Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
01 2Olpha
02 1Transo-Pharm USA LLC
03 1LGM Pharma
04 1Suanfarma
05 1Cohance Lifesciences
06 1Dr. Reddy's Laboratories
07 1Jai Radhe Sales
08 1HRV Global Life Sciences
09 1Alembic Pharmaceuticals Limited
10 1Amsa Spa
11 1Apotex Pharmachem
12 1Aspire Lifesciences Pvt Ltd
13 2CHEMO
14 1Cheer Fine Pharmaceutical
15 1DNP Fine Chemicals
16 1Darou Pakhsh Pharma Chem
17 1Emcure Pharmaceuticals
18 1Esteve Quimica
19 1Freemen Nutra
20 1Guangzhou Topwork Chemical
21 1Guangzhou Tosun Pharmaceutical
22 2Hainan Poly Pharm
23 1Hangzhou Longshine Bio-Tech
24 1Hermes Chemical
25 1Hetero Drugs
26 1Hikal
27 1Industriale Chimica
28 1JPN Pharma
29 1Lantech Pharmaceuticals
30 1Lupin Ltd
31 1MSN Laboratories
32 2Macleods Pharmaceuticals Limited
33 2Megafine Pharma (P) Limited
34 1Mulei (Wuhan) New Material Technology
35 1Murli Krishna Pharma
36 1Nishchem International Pvt. Ltd
37 1Northeast Pharmaceutical Group Co Ltd
38 1Nosch Labs Pvt
39 1Olon S.p.A
40 1Orchid Pharma
41 1Pellets Pharma Limited
42 1Procos
43 1RANBAXY LABORATORIES LIMITED
44 1Sharon Bio-Medicine Limited
45 1Smilax Laboratories Limited
46 1Sun Pharmaceutical Industries Limited
47 1Tai Heng Industry Co., Ltd
48 1Teva API
49 1Teva Pharmaceutical Industries
50 3UBE Industries
51 1UQUIFA
52 1Unichem Laboratories Limited
53 1Viatris
54 1Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd
55 1Zhejiang Supor Pharmaceuticals Co., LTD
56 2Zydus Lifesciences
57 1Blank
01 1Canada
02 12China
03 30India
04 1Iran
05 2Israel
06 4Italy
07 4Japan
08 2Latvia
09 5Spain
10 3U.S.A
11 1Blank
01 28Active
02 6Inactive
03 31Blank
01 65Blank
01 1229MF10004
02 1230MF10010
03 1230MF10048
04 1230MF10163
05 1231MF10005
06 1231MF10006
07 1231MF10007
08 1231MF10017
09 1231MF10021
10 1231MF10031
11 1231MF10038
12 54Blank
01 1WC-0015
02 1WC-0022
03 1WC-0062
04 1WC-0066
05 1WC-0081
06 1WC-0087-(Annexure-1)
07 1WC-0094
08 1WC-0153
09 1WC-0159
10 1WC-0195
11 1WC-0201
12 1WC-0226
13 1WC-0384
14 1WC-0460
15 1WC-0462
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Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-07
Pay. Date : 2012-11-27
DMF Number : 20543
Submission : 2007-05-09
Status : Active
Type : II
Registration Number : 230MF10048
Registrant's Address : 5 Rupnicu Street, Olain, LV-2114, Latvia
Initial Date of Registration : 2018-03-30
Latest Date of Registration : --
NDC Package Code : 63818-0004
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
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2020-05-22
Registration Number : 20200522-209-J-377
Manufacturer Name : JSC OlainFarm
Manufacturer Address : 5, Rupnicu Street, Olaine, LV-2114, Latvia
Available Reg Filing : ASMF |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-22
Pay. Date : 2019-02-11
DMF Number : 29180
Submission : 2015-03-16
Status : Active
Type : II
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0195
Address of the Firm :
NDC Package Code : 76072-1004
Start Marketing Date : 2016-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2022-01-13
Registration Number : 20200304-209-J-395(3)
Manufacturer Name : ZCL Chemicals Limited
Manufacturer Address : 3102/B GIDC, Industrial Estate Ankleshwar-393 002, Dist. Bharuch, Gujarat State India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-11-13
Pay. Date : 2015-11-05
DMF Number : 20841
Submission : 2007-09-07
Status : Active
Type : II
NDC Package Code : 55111-860
Start Marketing Date : 2010-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Registration Number : 230MF10010
Registrant's Address : 5 Rupnicu Street, Olain, LV-2114, Latvia
Initial Date of Registration : 2018-01-24
Latest Date of Registration : --
NDC Package Code : 63818-0004
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
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2020-05-22
Registration Number : 20200522-209-J-377
Manufacturer Name : JSC OlainFarm
Manufacturer Address : 5, Rupnicu Street, Olaine, LV-2114, Latvia
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18436
Submission : 2005-06-17
Status : Inactive
Type : II
NDC Package Code : 49711-1515
Start Marketing Date : 2010-07-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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