Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.

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01 1Symbiotica Speciality Ingredients Sdn Bhd
02 1Cohance Lifesciences
03 1Tenatra Exports
04 1Macsen Labs
05 1Zeal Medipharma
06 1Alembic Pharmaceuticals Limited
07 1Aurore Life Sciences
08 1Bo-Chem
09 1Brawn Laboratories Ltd
10 1Freemen Nutra
11 1Guangzhou Tosun Pharmaceutical
12 1Hengdian Group
13 1Hermes Chemical
14 1Jubilant Biosys Ltd
15 1Jubilant Generics
16 1M2i Group
17 1Olon S.p.A
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01 3China
02 1France
03 11India
04 1Italy
05 1Malaysia
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01 1Active
02 16Blank
01 17Blank
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01 17Blank
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01 13923/25
02 1WC-0092
03 1WC-0542
04 14Blank
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01 120210317-209-J-889
02 120210323-211-J-613
03 15Blank
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01 152128-175
02 165372-1135
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Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
Date of Issue : 2025-05-20
Valid Till : 2028-05-22
Written Confirmation Number : 3923/25
Address of the Firm :
NDC Package Code : 52128-175
Start Marketing Date : 2013-10-08
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2021-03-23
Registration Number : 20210323-211-J-613
Manufacturer Name : Symbiotica Specialty Ingredients Sdn. Bhd@Hwail Pharmaceutical Co., Ltd.
Manufacturer Address : No. 518, Jalan Waja 4, Taman Industri Waja, 09000 Kulim, Kedah, Malaysia @ 45, Balangongdan-ro 1-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21990
Submission : 2008-09-26
Status : Active
Type : II

Date of Issue : 2025-02-14
Valid Till : 2027-11-04
Written Confirmation Number : WC-0092
Address of the Firm :
NDC Package Code : 65372-1135
Start Marketing Date : 2008-09-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT


Date of Issue : 2022-09-12
Valid Till : 2025-08-12
Written Confirmation Number : WC-0542
Address of the Firm :


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A Dicetel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dicetel, including repackagers and relabelers. The FDA regulates Dicetel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dicetel 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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A Dicetel supplier is an individual or a company that provides Dicetel active pharmaceutical ingredient (API) or Dicetel finished formulations upon request. The Dicetel suppliers may include Dicetel API manufacturers, exporters, distributors and traders.
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