CGMP refers to the Current Good Manufacturing Practice regulations enforced by the USFDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.

Granules USA, Inc., a wholly-owned foreign subsidiary of the company located in New Jersey, NY, has recalled one batch has 11.4 million units of naproxen tablets out of which 0.9 million units that were released into the market.

Financially, this does not have a material impact on the company, Granules India said in a statement.

G. N. Prashanth, senior vice president & head- corporate quality assurance - Granules India, said: Granules manufactured and released a batch using active pharmaceutical ingredient (API) from an alternate source prior to the final approval of a filed prior approval supplement. We have since received the authorization to use the API for this ANDA. There was absolutely no harm done at a patient level because the API used in the batch is from an FDA approved source.

Granules has not received any reports of adverse event that have been confirmed to be directly related to this recall as of the date.

Granules India is a vertically integrated fast growing Indian pharmaceutical company headquartered at Hyderabad. It is present in the manufacturing of entire value chain - from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). The company's products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 75+ countries with offices across India, U.S. and U.K.

The drug company posted a 7.9% rise in consolidated net profit to Rs 120.2 crore on a 15.5% increase in net sales to Rs 849 crore in Q1 FY22 over Q1 FY21.

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Granules India in a response towards certain media articles announced that Granules USA, Inc., a wholly-owned foreign subsidiary of the Company located in New Jersey, NY, is voluntarily recalling one batch of Naproxen Sodium 220mg tablets at a retail level due to a minor “CGMP deviation”. One batch has 11.4 million units of Naproxen tablets out of which 0.9 million units that were released into the market were recalled. Financially, this does not have a material impact on the Company.

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Developed by DRDO, 2-DG has been granted permission by Drug Controller General of India (DCGI) for emergency use of this drug as adjunct therapy in moderate to severe Covid 19 patients.

2-DG works by accumulating in virus infected cells and prevent growth of the virus by stopping - energy production and viral synthesis. This drug reduces a patient's average recovery time by two and half days and oxygen demand by up to 40%.

Granules is working closely with DRDO team to launch the product in India at the earliest.

Granules India along with its subsidiaries has a global presence which extends to over 250 customers in over 75 countries through its offices in India, US & UK and has seven manufacturing facilities out of which six are located in India and one in the USA.

The drug company posted a 7.9% rise in consolidated net profit to Rs 120.2 crore on a 15.5% increase in net sales to Rs 849 crore in Q1 FY22 over Q1 FY21.

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Granules India has received marketing approval from Health Canada for Acetaminophen Extended-Release Tablets OTC, 650mg for the treatment of Arthritis Pain. The product manufactured by Granules is a bioequivalent to the reference listed drug, Tylenol® Extended Release 650 Tablets.

The drug will be manufactured at the Granules manufacturing facility located in Gagillapur, Hyderabad. Granules now have a total of 2 ANDS approvals from Health Canada.

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