ABOUT US

 

 
  1. General Information :

1.1 Brief Information of the Firm :
ADORE PHARMACEUTICAL PVT. LTD. (Adore) is engaged in Pharmaceutical formulations manufacturing activities since 1987. The Sterile Processes Area was initially set up by M/s. Klainzaids.

  • Adore factory has total Built up Area of about 10698 sq. ft. we carryout manufacturing activities of liquid vials, liquid ampoules and sterile powder injectables in the respective sections.


  • General G.M.P. certificate dated 06-07-1998 was issued to us by Food and Drug Administration, Thane, Maharashtra state.


  • M/s. Glaxo India Limited, was the first loan-licensing party and we had been manufacturing Ceporan Injection (Cephaloridine) and Supacef Injections (Cefuroxime sodium Inj.) for Glaxo India Ltd.


  • Also, in past, we have manufactured Polybion Injection 2 ml (inj. of Vitamin B Complex) for M/s E-Merck, Trigan Injection (Analgin Injection) for M/s Cadila Laboratories Ltd., Pirox Injection (Piroxicam Injection), Emeset Injection (Ondensetron Injection), Ciplox Eye / Ear Drops (Ciprofloxacin Hydrochloride Eye / Ear Drops), Norflox Eye / Ear Drops (Norfloxacin Eye / Ear Drops), Moxiclox Injection (Amoxycillin and Cloxacillin Injection) for M/s. Cipla Ltd. and Novaclox Injection (Amoxycillin and Cloxacillin Injection) for M/s. Okasa Ltd.

Currently we are manufacturing on loan License basis for :

Name of Company Mfg. Lic. No.
1. M/s. Promed Exports Pvt. Ltd. KD-937A

2. M/s. Shreya Life Sciences Pvt. Ltd.; Mumbai KD-1462A

3. M/s. Lyka Hetero Healthcare Ltd. KD-1698A

4. M/s. Coral Laboratories Ltd., KD-802A

5. M/s. Care Unipac Pvt. Ltd. KD-1041A

6. M/s. DeVats (India) Pvt. Ltd. KD-1487A

7. M/s. Garland Pharma Pvt. Ltd. KD-1564A

8. M/s. Leben Laboratories Pvt. Ltd. KD-1616A

9. M/s. SG Pharma Pvt. Ltd. KD-1770A

10. M/s. Troge Medical Pvt. Ltd. KD-1614A



On Third Party Basis --- We are manufacturing for:

1. M/s DWD Pharmaceuticals Ltd. : D-Cef, Dofec  
       
2. M/s Entod Pharmaceuticals Ltd. : Catagon eye drops  
       
3. M/s Hindustan Antibiotics Ltd. : Gentamicin Injection IP  

1.2 A detailed list of products of various parties are annexed to this file.

1.3 Any Other Manufacturing Activities Carried Out On The Site.

Apart from the formulation manufacturing activities, as indicated earlier, there is no other
type of manufacturing activities, carried out at our site.

1.4 Name And Exact Address Of The Site Including Telephone, Fax And 24 Hrs. Telephone
Numbers.

Name And Address Of The Site :

ADORE PHARMACEUTICAL PVT. LTD.
5/6 Khokhani Industrial Complex No. 2,
Kaman Road, Sativali, Vasai (East),
Dist. : Thane – 401 208.
   
       
Telephone No. / Fax : 95250 – 2481403.
95250 – 2481404.
   
       
24 Hrs. Contact Telephone No. : As above.    

1.5 Types of products manufactured on the site and information about any specifically toxic or hazardous substances handled.

The Company Manufactures Pharmaceutical Formulations only, in Small volume Liquid and Sterile Powder injection form

Toxic Or Hazardous Preparations Manufactured : None  
     
Toxic Or Hazardous Chemicals Handled : None  

1.6 Short description of the Sit

Area : Total Area of the site is 3484 sq. meters  
     
Exact Location : The Factory is located in Sativali Village At Vasai, Approx. 60 K.M. North of Mumbai.  
     
Immediate Environment : Engineering Units and Residential area.  


1.7 Number of employees engaged :

 

Department

No. of Employees  
       
 
  • Production
40 Nos.  
       
 
  • Quality Control
7 Nos  
       
 
  • Stores
4 Nos.  


1.8 Use of outside scientific, analytical assistance or other technical assistance in relation to manufacturing or analysis :

Use of scientific assistance for manufacturing :
Not Applicable  
     
Use of analytical assistance taken : Samples are sent to the following
F.D.A. Approved Testing Laboratories,
on need basis.
 

1) M/s. Invochem Laboratories, Vasai. – Thane.
2) M/s. Bee Pharmo Laboratories Pvt. Ltd, Worli, Mumbai – 18.
3) M/s Manisha Analytical Laboratories Pvt. Ltd, Kandivali, Mumbai – 67.

1.9 Short description of the Quality Management system of the company :

Adore Management has endorsed the Quality Policy and demonstrated its commitment to adhere to cGMP and deliver Quality products through continuous Improvements in the systems, procedure and processes. For effective implementation of Quality Systems various quality system procedures are followed which include.

  • Validation Of Equipment And Processes Protocols And Procedures
  • Calibration Protocols And Procedures.
  • OOS and Deviation control
  • Quality Control Procedures.
  • Master Formula Records.
  • Product Manufacturing Procedures.
  • Product Testing Procedures.
  • Raw Materials And Finished Product Specifications
  • Standard Operating Procedures For Equipment Operations, Instrument Operations And Process Operations.
  • Laid Down Documentation Systems.
  • In process Quality Control Checks.
  • Batch Manufacturing Records Review And Batch Release System.