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FDA Licensed Chemicals manufacturing company for Sale near Mumbai, Maharashtra.

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FDA Licensed Chemicals manufacturing company for Sale near Mumbai, Maharashtra.

This is a running and profit making 48 year old company, spread over 3000 square meters of leased land in an Industrial area 45 kms of north-east of Mumbai. The constructed area is 25000 square feet of built-up area, which was constructed in 2005.

The Current Annual Turnover is in the range of INR 18-20 Crores and doing well.

The Promoters would like to exit the business as nobody from the Family is expected to be part of the Business as they are settled abroad.

It is licensed by Indian FDA to produce Bulk drugs and currently producing Pharma
grade solvents, ideal for Overseas buyers.

Manufacturing Capacity: (spread in 3 manufacturing halls)

  1. Distillation Capacity = 20000 Liters/day
  2. Permeation Capacity = 90000 Liters/day

List of products:
1.Isopropyl Alcohol – IP, BP, Ph Eur, USP
2.Acetone – IP, BP, Ph Eur, NF
3.Methanol – IP, BP, Ph Eur, NF
4.Dichloromethane – IP, BP, Ph Eur, NF
5.Dimethyl Sulfoxide – IP, BP, Ph Eur, USP
6.Acetonitrile – IP, BP
7.Chloroform – IP, BP
8.Formaldehyde – IP, BP, USP

All Manufacturing licenses in place.

MPCB consent

Factory license

GMP certification

FDA license

Poison license

Explosive godown license

ISO 9001 & 14001 certifications

Key points:

  1. All applicable licenses & certifications for Facility
  2. Instruments = Adequate and Ultramodern 21 CFR compliant with IQ, OQ & PQ
  3. Personnel = Competent and experienced manpower
  4. Documentation = Authentic records with identification and traceability at each
    stage with supporting raw data
  5. Validation = Method & Excel sheet validation records
  6. On time Calibration & Preventive Maintenance for smooth functioning
  7. Maintaining Stability & control samples
  8. Preparation of Annual product review
  9. Handling of Quality Notifications = Change control, Deviation, CAPA,OOS
  10. Performing Internal audits & Trainings as per predefined schedule
  11. Handling of Customer complaints and returned goods
  12. Handling of Legal and customer audits
  13. Documentation support = COA, MSDS, all relevant documents for export.

For more information, WhatsApp to us at Mobile No. 91- 98200 – 88394 or email to intellex@intellexconsulting. com

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Team Intellex Strategic Consulting Private Limited ( India)

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