Manufacturing facility
An organization’s capabilities and intent are strongly reflected in the product it manufactures. The manufacturing competencies and facilities must echo truly in the quality that is offered to the customers. This can be achieved only by having a world class manufacturing facility
Manufacturing facility
An organization’s capabilities and intent are strongly reflected in the product it manufactures. The manufacturing competencies and facilities must echo truly in the quality that is offered to the customers. This can be achieved only by having a world class manufacturing facility
- UNFPA Pre Qualified Manufacturing Facility
- c GMP Compliant Plant
- State-of-the-art Fully Automatic Condom Manufacturing Machines
- Well proven and time-tested German Technology
- Dry and relatively more efficient Electronic Testing Machines
- Electronically Controlled Primary Packaging Machines
- Well trained, industry-best human capital
- Food Grade Ingredients
- Installed Capacity: Over 350 Million Pieces per annum
- UNFPA Pre Qualified Manufacturing Facility
- c GMP Compliant Plant
- State-of-the-art Fully Automatic Condom Manufacturing Machines
- Well proven and time-tested German Technology
- Dry and relatively more efficient Electronic Testing Machines
- Electronically Controlled Primary Packaging Machines
- Well trained, industry-best human capital
- Food Grade Ingredients
- Installed Capacity: Over 350 Million Pieces per annum
The Process
The Quality Credentials
At MHL we believe quality is a state of mind! In its quest for excellence, the company has invested in strong quality systems and comprehensive personnel training programs.
Certificates and Approvals:
- UNFPA Pre Qualified Supplier Status
- ISO 9001-2008: Certified by DNV
- ISO 13485-2003: Certified by DNV
- CE Mark (Annex II) 93/42EEC Medical Devices Directive: Awarded by DNV
- 510k Approval: Issued by US FDA Washington USA
- GMP Certificate: from Directorate General od Medical & Health Services; (Indian FDA)
- Drug Manufacturing License: from Indian FDA
- ISO 14001:2005
- OHSAS 18001:2007
- UNFPA Pre Qualified Supplier Status
- ISO 9001-2008: Certified by DNV
- ISO 13485-2003: Certified by DNV
- CE Mark (Annex II) 93/42EEC Medical Devices Directive: Awarded by DNV
- 510k Approval: Issued by US FDA Washington USA
- GMP Certificate: from Directorate General od Medical & Health Services; (Indian FDA)
- Drug Manufacturing License: from Indian FDA
- ISO 14001:2005
- OHSAS 18001:2007
The Regulatory Certifications:
International Market Reach
| Sr.No | Registration or Certfication Type | Certifying Agency | Countries where Applicable |
|---|---|---|---|
| 1. | Certificates of Free Sale | Indian Food Safety and Drug Administration | All Countries |
| 2. | INMETRO Approval and ANVISA Number | Brazilian Drug Authorities and Ministry of Health | For Saless in Brazil |
| 3. | ANVISA Number Registration | Ministry of Health: Government of Argentina | For Sales in Argentina |
| 4. | Product Registration | Ministry of health: Govt of Uzbekistan | For Sales in Uzbekistan |
| 5. | Product Registration | Ministry of health: Govt of Nigeria | For Sales in Nigeria |
| 6. | Product Registration | Ministry of health: Govt of Indonesia | For Sales in Indonesia |
| 7. | Product Registration | Ministry of health: Government of Sri Lanka | For Sales in Sri Lanka |
| 8. | Product Registration | Ministry of health: Government of Nepal | For Sales in Nepal |
| 9. | SABS Permit | South African Bureau of Standard (SABS), Republic of South Africa | For Sales in South Africa |