Cipla recalls its bladder treatment drug in the US following regulatory deviations

INDIA – India’s drug giant, Cipla has been forced to recall close to 7300 bottles of its bladder therapy drug Solifenacin Succinate tablets, in the US market following “a manufacturing disparity that was not in line with current Good Manufacturing Practices (cGMP)”.

The recalled batches were produced at the company’s Goa-based plant and later shipped to its New Jersey-based arm Cipla USA.

Cipla initiated the recall on June 10 this year and the USFDA has classified it as a Class II recall, usually initiated in a situation in which use of, exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

This will become the second recall the company has done, back in January it recalled over 580000 packets of a drug for the reduction in the occurrence of gastric ulcers from the US market.

Despite the recall issues, Cipla boasts as one of the largest generic drug makers with over 1,500 products in 65 therapeutic categories available in over 50 dosage forms.

Its portfolio scope can further be narrowed down into generic & branded generics, specialty drugs and consumer health.

Generic and branded generic

Cipla’s generic business in India has contributed to 19% of the domestic pharmaceutical revenues with 4,000+ partners covering the entire country.

Despite competitive pressures and on-going regulatory challenges, the business delivered strong growth in the year under review and continued its leadership position in the market.

The company is focusing on strengthening it tier 3 & 4 towns by expanding its generic product portfolio to cater for patient’s needs.

Specialty

Cipla has for the last two years been focusing on establishing it engine 2.0 of growth based on the foundation of innovation and specialty medicine.

Its focus has been to establish a franchise of specialty medicines in the areas of Respiratory, CNS and Critical Care with a focus to build Institutional Specialty business.

The operations of a Specialty focused company differ significantly from the operations of a generic company and hence to establish a robust business model, Cipla Technologies LLC (CipTec) has been established with its headquarters in San Diego, California.

This also gives the Company ability to participate and operate in the biotech and life sciences innovation hub in the US.

Consumer health

With a vision of becoming the most preferred consumer healthcare company in India, Cipla Health Limited (CHL) (a Cipla subsidiary) has focused on driving innovation and simplifying healthcare by creating solutions which address unmet consumer needs and seamlessly mesh in their lifestyle.

Nicotex, its flagship smoking cessation brand, is the undisputed market leader in its category and has supported thousands of smokers on their journey of quitting smoking.

ActivKids ImmunoBoosters, a kids’ nutritional supplement in chocolate format, became the first Cipla product to be available in modern trade (such as Big Bazaar, D Mart, Reliance, Spencers, Tesco), e-commerce (such as Amazon, Flipkart, Big Basket) high end grocers, B2B channels (Walmart C&C, Metro C&C, Reliance B2B).

It has also partnered with Kidzania, a kids’ edutainment property active in Mumbai and Delhi with a permanent establishment to generate aided trials.

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