Germany-based Humana Milchunion eG, one of the largest baby food products and therapeutic multivitamins manufacturers, will soon foray into India and neighbouring markets in a big way.
The notice says the company can restart manufacturing these products only after the authority approves their revised formulation sheets.
The Indian major is eyeing German Merck's generic drug business.
Data exclusivity provides protection to the technical data generated by innovator companies to prove the merit of usefulness of their products.
They said 37.5 crore of Covishield doses from the Serum Institute of India and 28.5 crore Covaxin doses from Bharat Biotech will be procured by December.
These brands belong to about 320 drugs of leading Indian pharmaceutical companies. The Drug Controller General of India's (DCGI's) office feels that these have been launched without its approval.
The company claimed that the AYUSH ministry has "categorically agreed" that Patanjali had "appropriately worked on COVID-19 management".
Several firms are stepping up to help their workforce cope with soaring temperatures
Legal experts and official sources said the alleged submission of fake documents can also lead to criminal charges against Novartis.
While the opposition party asked the government to stop boasting about India being a pharmacy to the world and take strictest action, the ruling party accused it of deriding India in its "hate" for Prime Minister Narendra Modi.
Netmed plans to procure from drug manufacturers and sell to pharmacies it has tie-ups with, and to spread its network to all tier-II and tier-III cities.
Strides Arcolab Ltd's, US subsidiary Strides Inc and STADA Pharmaceuticals Inc, the US subsidiary of STADA Arzneimittel AG, have signed a development and supply agreement for a prescription generic drug product for the US market.
Ranbaxy Laboratories on Friday said it had received approval from US Food and Drug Administration to manufacture and market nitrofurantoin monohydrate macrocrystals capsules (100 mg) and planned to bring the new drug to the market in April.
The United States Food and Drug Administration has given tentative approval to the fixed-dose combination drug products lamivudine and zidovudine tablets -- manufactured by Aurobindo Pharma Ltd.
National security advisor Ajit Doval on Friday suggested that various central armed police forces of the country should have "jointness" and interoperability among themselves like the ongoing plan for the defence forces.
Apollo Pharmacy, the country's largest branded drug retail network with over 1,500 outlets, has temporarily suspended sale of medicines manufactured by Ranbaxy Laboratories. It has also stopped further procurement from the company for now.
The Supreme Court on Tuesday tore into Patanjali Ayurved's defence for putting out misleading advertisements, rejecting the apology from yoga guru Ramdev and the firm's managing director Acharya Balkrishna as 'lip service' and warned them against perjury.
Industry is gathering scientific data to approach the regulator, DCGI, for a review of the suspension order.
In a reversal of its two-year-old decision to avoid from the purview of the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, the finance ministry, which administers the Act, has once again proposed compulsory registration of all medicine manufacturers and dealers that handle drugs that contain narcotic and psychotropic substances before the Central Bureau of Narcotics (CBN). CBN comes under the revenue department of the ministry.
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The Drugs Controller General of India is considering the recommendations of its advisory body to revoke the suspension of the sale of analgin-based medicines in the country.
Several companies, including Indian units of Abbott Laboratories and Pfizer Inc, and domestic firms like Cipla Ltd and Macleods Pharmaceuticals, went to the Delhi High Court to try to get the ban lifted.
Ranbaxy Laboratories on Monday said it has received tentative approval from the United States Food and Drug Administration to manufacture and market anti-hypertension drug Quinapril Hydrochloride in the US.
The company has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules in 30 mg and 90 mg strengths from the United States Food and Drug Administration (USFDA), Lupin Ltd said in a statement.
Weak scientific capabilities, lack of desire to advance knowledge, and regulatory uncertainty are some of the hurdles Indian drug companies face, says Chirantan Chatterjee.
Indian drug maker Alembic Ltd plans to expand its bulk drugs business in the United States by joining hands with US formulations makers, the Bombay Stock Exchange said on Thursday.
Food and Drug Authority Ghana said in a statement that officials of Bliss GVS Pharma of India and Ghanaian drug maker Tobinco Pharmaceuticals have apologised to it for importing 'fake malaria medicine' to Ghana to treat malaria in children.
As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
Roadblocks ahead as these medicines could face new clinical tests, more scrutiny
Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.
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The company has launched the Decitabine for injection in the strength of 50 mg in the US market following approval by the United States Food & Drug Administration of Dr Reddy's abbreviated new drug applications, it said in a statement.
A bench comprising Chief Justice Ranjan Gogoi and Justice Deepak Gupta held the former Ranbaxy promoters guilty of contempt of court and said that they had violated its earlier order by which the sale of their controlling stakes in Fortis Group to Malayasian firm IHH Healthcare was put on hold.
Though there is no official word, the sources said the government is not ready to give in to the indemnity demands of the US drug manufacturers against liabilities in case of adverse effects.
Pulse oximeters, hand sanitisers, temperature check equipment and ambulances too will attract lower 5 per cent tax.
In two separate affidavits filed in the apex court, Ramdev and Balkrishna tendered unqualified apology for the 'breach of the statement' recorded in the November 21 last year order of the apex court.
Dr Reddy's on Monday said it would acquire Switzerland-based Roche's bulk drug business in Mexico for $59 million.
To keep price control to a minimum, the government can act in two areas where it has not done so far.
