China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress

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01 1Shandong Chenghui Shuangda Pharmaceutical
02 1Ami Lifesciences Private Limited
03 1Mankind Pharma
04 1Shandong Loncom Pharmaceutical
05 1Lewens Labs
06 1Biophore India Pharmaceuticals Pvt Ltd
07 1Evonik
08 1Metrochem API Private Limited
09 1Dr. Reddy's Laboratories
10 1Egis Pharmaceuticals PLC
11 1Zhejiang Hengkang Pharmaceutical
12 1HRV Pharma
13 1Neuland Laboratories
14 1Tagoor Laboratories
15 1Maithri Drugs
16 1Anlon Healthcare Ltd
17 1Enaltec Labs
18 1Alborz Pharmed
19 1Anvitha Lifecare
20 1Apino Pharma
21 1Beijing Mesochem Technology
22 1Beijing Sjar Technology Development
23 2Catalent Pharma Solutions
24 1Changzhou Pharmaceutical Factory
25 1Cipla
26 1Curia
27 1Hangzhou APIChem Technology
28 1Livmore Life Sciences
29 1Micro Labs Limited
30 1Parsian Pharamceutical
31 1Precise Group
32 1Raghava Life Sciences
33 1Royal Pharma
34 1Sichuan Elixir Pharmaceuticals
35 1Tianjin Hankang Pharmaceutical Biotechnology
36 1Viyash Life Sciences
37 1Zhejiang Hisun Pharmaceutical
38 1Zydus Lifesciences
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01 11China
02 1Germany
03 1Hungary
04 21India
05 2Iran
06 3U.S.A
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01 7Active
02 32Blank
01 39Blank
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01 39Blank
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01 1SD250051
02 38Blank
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01 39Blank
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01 162128-0396
02 165392-3203
03 169988-0061
04 169988-0062
05 181666-009
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China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
Date of Issue : 2025-04-07
Valid Till : 2028-05-08
Written Confirmation Number : SD250051
Address of the Firm :
Lewens Labs transforms healthcare with innovative, sustainable, and affordable pharmaceutical solutions worldwide.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42713
Submission : 2025-09-30
Status : Active
Type : II
NDC Package Code : 62128-0396
Start Marketing Date : 2024-03-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42172
Submission : 2025-08-08
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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We have 38 companies offering Resmetirom (MGL-3196)
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