Compresso MF 95P by Granules India Limited Compresso MF 95P

Compresso MF 95P by

Drug Labeling and Warnings

Compresso MF 95P by is a Other medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COMPRESSO MF 95P- compresso mf 95p powder 
Granules India Limited

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Compresso MF 95P

COMPRESSO MF 95 P

(Directly compressible granules containing Metformin HCl USP/Ph.Eur. - 95%)

SPECIMEN LABEL

Batch No.:			Drum No.:
Mfg. Dt.:			Tare Wt.:
Exp. Dt.:			Net Wt.:
Mfg. Lic. No.:		37/RR/AP/2003/F/R	Gross Wt.:
Storage:		Preserve in well closed containers. Store between 15 – 30°C
Caution		For Manufacturing, Processing, or Repacking only.
GIL / PL / 036	Manufactured in India by:Granules India LimitedPlot No. 160/A, 161/E, Gagillapur VillageQutbullapur Mandal, Ranga Reddy Dt – 500 043, AP.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPRESSO MF 95P 
compresso mf 95p powder

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-711
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	95 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
POVIDONE K90 (UNII: RDH86HJV5Z)
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 68401960MK)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-711-00	5000000 mg in 1 BAG	10/24/2013
2	NDC: 62207-711-01	10000000 mg in 1 BAG	10/24/2013
3	NDC: 62207-711-02	25000000 mg in 1 BAG	10/24/2013
4	NDC: 62207-711-03	40000000 mg in 1 BAG	10/24/2013
5	NDC: 62207-711-04	50000000 mg in 1 BAG	10/24/2013
6	NDC: 62207-711-11	25000000 mg in 1 BAG	10/24/2013
7	NDC: 62207-711-12	40000000 mg in 1 BAG	10/24/2013
8	NDC: 62207-711-13	50000000 mg in 1 BAG	10/24/2013
9	NDC: 62207-711-14	60000000 mg in 1 BAG	10/24/2013
10	NDC: 62207-711-16	100000000 mg in 1 BAG	10/24/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		10/24/2013

COMPRESSO MF 95P 
compresso mf 95p powder

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-400

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	95 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
POVIDONE K90 (UNII: RDH86HJV5Z)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-400-12	40000000 mg in 1 DRUM	08/17/2017
2	NDC: 62207-400-13	50000000 mg in 1 DRUM	05/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/17/2017

Labeler - Granules India Limited (915000087)

Registrant - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(62207-711, 62207-400) , analysis(62207-711)

Revised: 5/2023

Document Id: fab67e5a-7e84-e29c-e053-6394a90aea37

53409-9

Set id: e2b5ab63-203d-4cd5-b719-4f2f4759a0d1

Version: 7

Effective Time: 20230502