INDIA – Alkem Laboratories Limited, an Indian multinational pharmaceutical company, denied claims that batches of its products, Pan-D and Clavam 625, are not of standard quality adding that those samples were fake.

India’s drug regulator, which releases a monthly list of substandard or fake medicines sold in the country, said it found more than 50 drugs, including some batches of widely used antacids and paracetamol, “not of standard quality”.

Alkem said it investigated the claims by comparing the Central Drugs Standard Control Organisation’s (CDSCO) samples and the actual batches of both products and found that the CDSCO’s samples were not manufactured by the company.

The lab said it has already submitted a response to the CSDCO, along with the assessment report which confirmed that samples collected by CDSCO are spurious and not manufactured by Alkem.

“Alkem remains committed to following the highest quality standards and the current good manufacturing practices (cGMP) for all its products,” the press release noted.

“To tackle the spurious drugs issues, Alkem has incorporated unique features and QR codes in its packaging of both Pan-D and Clavam 625, which separates the genuine products from the spurious ones.”

Alkem is the fifth largest pharmaceutical company in the Indian market with a dominant position in the therapy areas of anti-infectives, gastrointestinal, pain management drugs and supplements.

It also has a portfolio of products in chronic therapies such as diabetes, neurology, cardiology, dermatology and urology.

The company has 19 state-of-the-art manufacturing facilities and cutting-edge research and development (R&D) centers across India and the US to develop and manufacture generic formulations, active pharmaceutical ingredients (APIs) and biosimilars.

Apart from India, the company has meaningful presence in the US, Latin America, Australia and several Asian countries.

Alkem Laboratories has launched the next-generation molecule, Vonoprazan in India under the brand name Vonzai. Vonzai will be launched under its newly established Gastrokem division.

 In a non-exclusive patent licensing with Takeda, Alkem aims to bring this novel treatment to the Indian market.

Vonzai tablets containing Vonoprazan are available in two dosage strengths: 10 mg and 20 mg. Vonoprazan fumarate has been approved by DCGI for the treatment of reflux esophagitis (RE), gastric ulcers and duodenal ulcers.

Studies indicate that P-CABs can help to bridge current therapeutic gaps through their longer half-life, greater effectiveness against nocturnal acid breakthrough and meal-independent dosing.

Unlike conventional therapies, P-CABs are acid-stable, do not require an enteric coating, and act immediately on proton pump, eliminating the need for pre-meal dosing. Vonoprazan is rapidly absorbed, reaching peak plasma concentration within two hours, and provides prolonged acid suppression. 

 

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