Gennex Laboratories Limited disclosed that its subsidiary company, Deccan Remedies Limited, has received regulatory approvals from the Drug Control Administration, Government of Andhra Pradesh for additional pharmaceutical products.
Commercial Manufacturing License (Form 25)
Deccan Remedies Limited received approval under Form 25, Drug Licence No. 31/VP/AP/2014/B/R/CC, dated November 14, 2014, valid until May 28, 2028. The approval covers manufacturing for both domestic and export purposes for the following six products:
1. Caffeine - Compliant with IP, BP, PhEUR, JP, USP standards
2. Duloxetine Hydrochloride - Compliant with IP, BP, PhEUR, USP standards
3. Mebeverine Hydrochloride - Compliant with IP, BP, PhEUR standards
4. Phenylephrine Hydrochloride - Compliant with IP, BP, PhEUR, JP, USP standards
5. Trimebutine Maleate - Compliant with IP, BP, PhEUR, JP standards
6. Oxyclozanide - Compliant with IP, BP, InHouse standards
Test License (Form 29)
Additionally, the company received a Test License under Form 29 valid for three years from the date of issue for the purpose of examination, test or analysis for the following four products:
1. Ranolazine - IH specifications
2. Cinnarizine - IH/Ph. Eur specifications
3. Sacubitril - IH specifications
4. Triclabendazole - USP/BP specifications
License Conditions
The approvals are subject to several conditions including:
- Specific permission for each export order not required, but export details must be furnished immediately after completion
- Detailed particulars of rejects/returned goods must be furnished to the authority
- Compliance with specifications/standards required by importing countries
- Fulfillment of federal regulations of importing countries
- Compliance with Drugs Price Control Order, 2013
- Conducting necessary stability studies
- Prevention of false/misleading claims and imitation of other drugs
- Compliance with all labeling provisions
- For narcotics/psychotropic drugs, additional approval from Narcotic Commissioner of India required