Chromo has a very strong track record in the regulatory filings. The following are our DMF filings.
CEPs:
S.No. | Name of the Product | Date of submission | CEP No. | Status |
1. | Candesartan Cilexetil | 05.12.2011 | CEP 2011-367 | Granted |
2. | Repaglinide | 07.03.2012 | CEP 2012-087 | Granted |
3. | Voriconazole | 30.05.2013 | CEP 2013-171 | Granted |
4. | Atorvastatin Calcium Trihydrate | 11.09.2015 | CEP-2015-288 | Granted |
5. | Moxifloxacin Hydrochloride | 22.12.2016 | CEP-2016-327 | U/Evaluation |
6. | Terbinafine Hydrochloride | 03.04.2017 | CEP 2017-102 | U/Evaluation |
US DMFs:
S.No. | Name of the product | Date of submission | DMF number | Status |
1 | CANDESARTAN CILEXETIL USP | 2/17/2012 | 25797 | Not reviewed |
2 | ZAFIRLUKAST PREMIX-50% W/W | 9/28/2012 | 26359 | Not reviewed |
3 | REPAGLINIDE USP | 9/10/2012 | 26396 | Reviewed |
4 | VORICONAZOLE USP | 6/22/2017 | 31709 | Not reviewed |
5 | TERBINAFINE HYDROCHLORIDE USP | 7/12/2017 | 31719 | Not reviewed |
6 | ZAFIRLUKAST | 8/18/2017 | 31869 | Not reviewed |
Certifications:
Chromo has the following certifications
S.No. | Certification | Issuing authority |
1. | USFDA-EIR | FDA |
2 | WHO GMP Certification | CDSCO-India |
3 | GMP Certification | Drugs controller- Telangana |
4 | EU Written confirmation | CDSCO-India |
5 | Mexico-GMP | COFEPRIS Mexico |
6 | ISO 9001-2008 | TUV Sud South Asia |