We supply high-quality, reliable APIs to leading generic formulations manufacturers
Symbiotica supplies high-quality, reliable APIs to leading generic formulations manufacturers and is the preferred API partner to pharmaceutical companies worldwide. Symbiotica thrives on the deep technical strengths proven over the last two decades in developing and manufacturing complex APIs.
Our dedication to excellence has been recognised through numerous achievements. We are the first company in Asia to receive the CEP for Dexamethasone Sodium Phosphate and have successfully obtained US FDA and Japan PMDA certifications. With a diverse portfolio of 78 API products and over 15 new API products in development, we regularly supply our APIs to more than 80 countries and over 250 clients globally.
| Type | Product Name | Certifications | Enquire |
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| Steroids | Loteprednol Etabonate |
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Pharmacopoeia
Application
Status
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Non-pharmacopeoial / Inhouse specification
Human health products
Being developed
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| Steroids | Medroxyprogesterone Acetate |
CEP ‘26
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CEP ‘26
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Pharmacopoeia
Micronized Form
Sterile Form
Application
US DMF
DMF/ASMF/CTD
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EP, USP
Available
Terminal sterilization by Gamma on request
Human health products
To be filed on request
To be readied based on request
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| Steroids | Megestrol Acetate |
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Pharmacopoeia
Application
Status
|
EP, USP
Human health products
Being developed
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| Steroids | Mesterolone |
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Pharmacopoeia
Application
Status
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EP, USP
Human health products
Developed and being validated
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| Steroids | Methylprednisolone |
CEP ‘26
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CEP ‘26
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Pharmacopoeia
Micronized Form
Sterile Form
Application
US DMF
DMF/ASMF/CTD
|
EP, USP
Available
Terminal sterilization by Gamma on request
Human health products
To be filed on request
To be readied based on request
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| Steroids | Methylprednisolone Aceponate |
EU-ASMF
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EU-ASMF
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Pharmacopoeia
Micronized Form
Application
US DMF
CEP
|
Non-pharmacopeoial / Inhouse specification
Available
Human health products
To be filed on request
CEP to be applied once product monograph launched in EP
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| Steroids | Methylprednisolone Acetate |
ASMF
CTD
DMF
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ASMF
CTD
DMF
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Pharmacopoeia
Micronized Form
Sterile Form
Application
CEP
US DMF
|
EP, USP
Available
Terminal sterilization by Gamma on request
Human and animal health products
CEP to be applied on request
To be filed on request
|
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| Steroids | Methylprednisolone Hemisuccinate |
CEP ‘25
US DMF ‘25
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CEP ‘25
US DMF ‘25
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Pharmacopoeia
Micronized Form
Sterile Form
Application
|
EP, USP
Available
Terminal sterilization by Gamma on request
Human health products
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| Steroids | Methyltestosterone |
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Pharmacopoeia
Application
Status
|
EP, USP
Human health products
Developed and being validated
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| Steroids | Mometasone Furoate |
ASMF
CEP
CTD
DMF
US DMF
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ASMF
CEP
CTD
DMF
US DMF
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Pharmacopoeia
Micronized Form
Sterile Form
Application
US DMF
|
EP, JP, USP
Available
Terminal sterilization by Gamma on request
Human health products
Available, GDUFA fee paid, Ready for access
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Disclaimer
No information in this brochure - including any reference to any product or service - constitutes an offer for sale, or should be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. Buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent-related liabilities. Products protected under valid patents in Malaysia are not available for commercial use but may be available for research and regulatory purposes.