European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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01 2Polpharma
02 1Sanofi
03 1LGM Pharma
04 1Dr. Reddy's Laboratories
05 1Jai Radhe Sales
06 1HRV Pharma
07 1Octavius Pharma Pvt. Ltd
08 1Tenatra Exports
09 1Apex Healthcare Limited
10 1Swati Spentose
11 1Alembic Pharmaceuticals Limited
12 1Anek Prayog Pvt. Ltd.,
13 1Apotex Inc
14 1Assia Chemical Industries Ltd
15 2Aurobindo Pharma Limited
16 1CSPC Pharmaceutical Group
17 1CTX Lifesciences
18 2Cadila Pharmaceuticals
19 2Chemi SpA
20 1Chongqing Carelife Pharmaceutical
21 2Cipla
22 1DEAFARMA
23 1Divis Laboratories
24 1Gador SA
25 1Gedeon Richter
26 1Globalchem
27 1Guangzhou Tosun Pharmaceutical
28 2Ipca Laboratories
29 1JPN Pharma
30 1Jubilant Biosys Ltd
31 1Jubilant Generics
32 1Lupin Ltd
33 1Matrix Pharmaceutical Inc
34 1Medichem S.A
35 1Minsheng Group Shaoxing Pharmaceutical
36 1Orchid Pharma
37 1RR LIFESCIENCES
38 1Ryoto Fine Co
39 1SRK Bio Pharma
40 1Samhwa Biopharm
41 1Shaanxi Hanjiang pharmaceutical Group Co
42 1Signa S.A. de C.V.
43 2Sun Pharmaceutical Industries Limited
44 1Teva Pharmaceutical Industries
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01 1Argentina
02 1Canada
03 5China
04 3France
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06 29India
07 2Israel
08 4Italy
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11 2Poland
12 1South Korea
13 1Spain
14 3U.S.A
15 1Blank
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01 12Active
02 11Inactive
03 33Blank
01 10Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 2Withdrawn by Holder
04 43Blank
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01 1219MF10310
02 1220MF10178
03 1220MF10241
04 1227MF10301
05 1228MF10049
06 1229MF10112
07 50Blank
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01 1WC-0023
02 1WC-0030
03 2WC-0074
04 1WC-0089
05 1WC-0091
06 2WC-0144
07 2WC-0168
08 1WC-0236
09 1WC-0409
10 44Blank
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01 120210323-209-J-897
02 120210323-209-J-897(1)
03 120210331-209-J-915
04 120250715-209-J-1952
05 52Blank
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01 112658-0489
02 112658-0568
03 113371-111
04 153104-7525
05 155111-874
06 157451-1157
07 162756-112
08 163415-0071
09 165372-1134
10 165691-0056
11 165862-268
12 45Blank
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European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-16
Pay. Date : 2014-11-28
DMF Number : 16962
Submission : 2003-11-17
Status : Active
Type : II
Certificate Number : R1-CEP 2003-273 - Rev 04
Issue Date : 2021-05-12
Type : Chemical
Substance Number : 1564
Status : Valid
Registration Number : 220MF10241
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2008-12-04
Latest Date of Registration :
NDC Package Code : 12658-0489
Start Marketing Date : 1999-11-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF, CN, CA |
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R1-CEP 2004-215 - Rev 04
Issue Date : 2019-01-04
Type : Chemical
Substance Number : 1564
Status : Valid
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
✕ Product Not Available For Sales
NDC Package Code : 55111-874
Start Marketing Date : 2006-12-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
Date of Issue : 2024-03-01
Valid Till : 2026-12-31
Written Confirmation Number : WC-0409
Address of the Firm :
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
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PharmaCompass offers a list of Alendronate Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Alendronate Sodium manufacturer or Alendronate Sodium supplier for your needs.
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A Fosamax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosamax, including repackagers and relabelers. The FDA regulates Fosamax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosamax API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Fosamax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Fosamax supplier is an individual or a company that provides Fosamax active pharmaceutical ingredient (API) or Fosamax finished formulations upon request. The Fosamax suppliers may include Fosamax API manufacturers, exporters, distributors and traders.
click here to find a list of Fosamax suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
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