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Loan License, Third Party Manufacturer or Contract Manufacturer : Best option for Pharmaceutical Start-ups

Query:  Please help me in this regard. 1. We want to market following these products. Protein Powder Multivitamin Capsules Amoxicillin + Potassium Clavulanate Tablets Cefixime Tablets Chlorzoxazone + Aceclofenac + Paracetamol Tablets 2. We want to Market under our Company Logo. 3. Which is the best option for us. Loan License. Third Party Manufacturer. OR Contract Manufacturer. We need different company names located only in Hyderabad to manufacture above said products. Response: Third Party Manufacturer  will be a better way for you to start with as it requires less effort to get manufactured own brand name product under own logo at initial stage... Later when you will be established, going into loan licensing or contract manufacturing will be good. Sorry for different company names as we don't recommend companies. Check out List of Pharmaceutical Companies in Telangana

How to start nutritional products manufacturing in India?

Question: I am Currently Australian and Indian dual country registered Pharmacist. I am also certified in anti-ageing practitioner and I work with specialists to develop custom made nutritional and topical preparations.
I would like start nutritional products manufacturing in India with initial third-party manufacturing and contract manufacturing. My question is, if there is a reference to check classification of the nutrients that I want to put in to the formulations to know
1. Needs prescription
2. Needs clinical studies
3. Needs stability and comparability data
4. Any certifications/formulation approval needed or a formulation pharmacist is needed
5. Restrictions on supply through publishing on website



Answer:

For starting nutritional products manufacturing units in India, you need to take FSSAI central license. Check out: Procedure and documents for starting nutraceutical manufacturing unit

All nutritional products are fall under Food Act and regulated in India by FSSAI (Food Safety and Standards Authority of India).

1. Nutritional products don’t require prescription to sell

2. No clinical trial is needed for already approve nutritional ingredients but if any ingredient which safety is not proven then you require to take prior approval from FSSAI before manufacturing or importing it in India. You can use nutritional ingredient in your product on the basis of limit or RDA (Recommended Dietary Allowance) by FSSAI.

3. No comparability or stability data required till now

4. Formulation approval may require from FSSAI before starting manufacturing of any formulation but a formulation pharmacist is not required.

5. There is no restriction to supply through publishing on website as these are not fall under prescription drugs.

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