Cipla (EU) Ltd.

InvaGen, a unit of Cipla, issued a voluntary recall of one lot of the oral anti-seizure drug vigabatrin due to problems with seal integrity in its packaging. Cipla subsidiary InvaGen issued a voluntary recall of one lot of the oral anti-seizure drug vigabatrin due to problems with seal integrity in its packaging. The recalled lot of the medication, which is typically used to treat infantile spasms and refractory complex partial seizures, is NB301030 with an expiration date of March 2025. The medicine was distributed nationwide in the U.S. In a notice posted on the FDA website, the company said a faulty seal in the pouch could lead to the powder leaking from the pouch, plus the potential for patients to be underdosed. “In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention,” the company said. “For a small minority of patients, who might have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in life-threatening seizures requiring immediate emergency room treatment.” To date, Cipla said there have been no reports of adverse events related to the recall. Just two weeks ago, Cipla was slammed with a warning letter that outlined a number of ongoing issues with the company’s manufacturing facility in Pithampur, India, which was the target of a Form 483 earlier this year. In its warning letter, the regulatory agency cited three major failures that led to other problems at the facility, which was inspected between February 6 and February 17 of this year.

HAUPPAUGE, N.Y., Dec. 9, 2023 /PRNewswire/ -- Cipla Limited today announced that its wholly-owned subsidiary, InvaGen Pharmaceuticals Inc. is voluntarily recalling one lot of Vigabatrin for Oral Solution, USP 500mg, to the consumer level. Vigabatrin for Oral Solution, USP 500 mg has been found to have seal integrity issues allowing for powder leakage from the pouch. An improper seal in the pouch may lead to the leakage of powder blend outside the pouch, resulting in a lower content of medicine inside the pouch compared to the label claim and result in potential underdosing. The population at risk is primarily infants and young children. In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention. For a small minority of patients, who might have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in life-threatening seizures requiring immediate emergency room treatment. Cipla has not received any reports of adverse events related to this recall. The product is used for the treatment of Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded adequately to several alternative treatments. Vigabatrin for oral solution is not indicated as a first-line agent. The medication is packaged in foil pouches, each containing 500mg of Vigabatrin, and there are 50 foil sealed pouches in a shelf pack. The affected lot is NB301030, with an expiration date of 03/2025. The Vigabatrin for Oral Solution, USP 500mg product was distributed nationwide to partnered distributors and consignees. InvaGen Pharmaceuticals is notifying the customer level through press releases, letters, telefax, telephone, email, and on-site visits, and is coordinating the return of all recalled products. Distributors, retailers and consumers in possession of Vigabatrin for Oral Solution, USP 500mg Batch No. NB301030, NDC# 6909-7964-53 are advised to initiate the return process through their respective place of purchase. Consumers with questions regarding this recall can contact Cipla by phone number 844- CIPLAUS (844-247-5287) M-F 8:30 AM-5:00 PM EST, or email [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this batch of drug product. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: Regular Mail or Fax: Download the form at or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. DISCLAIMER Cipla maintains stringent quality processes to assess quality defects and safety issues. Cipla conducts regular investigation and assessment by committees consisting of subject-matter experts, quality management, and medical safety experts. SOURCE Cipla USA

MUMBAI, India and MUNICH, Germany, Dec. 29, 2022 /PRNewswire/ -- Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) referred to as "Cipla" today announced that its wholly-owned UK subsidiary, Cipla (EU) Limited ("Cipla EU") has signed definitive agreements for equity investment of EUR 15 million in Ethris GmbH ("Ethris"), a global leader in delivering mRNAs directly to the respiratory system including administration by inhalation. The investment will facilitate a long-term strategic partnership between Cipla and Ethris for the development of messenger RNA (mRNA)-based therapies and fast-track Cipla's participation in the mRNA space, enabling it to provide access to cutting-edge solutions developed by Ethris for the developing countries. A collaboration agreement is signed concurrently with the definitive agreement, which paves a path to market Ethris' innovative portfolio in Cipla's key emerging markets. The transaction is expected to get completed within 60 days from the date of signing of the agreement or such other time-period as may be mutually agreed between the parties in writing and shall be subject to completion of necessary regulatory formalities. Umang Vohra, Managing Director & Global Chief Executive Officer of Cipla, said: "This collaboration accelerates our innovation journey and enables us to provide access to cutting-edge healthcare solutions to our patients. We expect mRNA-based therapies to be one of the key innovation levers for Cipla. This inhaled mRNA technology is a paradigm shift in the delivery mechanism and this partnership reinforces Cipla's strength in respiratory therapy in line with our aspiration of attaining global lung leadership." Dr. Carsten Rudolph, CEO of Ethris stated: "We value this strategic relationship with Cipla that will build on our pioneering mRNA technology and our joint focus on bringing innovative treatments for respiratory diseases to patients. The investment supports the further development of our pipeline and our objective to leverage the power of mRNA-based therapeutics to treat a broad range of diseases." About Cipla: Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 47 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 86 markets. Cipla is the 3rd largest in pharma in India (IQVIA MAT November '22), 3rd largest in the pharma private market in South Africa (IQVIA MAT October '22) and is among the most dispensed generic players in the U.S. For over eight decades, making a difference to patients has inspired every aspect of Cipla's work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla's humanitarian approach to healthcare in pursuit of its purpose of "Caring for Life" and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn. About Ethris Ethris has paved a new path from genes to therapeutic proteins, using its proprietary messenger RNA technology platform to discover, design and develop innovative therapies. With more than a decade as an mRNA pioneer, Ethris is a global leader in delivering stabilised mRNAs directly to the respiratory system via optimised formulation and nebulisation technologies. The company is rapidly advancing its mRNA pipeline of immuno-modulation, protein replacement therapies, and differentiated vaccines against viral infections, with the ultimate goal of improving patients' lives. For more information, visit www.ethris.com Logo - https://mma.prnewswire.com/media/947146/Cipla_Logo.jpg SOURCE Cipla