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FDC DRUGS
USFDA issues Form-483 with 5 observations to Ajanta Pharma's Paithan facilityAjanta Pharma said the US FDA has issued Form-483 with five observations after inspecting its Paithan manufacturing facility in Maharashtra...- India’s drug regulator flags 90 unapproved FDCs, directs states to take actionIndia's drug regulator has initiated a nationwide crackdown on unapproved fixed-dose combination drugs. At least 90 such medicines have bee...
- 29 vitamin-mineral FDC drugs under review for possible ban over 'irrational' tagA looming ban on twenty-nine vitamin and mineral combination drugs has sparked a heated debate. Initially flagged as irrational by an exper...
- In major development in pharma, halt order enforced on production and sale of 35 fixed-dose combination drugsIndia's drug regulator, CDSCO, has ordered a halt to the production, sale, and distribution of 35 fixed-dose combination (FDC) drugs due to...
- Govt bans anti-cold fixed drug combination for under-four childrenThe matter was deliberated in the Subject Expert Committee (SEC- Pulmonary) meeting held on June 6. "The committee recommended that the FDC...
- Lens on fixed-dose combination drugs containing vitamins, mineralsA committee had been set up under the chairmanship of CK Kokate, former vice-chancellor of KLE University, Belgaum, to review the safety, e...
- Govt bans 14 fixed dose combination drugs, cites they may involve risk to peopleThe expert committee said that there is "no therapeutic justification for this FDC (fixed dose combination) and the FDC may involve risk to...
- FDC launches stronger versions of its generic Covid drug, Favipiravir, in IndiaThese prescription-only drugs will be available at all retail medical outlets and hospital pharmacies across the country, from November 1, ...
- FDC launches 2 variants of Favipiravir in India at Rs 55 per tabletNew Delhi, Aug 25 () Drug firm FDC Ltd on Tuesday said it has launched two variants of the COVID-19 drug Favipiravir under the brand names ...
- Government notifies over 450 Fixed-Dose Combination drugs as 'rational'An FDC drug contains two or more active ingredients in a fixed dosage ratio. The drugs are deemed rational when claims for their benefits a...
- Hetero launches FDC combination of key HIV drugsThe FDC drug ‘Darunavir+Ritonavir’ is an anti-retroviral medication indicated for the treatment of human immunodeficiency virus (HIV-1) in ...
- Govt challenges revocation of FDC drug ban in Supreme CourtThe petition comes almost two months after the Delhi HC on December 2 set aside the govt notification that had banned hundreds of fixed dos...
- Government targets 500 combination drugs, confrontation with pharma companies loomingAccording to a person familiar with the development, the central drug regulator has sent letters to nearly 300 companies, which have sought...
- Pharma sector grows 7.7 per cent in May; FDC ban weighsUnder the non-NLEM category, growth in May for domestic players and MNCs almost doubled to 9 per cent and 7.1 pc as against April's 4.6 pc ...
- HC reserves verdict on pleas against ban on 344 FDCsThe court had on March 14 stayed the Centre's ban on 344 FDC drugs and this interim order was passed in each and every case filed before it...
- Delhi HC stays ban on drugs of Wockhardt, Glaxo and GriffonThe court also issued notice to the government on the companies' pleas challenging the notification and listed the petitions for hearing on...
- Cipla's anti-malaria drug receives WHO pre-qualificationCipla today said an anti-malarial drug developed by Drugs for Neglected Diseases initiative (DNDi) has received pre-qualification from WHO.
- Over 44 fixed-dose combination drugs clear DGCI testsThe government may give permission to 44 more combination drugs - a formulation of two or more active ingredients combined in certain fixed...
- Drug cos, govt set up panels to decide on combo drugsDrug companies and the govt have formed separate technical committees to jointly decide which of the 294 combination drugs can be phased ou...
- Allow fixed drug combos for now: IPADomestic pharma industry representative Indian Pharmaceutical Alliance (IPA) has asked the government to allow drug companies to sell fixed...
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