Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
01 1Olpha
02 1Cilag AG
03 1Freemen Nutra
04 1Northeast Pharmaceutical Group Co Ltd
05 1TBD Pharmatech
06 1Blank
01 2China
02 1Estonia
03 1Latvia
04 1Switzerland
05 1Blank
01 1Active
02 2Inactive
03 3Blank
01 6Blank
01 6Blank
01 6Blank
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-17
Pay. Date : 2012-11-27
DMF Number : 15210
Submission : 2000-12-21
Status : Active
Type : II
NDC Package Code : 63818-0434
Start Marketing Date : 2016-05-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
| Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10233
Submission : 1993-05-05
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14936
Submission : 2000-06-22
Status : Inactive
Type : II
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A Rimantadine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rimantadine Hydrochloride, including repackagers and relabelers. The FDA regulates Rimantadine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rimantadine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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