Zydus Cadila gets USFDA nod for anesthesia drug
The company has received an approval from the United States Food and Drug Administration (USFDA) to market its product in the US market, Zydus Cadila said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 5, 2018 Category: Pharmaceuticals Source Type: news

CDSCO issues show cause notice to Glenmark over clinical trial in Jaipur
The apex drug regulatory body has sent show cause notices to Glenmark as well as the investigator in charge of the trial at the hospital, senior government officials said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 3, 2018 Category: Pharmaceuticals Source Type: news

Dilip Shanghvi ’s daughter Vidhi to head consumer healthcare business at Sun Pharma
Three years after son Aalok Shanghvi was inducted as emerging markets head of Sun Pharma, the company introduced daughter Vidhi Salgaocar as head of the Consumer Healthcare business. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 30, 2018 Category: Pharmaceuticals Source Type: news

Radia to enter NCR mkt with 600-bed hospital in Gurgaon
Called PrimaMed, the 600-bed facility is coming up on Golf Course Road and will mark the entry of Nayati Healthcare, which is promoted by Niira Radia, in NCR. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 28, 2018 Category: Pharmaceuticals Source Type: news

Fortis says Manipal-TPG waiver offer makes it difficult to run bidding process
Manipal-TPG had sought the right to deliver a revised proposal to the Fortis board during a period of no less than seven business days from the expiry of the new offer deadline. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 25, 2018 Category: Pharmaceuticals Source Type: news

Manipal-TPG submits revised bid for Fortis in run up to expert committee meet
According to Manipal-TPG's new offer, the consortium has hiked the premium offered over and above the equity valuation for Fortis Healthcare's hospital business to Rs 1,319 crore from Rs 1,058 crore earlier. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 25, 2018 Category: Pharmaceuticals Source Type: news

Dr Reddy's gets EIR from USFDA for UK plant
The USFDA issues an EIR to the establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 24, 2018 Category: Pharmaceuticals Source Type: news