Brazil: Overview of API registration

Regulatory Affairs in Latin America

In Brazil, the health authority (ANVISA) will require that all Active Pharmaceutical Ingredients (APIs) manufactured in Brazil, imported for manufacturing of drug products, or included in imported finished products, are registered with the agency.

This regulation has been put in place in 2009, and the implementation has been gradual: ANVISA created a scheme that includes the different API categories in different “waves” of implementation.

In the first implementation wave (deadlines to register in 2010) the following drug substances were included: Cyclosporine, Clozapine, Clindamycin Chlorhydrate, Ciclophosphamide, Ciprofloxacin, Methotrexate, Carbamazepine, Lithium Carbonate, Phenytoin, Sodium Phenytoin, Lamivudine, Penicillamine, Thiabendazole, Efavirenz, Nevirapine, Rifampicin, Ritonavir, Zidovudine, Acyclovir and Ampicillin.

In June 2013, the second implementation wave was announced, including the following substances: Azithromycin, Benzylpenicillin, Cabergoline, Carboplatin, Cephalexin, Cephalothin, Ceftazidime, Cisplatin, Clarithromycin, Ceftriaxone and their respective salts, esters, ethers and hydrates, and the salts, esters, ethers and hydrates of the APIs included in the first…

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Bristol-Myers Squibb announced promising results from an expanded phase 1 dose-ranging study of its lung cancer drug nivolumab

New Drug Approvals


Anti-PD-1;BMS-936558; ONO-4538

PRONUNCIATION nye vol’ ue mab
THERAPEUTIC CLAIM Treatment of cancer
A fully human IgG4 antibody blocking the programmed cell death-1 receptor (Medarex/Ono Pharmaceuticals/Bristol-Myers Squibb)

SPONSOR Bristol-Myers Squibb

Bristol-Myers Squibb announced promising results from an expanded phase 1 dose-ranging study of its lung cancer drug nivolumab

Nivolumab (nye vol’ ue mab) is a fully human IgG4 monoclonal antibody designed for the treatment of cancer. Nivolumab was developed by Bristol-Myers Squibb and is also known as BMS-936558 and MDX1106.[1] Nivolumab acts as an immunomodulator by blocking ligand activation of the Programmed cell death 1 receptor.

A Phase 1 clinical trial[2] tested nivolumab at doses ranging from 0.1 to 10.0 mg per kilogram of body weight, every 2 weeks. Response was assessed after each 8-week treatment cycle, and were evaluable…

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FDA In India: Going Global, Coming Home, Altaf Ahmed Lal, Ph.D. is the Director of FDA’s office in India.

New Drug Approvals


Altaf Ahmed Lal, Ph.D. is the Director of FDA’s office in India.

By: Altaf Ahmed Lal, Ph.D. 

What is it like to be starting my new position as director of FDA’s office in India?

It’s like coming home.

My new tenure at FDA began in June, but as a former health attaché in the U.S. Embassy, I played an enthusiastic role in helping to establish FDA in my native country.  I was born in Kashmir, India, and though I left the country in 1980 to explore new professional opportunities in the United States, I have since been drawn back again and again.


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Founder of leading Indian pharmaceutical company, Sun Pharmaceuticals has been named India’s third richest man

New Drug Approvals


This is the first time Mr Dilip Shanghvi, founder of Sun Pharmaceutical has been named in the top three with a 66 percent surge in his wealth –

25 oct 2013

Singapore: For the first time, founder of leading Indian drugmaker Sun Pharmaceuticals, Mr Dilip Shanghvi has been named in the top three of India’s richest men. Mr Shanghvi has made an appearance in the list prepared by China based ‘Hurun India Rich List’ as the third richest Indian man with a 66 percent surge in his wealth. Energy tycoon and Reliance Industries chairman Mr Mukesh Ambani has topped the list as India’s richest man with personal assets of $18.9 billion, news reports mentioned. The report pointed out that Mr Ambani has retained the top position for the second year even after a wealth decrease of two percent. London-based steel baron Mr Lakshmi Narayan Mittal has been named the second…

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FDA approves second brain imaging drug Vizamyl (flutemetamol F 18 injection)to help evaluate patients for Alzheimer’s disease, dementia

New Drug Approvals

  is the structure on right

Vizamyl (flutemetamol F 18 injection) get structure


Chemical name:2-{3-[18F]fluoro-4-(methylamino)phenyl}-1,3-benzothiazol-6-ol    diagnostic aid
Cas Number765922-62-1
INN  nameflutemetamol
Molecular Formula:

GE Healthcare


For Immediate Release: Oct. 25, 2013

The U.S. Food and Drug Administration today approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer’s disease (AD) and dementia.

Dementia is associated with diminishing brain functions such as memory, judgment, language and complex motor skills. The dementia caused by AD is associated with the accumulation in the brain of an abnormal protein called beta amyloid and damage or death of brain cells. However, beta amyloid can also be found in the brain of patients with other dementias and in elderly people without neurologic disease.

Vizamyl works by attaching to beta amyloid…

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loteprednol etabonate…Patent expiry this week……of October 20, 2013

New Drug Approvals

loteprednol etabonate

82034-46-6 cas

Drug Patent Expiry for the week of October 20, 2013




Generic Name………loteprednol etabonate

Patent No.US 5,540,930

The invention provides novel compositions of matter containing water-insoluble steroid drugs suitable for therapeutic use. The invention provides stable aqueous suspensions of water-insoluble steroid drugs of particle sizes of ≦15 μm which remain in such a state so as to allow for immediate suspension, when desired, even after extended periods of settling.

Approval History
DateSupplement No.ActionDocuments

Publication numberUS5540930 A
Publication typeGrant
Application numberUS 08/142,743
Publication date30 Jul 1996
Filing date25 Oct 1993
Priority date25 Oct 1993
Fee statusPaid
Also published asCA2174550A1, CA2174550C, DE69430635D1, DE69430635T2, EP0730443A1, EP0730443A4, EP0730443B1, US5747061, WO1995011669A1, Less «8 More »
Publication number

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