Indian health authorities have halted all production at the main factory of Maiden Pharmaceuticals near New Delhi after its cough syrups were linked to the deaths of dozens of children in Gambia.
Anil Vij, the home minister of India's northern Haryana state, said authorities inspected the Maiden facility four times this month and found 12 violations of good practices.
Maiden Pharma sells its products domestically as well as exports to countries in Asia, Africa and Latin America.
"Keeping this in view, the entire production of the company has been banned and notice has also been issued," Vij said.
Maiden Pharma has two other manufacturing plants in Haryana state.
What is the drug company accused of?
The World Health Organization (WHO) released a report last week saying that cold and cough syrups manufactured by Maiden Pharma may be linked to the deaths of at least 66 children in Gambia.
The WHO said that laboratory analysis of four Maiden products showed they had "unacceptable" amounts of potentially life-threatening contaminants that can seriously damage kidneys.
The Gambian health minister, Ahmadou Lamin Samateh, said over the weekend that the number of children who died from severe kidney damage had risen to 69.
The WHO also issued a medical product alert last week, asking regulators to remove the Indian company's goods from the market.
The drug company's director has denied the accusation to the Indian press.
The Gambian police, in a preliminary investigation report on Tuesday, said that the children's deaths from kidney damage were linked to cough syrups made in India, without naming the company.
Police added that the medicinal syrup was imported via a US-based company.
India's Health Ministry said last week it was informed about the WHO findings last month and it was waiting on results of tests of all four Maiden products from a federal laboratory.
India was not licensed to sell the drug domestically, but was only allowed to export them to Gambia, the Indian Health Ministry added.