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Essential Documents and Licenses for Third-Party Pharma Manufacturing in India

The Indian pharmaceutical industry is one of the largest in the world, and third-party manufacturing plays a crucial role in meeting the growing demand for high-quality medicines. Whether you are a startup or an established business, understanding the necessary documents and licenses is critical for compliance and smooth operations. This guide outlines the key requirements and highlights compliance-friendly cities for pharma manufacturing in India.

Key Documents and Licenses Required

1. Drug Manufacturing License (Form 28 & 28-B)

A manufacturing license is mandatory under the Drugs and Cosmetics Act, 1940. Form 28 is for loan licensing, while Form 28-B is for contract manufacturing.

2. GST Registration

Goods and Services Tax (GST) registration is compulsory for all pharmaceutical businesses involved in manufacturing and supply.

3. Wholesale Drug License (Form 20-B & 21-B)

Required for the storage and sale of drugs. Form 20-B is for proprietary medicines, while Form 21-B is for retail and wholesale distribution.

4. Trade License

Issued by the local municipal authority, this license allows businesses to operate legally within a specific region.

5. FSSAI Registration (If Applicable)

Necessary for companies involved in nutraceuticals or food-related pharma products.

6. Import-Export Code (IEC)

Required for businesses engaged in the export of pharmaceutical products.

7. Pollution Control Board (PCB) Clearance

Environmental clearance is mandatory to ensure compliance with waste disposal and pollution control norms.

8. Trademark Registration

Protects the brand name and prevents unauthorized use by competitors.

9. WHO-GMP Certification

World Health Organization-Good Manufacturing Practices (WHO-GMP) certification ensures adherence to international quality standards.

10. MSME Registration

Provides benefits such as subsidies and easier access to loans for small and medium-scale manufacturers.

Top Compliance-Friendly Cities for Pharma Manufacturing

India has several pharmaceutical hubs with robust infrastructure and regulatory support. Some of the most compliance-friendly cities include:

1. Baddi (Himachal Pradesh) – Known for tax benefits and a thriving pharma industry.
2. Chandigarh – A major hub for pharma franchise in Chandigarh and pharma third party manufacturing in CHD.
3. Mumbai (Maharashtra) – Home to leading pharmaceutical companies.
4. Hyderabad (Telangana) – A growing center for bulk drug manufacturing.
5. Ahmedabad (Gujarat) – Strong presence of PCD pharma franchise companies.
6. Bengaluru (Karnataka) – Hub for biotechnology and formulations.
7. Indore (Madhya Pradesh) – Emerging as a key manufacturing location.
8. Vadodara (Gujarat) – Known for its API and formulation units.
9. Pune (Maharashtra) – A major cluster for allopathic PCD pharma franchise businesses.
10. Dehradun (Uttarakhand) – Offers incentives for pharma setups.
11. Sikkim – Tax benefits attract pharma third party manufacturing in Baddi-based companies.
12. Goa – Emerging as a favorable destination for small-scale units.
13. Chennai (Tamil Nadu) – Strong regulatory compliance and infrastructure.
14. Vizag (Andhra Pradesh) – Growing API and formulation industry.
15. Noida (Uttar Pradesh) – Proximity to Delhi aids logistics.
16. Jaipur (Rajasthan) – Affordable operational costs.
17. Nagpur (Maharashtra) – Strategic location for distribution.

Why Choose Pharma Franchise & Third-Party Manufacturing?

Opting for a pharma franchise in Chandigarh or pharma PCD companies in Baddi can be a profitable business model with low investment and high returns. Established companies provide marketing support, regulatory assistance, and a wide product range, making it easier for entrepreneurs to enter the market.

For those looking for reliable partners, selecting the best pharma company in Chandigarh or top PCD pharma company in Chandigarh ensures quality and compliance. Similarly, pharma third party manufacturing in Baddi offers cost-effective production with regulatory approvals in place.

Final Thoughts

Navigating the regulatory landscape of third-party pharma manufacturing requires meticulous documentation and adherence to compliance norms. By securing the necessary licenses and partnering with established players in key cities like Chandigarh, Baddi, and Hyderabad, businesses can ensure sustainable growth trajectory in India’s booming pharmaceutical sector.

Created on : 2025-10-23 07:20:12

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