Zydus managed to garner final nod from USFDA for Glyburide and Metformin Hcl

Ahmedabad based Cadila Healthcare has informed the BSE through a press release dated March 1, Tuesday stating that the pharma major has received final approval from the regulatory body USFDA for marketing Glyburide and Metformin Hcl Tablets USP in the strengths of 1.25/250;2.5/500; and 5/500 mg.  The drug is classified under the anti-diabetics segment and the company's formulations manufacturing site at Baddi, Himachal Pradesh, will manufacture the drug for the U.S. market.The group now has 103 approvals and till date has filed over 280 ANDAs (Abbreviated New Drug Applications) since the filing process commenced in FY 2003-2004.

Zydus Cadila Healthcare Limited (Zydus Cadila) is a globally recognised pharmaceutical company that, develops, discovers, markets and manufactures various healthcare products. The company’s product portfolio is inclusive of Active Pharmaceutical Ingredients (APIs), formulations, animal health products, and  cosmeceuticals. Its products are applied in the treatment of diseases related to cardiovascular disorders, women's healthcare, gastrointestinal disorders, respiratory, pain management,anti-infectives, central nervous system, cancer, and neurology, among others. Some of the leading brands of the company include Nutralite, EverYuth, Exemptia, Dermacare,Sugar Free, ActiLife, and others. Zydus Cadila operates a world-class research and development centre and has set up eight manufacturing plants to carry out its operations. It has operational presence with offices located across the US, Japan, Brazil, Europe, South Africa, and 25 other emerging markets.

The Key recent developments include - Aug 12, 2015: Zydus Cadila Q1 Net Profit up by 47% ; Jul 01, 2015: Zydus receives marketing authorisation for Morphine Sulfate ER tablets; May 15, 2015: Zydus Cadila’s Net Profit soars to Rs. 1151 crore; Apr 23, 2015: Zydus Group to Donate USD 240,000 to The National Institutes of Health, USA for Advancing Leishmaniasis Research; Feb 10, 2015: Zydus Cadila Net Profit up by 52% in Q3.

Inspectors from the US Food and Drug Administration (FDA) had visited the plant in January and came across significant violations from good manufacturing practices (GMP). Having reviewed Cadila’s response the FDA still had concerns about microbiology practices at the facility.

“We are concerned that trained microbiologists employed by your firm were unable to accurately identify microbial growth on environmental monitoring plates. Additionally, there is no assurance that such errors have not occurred previously”, was stated by the FDA in its warning letter to Cadila. The company has now taken satisfactory compliance measures and has received approval from USFDA.

Glyburide and metformin hydrochloride tablets, USP contain two oral antihyperglycemic drugs used in the management of type 2 diabetes, glyburide and metformin hydrochloride.

Recently, the group has launched Exemptia, the world’s first biosimilar for Adalimumab, the largest selling therapy worldwide for inflammatory arthritis. Zydus is also the only Indian pharma company to launch its very own patented NCE – Lipaglyn, which is the world’s first drug to be approved for the treatment of diabetic dyslipidemia.

The group’s origin can be traced to the year 1952 when it was founded by Late Mr. Ramanbhai B. Patel, who is a first-generation entrepreneur and a stalwart of the Indian Pharmaceutical Industry. In 1995, the group refurbished its operations and Cadila Healthcare came into being under the aegis of the Zydus group. Zydus Cadila, today, is spearheaded by Mr. Pankaj R. Patel, who is the chairman and managing director of the group.

From a meek turnover of Rs. 250 crores in 1995, the group has posted revenues of over Rs. 8600 crores in FY15. In the past the group had posted a turnover of Rs. 4600 crores in FY 11, that made it a billion dollar company. The company aims at becoming a leading global healthcare provider with a robust product pipeline and has ambitions of posting revenues of Rs. 10000 crore by 2015-16, and aspired to be a research-based pharmaceutical company by 2020.