ZIM Laboratories Ltd., a pharmaceutical company, focused on providing innovative drug delivery solutions that provide patient convenience and adherence to drug treatment, listed on the National Stock Exchange (NSE) at Rs. 336 per share.
The National Pharmaceutical Pricing Authority (NPPA) has revised the retail price of orally disintegrating strips of vitamin D3 manufactured by Zim Laboratories and marketed by Cadila Pharmaceuticals, after the latter approached the Authority with a review application.
On January 12, 2016, the Central Drugs Standard Control Organization (CDSCO) made available the minutes of the 15th Meeting of the Subject Expert Committee on Reproductive & Urology, held December 14, 2015, (15th SEC-Reproductive & Urology) at which proposals for clinical trials were reviewed. One of the Subsequent New Drug proposals reviewed by the committee involved a request for a Phase IV Clinical Trial Waiver by the Hyderabad-based Nu Therapeutics Private Limited for its Sildenafil Citrate 25 mg & 50 mg Orally Disintegrating Strips (ODS) drug product for the “treatment of erectile dysfunction”. The committee outright rejected the company’s request and noted that the manufacturing license granted on July 5, 2013 was subject to conducting a Phase IV Clinical Trial within one (1) year of receiving the approval from the Drug Controller General of India (DCGI). Accordingly, the company was given another two (2) months to file a protocol for a Phase IV Clinical Trial for this novel dosage form.