The Food and Drug Administration (FDA) hereby advises the concerned licensed drug establishments and the general public that the list of compliant ranitidine-containing products relative to the levels of N-nitrosodimethylamine (NDMA) which are allowed to be sold is updated as follows:
| GENERIC NAME, DOSAGE STRENGTH AND FORM | BRAND NAME | REG. NO. |
| Ranitidine (as hydrochloride) 150 mg Tablet | Contracid | DRP-1237 |
| Ranitidine (as Hydrochloride) 150 mg Tablet | Radine | DR-XY32319 |
| Ranitidine (as hydrochloride) 150 mg Tablet | Ranae | DRP-1237-01 |
| Ranitidine (As Hydrochloride) 150 mg Film Coated Tablet | Ranitein | DRP-1857 |
| Ranitidine (As Hydrochloride) 150 mg Film Coated Tablet | Ratidin | DRP-1857-01 |
| Ranitidine Hydrochloride 150mg Film-Coated Tablet | Raxide | DR-XY26358 |
| Ranitidine 150 mg Film-Coated Tablet | Zilatec | DRP-4651 |
| Ranitidine (as hydrochloride) 300 mg Film-Coated Tablet | Alcera | DRP-4494 |
| Ranitidine (As Hydrochloride) 300 mg Film Coated Tablet | Ranitein | DRP-1851 |
| Ranitidine (As Hydrochloride) 300 mg Film Coated Tablet | Ratidin | DRP-1851-01 |
| Ranitidine Hydrochloride 300mg Film-Coated Tablet | Raxide | DR-XY30701 |
| Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) | Aciloc | DRP-869 |
| Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) | Aglotac | DRP-6135 |
| Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Solution for Injection | Alflux | DRP-7635 |
| Ranitidine Hydrochloride 25 mg/mL Solution for Injection | Ameket | DR-XY28707 |
| Ranitidine (as Hydrochloride) 25 mg/mL Solution for Injection (IM/IV) | Ameket | DRP-8324 |
| Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) | Amkodine | DRP-159-05 |
| Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) | Apo-tin | DRP-6304 |
| Ranitidine Hydrochloride 50 mg/2 mL Sterile Solution for Injection (IM/IV) | Contracid | DRP-655 |
| Ranitidine (as hydrochloride) 25 mg/mL Sterile Solution for Injection (IM/IV) | Danitin | DRP-1107 |
| Ranitidine (as hydrochloride) 25 mg/mL Sterile Solution for Injection (IM/IV) | Dynastin | DRP-1107-01 |
| Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) | Eastidine | DRP-869-01 |
| Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) | Effedine | DRP-159-03 |
| Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Solution for Injection | Entac | DR-XY29322 |
| Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) | Geoxer | DRP-159-06 |
| Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) | Hacidac | DRP-869-02 |
| Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) | Nelstac | DRP-7171 |
| Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) | Primudine | DRP-6304-01 |
| Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) | Qualran | DRP-159 |
| Ranitidine (as Hydrochloride) 25 mg/mL Solution for Injection (IM/IV) | Ranidex | DR-XY39911 |
| Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) | Ranipen | DRP-159-09 |
| Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) | Ranistar | DRP-7171-01 |
| Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection | Ranitein | DRP-2017 |
| Ranitidine Hydrochloride 25 mg/mL Solution for Injection | Raxide | DR-XY30531 |
| Ranitidine Hydrochloride 25mg/mL Solution for Injection (IM/IV) | Raxidine | DR-XY39368 |
| Ranitidine Hydrochloride 25 mg/mL Solution for Injection (IM/IV) | Siutec | DR-XY31808 |
| Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Solution for Injection (IM/IV) | Ulcin | DR-XY19686 |
| Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) | Westran | DRP-159-07 |
| Ranitidine Hydrochloride 25 mg/mL (50 mg /2 mL) Solution for Injection (IM / IV) | Zantol | DR-XY40614 |
| Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) | Zantricid | DRP-159-04 |
| Ranitidine Hydrochloride + Tripotassium Bismuth Dicitrate + Sucralfate 84 mg/100 mg/300 mg Film-Coated Tablet | Albis | DR-XY44001 |
| Ranitidine (As Hydrochloride) / Magnesium Aluminosilicate / Magnesium Aluminum Hydrate / Magnesium Oxide 28.227 mg/125 mg/100 mg/50 mg Film-Coated Tablet | Ranilex | DR-XY43504 |
However, for other registered ranitidine products for human use that are yet to submit their testing, the FDA Philippines maintains the following directives:
1. Suspension of all operations (i.e., manufacture, importation, exportation, distribution, offer for sale) of concerned establishments, e.g., Marketing Authorization Holders (MAH), manufacturers, importers, exporters, distributor/sub-distributor, dealing with ranitidine products excluding those in the retail level. Ranitidine products currently available in the retail outlets can still be consumed;
2. Strict utilization of either Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) as recommended by the US FDA for every registered ranitidine product showing the analyses, in available batches of both the drug substance/active pharmaceutical ingredient (API) and the finished product, to determine the presence of NDMA;
3. Submission of complete documents including the following:
a. Certificates of Analysis of API and Finished Product
b. Analytical Results
c. Analytical raw data including chromatograms/spectra
d. Other relevant data
4. Provision of these documents must be done by all affected MAHs/establishments within thirty (30) calendar days from issuance of this amendment through submission to both these email addresses: [email protected] and [email protected] containing the subject: Ranitidine-[Name of MAH/establishment]. A list of your registered ranitidine products with its registration numbers and the complete address of every API manufacturer/supplier must also be reflected in the body of your e-mail.
Resumption of operations of affected ranitidine products shall depend on the compliance of its MAH and non-submission of required documents shall lead to regulatory action/s without prior notice. Furthermore, the FDA Philippines shall still stringently monitor all ranitidine products under Post-Marketing Surveillance.
Dissemination of the information to all concerned is requested.