Glenmark sells gynac business for Rs 115 crore
The sale of the gynac business comes two years after it sold its orthopedic business to the same company. Integrace will pay Rs 115 crore for four products of the portfolio that includes products like Dubagest, Mumfer and Fenza. These three products currently have sales of Rs 60 crore and are growing by 15%. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 21, 2020 Category: Pharmaceuticals Source Type: news

Zydus & CMS enter pact for Desidustat in Greater China
The agreement is for Desidustat, a novel oral HIF-PH inhibitor for the treatment of anemia in patients with Chronic Kidney Disease (CKD) not-on-dialysis and for the treatment of anemia CKD patients on dialysis in Greater China, Zydus said in a statement. "Under the license agreement, CMS will pay Zydus an initial upfront payment," it added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 20, 2020 Category: Pharmaceuticals Source Type: news

Pain for big Indian pharma companies continue warns CRISIL, as FDA woes remains unresolved
Indian drug makers in the last few years have diversified their portfolio towards complex generics in an attempt to insulate themselves from pricing pressure in the US. The complex generic pipeline of Indian generic makers stands at 25%, it is this pipeline that is expected to pump up the sales numbers for Indian companies. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 20, 2020 Category: Pharmaceuticals Source Type: news

Biocon Bengaluru unit pre-approval inspection by USFDA concludes with zero observations
Biocon on Monday said that pre-approval inspection of the Bengaluru facility of its arm conducted by US health regulator was concluded with zero observations. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 20, 2020 Category: Pharmaceuticals Source Type: news

Cipla announces closure of USFDA inspection at Patalganga facility
Cipla recently announced the closure of inspection by United States Food and Drug Administration (USFDA) at the Patalganga manufacturing facility in Maharashtra. Shares of Cipla were trading 0.40 per cent lower at Rs 478.35 apiece on the BSE in the morning trade. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 20, 2020 Category: Pharmaceuticals Source Type: news

Strides arm receives EIR for its US facility
The facility is one of the very few manufacturing facilities in the US with a soft gel capsule (SGC) manufacturing suite for formulations with containment needs, the company said. Strides has a portfolio of approved SGCs in the US and other regulated markets. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 20, 2020 Category: Pharmaceuticals Source Type: news

Lupin gets 5 observations from USFDA for its Vizag facility
The inspection of company's Vizag API manufacturing facility by the United States Food and Drug Administration (USFDA) has been completed, Lupin said in a filing to BSE. The inspection was carried out between January 13, 2020 and January 17, 2020, it added. The inspection for the API facility at Vizag closed with five 483 observations, Lupin said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 18, 2020 Category: Pharmaceuticals Source Type: news

What ails India's pharmaceutical sector?
Unlike mature markets such as the US, where drug prices are market-controlled, here, the government and regulators play a pivotal role in the entire process. Regulators fix both the price companies pay for bulk drugs and the price at which they sell their products in the market, leaving little leeway to earn profit. For Indian pharma, this is a double-edged sword. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 17, 2020 Category: Pharmaceuticals Source Type: news

Wockhardt gets DGCI approval for 2 new antibiotics
"DCGI (Drug Controller General of India) has approved Wockhardt's two new antibiotics, EMROK (IV) and EMROK 0 (Oral), for acute bacterial skin and skin structure infections including diabetic foot infections and concurrent bacteraemia...," the drug firm said. The new drug will target superbug like Methicillin resistant Staphylococcus aureus. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 16, 2020 Category: Pharmaceuticals Source Type: news

Strides gets USFDA nod for anti-allergic drug
The company said, it is focusing on building a private label business in the US by leveraging its portfolio of products across softgels, tablets, capsules and other proprietary formats. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 16, 2020 Category: Pharmaceuticals Source Type: news

PE Funds Advent, Kedaara in discussions to acquire Sequent
The founder promoters of Sequent, including serial entrepreneur Arun Kumar, KR Ravishankar and family, together hold about 56.5% in the listed entity, while PE investor Ascent Capital holds 5% stake. JP Morgan is running the sale process. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 15, 2020 Category: Pharmaceuticals Source Type: news

Sun Pharma, US-based Rockwell Medical enter into licensing pact for Triferic in India
As per the terms of the agreement, Sun Pharma will be the exclusive development and commercialisation partner for Triferic during the term of the agreement, subject to its approval in India. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 15, 2020 Category: Pharmaceuticals Source Type: news

Alembic gets USFDA nod for Tizanidine hydrochloride capsules used to treat spasticity
"The company has received final approval from the US Food& Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," the drug firm said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 15, 2020 Category: Pharmaceuticals Source Type: news

Pharma cos may face Rs 10-lakh penalty, 2-year jail term for deceptive drug ads
Pharmaceutical companies or anybody involved in exaggerating how well their drugs work will face exemplary penalty and imprisonment, according to the proposed amendments to the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 14, 2020 Category: Pharmaceuticals Source Type: news

USFDA classifies inspection of Lupin's Tarapur facility as 'Official Action Indicated'
According to FDA's definitions, Official Action Indicated means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during inspections. The company, however, said that it does not believe this inspection classification will have an impact on disruption of supplies or the existing revenues from operations of this facility. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 13, 2020 Category: Pharmaceuticals Source Type: news

Alembic gets USFDA nod for Vilazodone Hydrochloride tablets used to treat depression
"The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Viibryd tablets, 10 mg, 20 mg, and 40 mg, of Allergan Sales," the drug firm said. Citing IQVIA, the company said Hydrochloride tablets, 10 mg, 20 mg, and 40 mg, have an estimated market size of USD 469 million for 12 months ending September 2019. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 13, 2020 Category: Pharmaceuticals Source Type: news

Granules India says 'voluntarily' recalling ranitidine tabs
Granules India has said that it has received multiple queries on the news item for recall of ranitidine by the drug firm. The company is in the process of recall from channel partners and the exact quantities are being estimated. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 13, 2020 Category: Pharmaceuticals Source Type: news

HC Bars Cipla, 3 others from launching generic version of Bristol-Myers ’ drug
Delhi High Court has granted an injunction restraining the domestic pharma companies such as Cipla, Torrent, Emcure, Alkem from selling a medicine used for prevention and treatment of thromboembolic diseases, the patent for which is held by Bristol-Myers Squibb (BMS) as it filed its claims for patent infringement of Apixaban in Delhi HC. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 10, 2020 Category: Pharmaceuticals Source Type: news

Solara Active Pharma to conduct internal probe on Nizatidine API amid Mylan recall
"We understand from Mylan NV's press release dated January 8, 2020, that Mylan Pharmaceuticals has initiated a voluntary recall of three lots of Nizatidine Capsules, USP (150 mg and 300 mg strengths) due to detected trace amounts of impurity...," Solara Active Pharma Sciences in a filing to BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 9, 2020 Category: Pharmaceuticals Source Type: news

Revised NLEM to classify antibiotics by usage
New advice differentiating common antibiotics from those to be used for most serious medical conditions is likely in the revised National List of Essential Medicines. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 9, 2020 Category: Pharmaceuticals Source Type: news

Sun Pharma eyes China, Japan markets
Shanghai now plans to steer the company into the specialty business (novel, innovative drugs), and towards expanding markets like China and Japan for growth, both through acquisitions and partnerships. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 8, 2020 Category: Pharmaceuticals Source Type: news

Top cancer drugs may come under price control
Taking cue from the WHO ’s revised list of essential medicines, popular biosimilars for cancer cure may get incorporated in India’s revised National List of Essential Medicines. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 7, 2020 Category: Pharmaceuticals Source Type: news

Biocon elevates M B Chinappa as CFO of biosimilar subsidiary
M B Chinappa, who is going to play an important role in Biocon Biologics ’ journey towards becoming a global leader in biologics, has been tasked to drive financial performance of the company and improve profitability and manage anticipated risks in the journey of achieving the $1 billion revenue target in FY22, said the company in a press release. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 6, 2020 Category: Pharmaceuticals Source Type: news

Aurobindo Pharma Inc recalls Mirtazapine tablets in US
The product is being recalled due to a label error on declared strength. Bottles labelled as Mirtazapine 7.5 mg may contain 15 mg tablets, as per the company's announcement posted on the website of the United States Food and Drug Administration (USFDA). (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 2, 2020 Category: Pharmaceuticals Source Type: news

Soon, interest subsidy on loans for pharmaceutical infrastructure, technology upgrades
The Department of Pharmaceuticals proposes to bear 6% of the interest on loans up to Rs 8-10 crore for three years, through a public sector financial institution to be selected after open competitive bidding. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 31, 2019 Category: Pharmaceuticals Source Type: news

Dr Reddy's launches generic hypotensive injection in US
Drug firm Dr Reddy's Laboratories on Monday said it has launched in the US Sodium Nitroprusside injection used for immediate reduction of blood pressure in hypertensive crises. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 30, 2019 Category: Pharmaceuticals Source Type: news

2020: Indian pharma 'sunrise' segment, prognosis positive for healthcare sector
The next wave of growth could come from increasing exports to large and traditionally under penetrated markets such as Japan, China, Africa, Indonesia, and Latin America, which would help the industry meet its aspiration of becoming the world's largest supplier by volume, according to pharma industry body Indian Pharmaceutical Alliance (IPA). (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 28, 2019 Category: Pharmaceuticals Source Type: news

Zydus Cadila in talks to sell two units for Rs 1,200 crore
This is part of a broader strategy to reduce debt in the company ’s capital structure after it borrowed more to help finance the Rs 4,600-crore acquisition earlier this year of Heinz India’s consumer wellness business. Zydus has approached larger rivals, such as Cipla and Sun Pharmaceutical Industries, besides financial investors. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 27, 2019 Category: Pharmaceuticals Source Type: news

Department of Pharmaceutical asks industry to regulate promotional practices
The DoP secretary has told both the domestic and multinational pharma lobby groups along with the medical device industry to “strictly” comply with the code of ethics, added the same people. The pharma lobby groups and the medical devices lobby group have been asked to share their comments on the issue within a week. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 25, 2019 Category: Pharmaceuticals Source Type: news

GST profiteering: Rs 230-crore penalty on Johnson & Johnson
The authority said it found it ‘surprising’ that the FMCG major had not added the tax cost and losses to prices of products between July 1 and November 14, 2017, but had chosen to do so from November 15, when it was supposed to have reduced prices due to the rate reduction to 18% from 28%. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 25, 2019 Category: Pharmaceuticals Source Type: news

Exaggerated drug ads to bring fines, stringent charges
Ministry sets up panel to suggest stronger criminal procedures against violators. At present, penalties for false claims include “imprisonment which may extend to six months, fine, or both” in the case of the first conviction. In the case of a subsequent conviction, imprisonment “may extend to one year, or fine, or both”. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 24, 2019 Category: Pharmaceuticals Source Type: news

SGX gives RHT a year to take winding up call
Trustee-manager to plan new business satisfying Singapore Stock Exchange norms. Last month, the court questioned Fortis for using the Rs 4,600 crore to buy the assets from RHT. This had been done in a “hurried and clandestine manner” and is “required to be gone into,” the court had said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 24, 2019 Category: Pharmaceuticals Source Type: news

Glenmark Pharmaceutical Inc recalls ranitidine tablets in US
The tablets are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the United States Food and Drug Administration (USFDA), as per the company's announcement posted on the website of the US health regulator. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 22, 2019 Category: Pharmaceuticals Source Type: news

Natco launches cut price versions of cancer drug ibrutinib in india
The patent for the drug is held by Pharmacyclics for three to four more years in India. Pharmacyclics was globally acquired by US giant AbbVie in 2015 in a massive USD21 billion deal. Natco's latest move is consistent with its earlier launches and challenging the patents held on anti-cancer drugs by multinational drug companies. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 20, 2019 Category: Pharmaceuticals Source Type: news

Lupin gets USFDA nod to market skin ointment
The product will be manufactured at the company's Pithampur, Unit 3 facility, Lupin said in a filing to the BSE. The approval by the United States Food and Drug Administration (USFDA) is to market its generic Betamethasone Dipropionate ointment USP (augmented), 0.05 per cent, it added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 20, 2019 Category: Pharmaceuticals Source Type: news

Novartis announces gender-neutral insurance benefit plan for its employees
The coverage is also extended to children adopted through a legal process by employees, including single and same-sex LGBTI employees, the company said in a statement. The plan will be applicable with effect from January 1, 2020. The move, according to the company, "reaffirms its commitment towards Diversity and Inclusion" (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 20, 2019 Category: Pharmaceuticals Source Type: news

Panacea Biotec bags orders worth USD 24 mn from UN agencies
The vaccine protects children against five deadly diseases, including diphtheria, tetanus and hepatitis B. "Panacea Biotec... has received awards worth USD 24.32 million from U N agencies (Unicef and PAHO) for supply of its Easyfive-TT, a fully liquid WHO prequalified wP-based Pentavalent vaccine (DTwPHepB-Hib)," the company said in a filing to BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 19, 2019 Category: Pharmaceuticals Source Type: news

Violation of drug price control order: Drug cos under NPPA lens for self-exemption from price cap
Pricing watchdog has found that companies such as Lupin and Boehringer Ingelheim launched products bypassing the regulatory framework. The NPPA noted that these drug cos had launched anti-diabetes drugs under para 32 of the DPCO, without submitting the requisite application. This allows the NPPA to exempt certain classes of drugs from price control for a period of five years. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 16, 2019 Category: Pharmaceuticals Source Type: news

Glenmark's Baddi manufacturing unit receives GMP certificate from European regulator
Baddi manufacturing unit of Glenmark Pharmaceuticals was inspected by SUKL in the week of October 21 this year. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 16, 2019 Category: Pharmaceuticals Source Type: news

NPPA hikes 21 formulations ’ prices by 50%
The National Pharmaceuticals Pricing Authority (NPPA) invoked paragraph 19 of the Drug Prices Control Order to grant a 50% increase in the prices of 21 drug formulations. With the cost of raw material imported from China increasing 50-200%, pharma groups had approached the government to invoke extraordinary powers and increase the prices of drugs. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 14, 2019 Category: Pharmaceuticals Source Type: news

Food or drug? Government to take a call soon
Regulatory framework may be tweaked; move aims to determine the category of a product. Given the confusing proliferation of products, the government is looking to arrive at an answer by changing the regulatory framework. Most companies prefer to position their products as health supplements under the FSSA to avoid the more onerous D&C Act regime. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 13, 2019 Category: Pharmaceuticals Source Type: news

Biocon extends licensing pact with Equillium for itolizumab
Itolizumab, a first-in-class humanized anti-CD6 monoclonal antibody, is developed by Biocon and launched in 2013 in India under the brand name ALZUMAb to treat moderate to severe plaque psoriasis, a skin disease. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 12, 2019 Category: Pharmaceuticals Source Type: news

Pharma companies seek hike in drug rates under price control
Chinese API imports turn 200% costlier, making production costlier in India. Over 70% of the country ’s total bulk drug requirement comes from China. These bulk drugs or active pharmaceutical ingredients (API) are used in producing medicines, including essential items like antibiotics, vitamins and folic acid. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 12, 2019 Category: Pharmaceuticals Source Type: news

USV in talks with Novartis to buy Jalra Trademark for Rs. 200 Crore
Mumbai-based drugmaker USV Pvt Ltd is in advanced discussions to acquire the trademark for antidiabetes drug Jalra from Novartis for a deal valued at more than Rs. 200 crore. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 9, 2019 Category: Pharmaceuticals Source Type: news

SPV Foundation posts Rs 3 cr grant for bioscience research; TIFR scientist Vidita Vaidya bags research grant
Vidita ’s Neurobiology lab at TIFR currently studies the molecular, epigenetic and cellular changes that contribute to persistent alterations in human behaviour. It also focusses on molecular and cellular adaptations that arise from sustained antidepressant treatment. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 8, 2019 Category: Pharmaceuticals Source Type: news

Dr Reddy's Labs launches generic injection indicated for abortion in US
The company has launched Carboprost Tromethamine injection USP, 250 mcg/mL (1mL) single-dose vial in the US market, the pharma major said in a filing to BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 6, 2019 Category: Pharmaceuticals Source Type: news

Biocon sees a sweet spot with its affordable insulin in US
The biotech firm is also planning to provide its rh-insulin to middle- and low-income countries at less than 10 cents a day. Biocon Biologics is chasing a revenue target of $1 billion in financial year 2021-22. In the previous fiscal year, its revenue had topped $200 million. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 5, 2019 Category: Pharmaceuticals Source Type: news

Zydus Cadila files NDA for Saroglitazar Magnesium
NASH is a progressive disease of the liver and a significant unmet medical need. There are currently no treatments available for the treatment of NASH. aroglitazar Mg has previously demonstrated improvement in both liver enzymes along with favorable effects on lipid and glycemic indices in patients with nonalcoholic fatty liver disease in Phase II clinical trials. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 5, 2019 Category: Pharmaceuticals Source Type: news

Mankind Pharma launches drug for treatment of infertility in India
With the launch, the company has become the first Indian and second global firm to develop the drug, Mankind Pharma said in a statement. The company's product is generic version of Abbott's Duphaston tablets, it added. The manufacturing process of Dydrogesterone is very complex as it involves conversion of natural progesterone, the statement said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 5, 2019 Category: Pharmaceuticals Source Type: news

Central drugs regulator asks states, UTs to stop online sale of medicines
DCGI has asked all drug regulators in states and Union Territories to prohibit sale of drugs by online pharmacies. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 4, 2019 Category: Pharmaceuticals Source Type: news