| 1 | GOODMAN AGENCIES LTD | 12459 | Otocol Ear Drops | Human | Foreign | Chloramphenicol and Benzocaine | 5 %, 5% | H2019/CTD6381/12459 | Ear Drops | OTHER | Recommended | 36 months | | S02AA | Otological Anti-infectives | Amman Pharmaceutical Industries | King Abdullah II Estate-Sahab, Amman 11512 | api@orange.jo | AMMAN PHARMACEUTICALS LTD | KING ABDUALLAH II INDUSTRIAL ESTATE, SEHAB P.O… | Registered | Valid |
| 2 | NAIROBI ENTERPRISES LTD | 17275 | ENDOPROST 125 MCG INJECTION | Human | Foreign | Each 1 ml Contains: Carboprost Tromethamine USP… | Each 1 ml Contains: Carboprost Tromethamine USP… | H2019/CTD4213/632ER | Injection | ORAL | Recommended | 36 months | | J01 | ANTIBACTERIALS FOR SYSTEMIC USE | Bharat Serums and Vaccines Ltd | Plot No. K-47, Anand Nagar, M.I.D.C, Ambernath… | ambernath@serums.com | BHARAT SERUMS AND VACCINES LIMITED (AMBERNETH) | PLOT NO. K-27, ANAND, NAGAR, ADDITIONAL MIDC,… | Registered | Valid |
| 3 | WESSEX PHARMACEUTICALS LTD | 17290 | OPTILIP 40 | Human | Foreign | ATORVASTATIN CALCIUM TRIHYDRATE | 40MG/TABLET | H2019/CTD6674/1008ER | Tablet | ORAL | Recommended | 24 months | A yellow color oval shape biconvexed film coated… | C10AA05 | atorvastatin | Innocia Lifesciences Private Ltd | 12, Balaji Nagar, Ambattur, Chennai - 53,… | ah@innocialife.com | ATOZ PHARMACEUTICALS PVT LTD | 18, NEW NO. 12, BALAJI NAGAR, AMBATTUR, CHENNAI… | Registered | Valid |
| 4 | PHILLIPS THERAPEUTICS LIMITED | 17317 | FEROPLUS Capsules | Human | Foreign | Ferrous Fumarate BP Equivalent to Elemental Iron… | Ferrous Fumarate (Equivalent to Elemental Iron 49… | H2019/CTD2133/683ER | Capsule | ORAL | Recommended | 24 months | Hard Gelatin Capsule. Orange cap/Clear… | B03AE10 | various combinations | Wockhardt Limited | Wockhardt Towers, Bandra - Kurla Complex, Bandra… | KBerde@wockhardt.com | Osaka Pharmaceuticals Limited | Old National Highway No. 8, Sankarda - 391 350,… | Registered | Valid |
| 5 | ORIANA LIMITED | 17399 | SEVLAREN 800 | Human | Foreign | Sevelamer Carbonate | Each Tablet contains Sevelamer Carbonate 800 mg | H2019/CTD6179/921ER | Tablet | ORAL | Recommended | 24 months | | V03AE02 | sevelamer | | | | STANFORD LABORATORIES PVT LTD | | Registered | Valid |
| 6 | PSM PHARMACEUTICALS LTD | 17434 | Temozol | Human | Foreign | Temozolomide | 100 mg/capsule | H2019/CTD7503/868ER | Capsule | ORAL | Recommended | 24 months | | L01AX03 | temozolomide | | | | Khandelwal Laboratories Pvt. Ltd - Thane | B-1, Wagle Industrial Estate, Thane – 400 604 | Registered | Valid |
| 7 | PSM PHARMACEUTICALS LTD | 17437 | PSM’S EPRAZ | Human | Foreign | Esomeprazole magnesium trihydrate | 40 mg | H2019/CTD7507/872ER | Tablet | ORAL | Recommended | 36 months | | A02BC05 | esomeprazole | | | | GLOBELA PHARMA PVT | 357, GIDC, ROAD 3, SACHIN, SURAT 394230, GUJARAT… | Registered | Valid |
| 8 | PHILLIPS THERAPEUTICS LIMITED | 17592 | INVEGA® 9 mg prolonged-release tablets | Human | Foreign | Paliperidone | Each prolonged-release tablet contains 9 mg of… | H2018/4832/173ER | Prolonged-Release Tablet | ORAL | Recommended | 24 months | | N05AX13 | paliperidone | | | | Janssen Ortho LLC & Janssen Cilag Manufacturing… | State Road 933 Km 0.1 Mamey Ward, Gurabo, Puerto… | Registered | Valid |
| 9 | DAWA LTD | 17655 | OLAM TABLET | Human | Local | OLMESARTAN MEDOXOMIL AND AMLODIPINE BESYLATE | OLMESARTAN MEDOXOMIL 20MG AND AMLODIPINE (AS… | H2019/CTD6956/892ER | Film-Coated Tablet | ORAL | Recommended | 24 months | | C01DX | Other vasodilators used in cardiac diseases | | | | DAWA LTD | PLOT NO. 7879/8, BABA DOGO RD, RUARAKA, NAIROBI | Registered | Valid |
| 10 | UMOJA PHARMACEUTICALS LTD | 17679 | KILMAX 500 | Human | Foreign | Amorphous Cefuroxime Axetil USP Eq. to Cefuroxime | 500 MG | H2019/4642/1054ER | Film-Coated Tablet | ORAL | Recommended | 36 months | | J01DC | Beta-lactamantibacterials: Second-generation… | | | | Eskayef Bangladesh Limited-Tongi Site | Gazipur, BD-1711 | Registered | Valid |