madhya pradesh public health services corporation limited ... · report (certificate of analysis)...

Madhya Pradesh Public Health Services Corporation Limited

Tender Ref. No. 184/MPPHSCL/Pharma/RC/2018, Dt. 15-05-18

Amendment No. 02, NIT 184 Prebid Queries and Resolution

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Queries Raised by Bidder Amendment/

Resolution

1 - - - -

Tender Condition - Refer to clause no. 13 under the

heading supply conditions and delivery period - all the

pharmaceuticals supplied under this contract will have

remaining a minimum of five-sixths (5/6) of the

specified shelf life

Amendment Requested - Since the purchase &

pattern is decentralized

and the orders are in small quantities for which we

have to keep inventory so we not be in a position to

offer you 83% shelf life and we request you to kindly

amend the shelf life period to 70%

No Change

2 - - - -

Tender Condition - Refer to clause no. 14 under the

heading logograms as specified in Annexure-I

Amendment Requested - Since the cost of change

part for affixing logogram as specified in the tender

will be around 7-8 lacs per product, therefore it is not

feasible for us to supply you the product with

logograms as specified in the tender irrespective of

the quantity & also we cannot give any declaration for

logograms as per Annexure I. We kindly request that

the logogram clause be relaxed so that we can

participate in the tender.

No Change

3 - - - -

Tender Condition - Refer to clause no. 18, 19 under

the heading liquidated damages and other penalties -

If there is any unexecuted order after 60" day from the

date of approved purchase order, on 61” day

unexecuted order will attract penalty @ 20%

Amendment Requested - Since the purchase pattern

is decentralized and

in many cases direct transportation may not be

available to all the required destinations.Therefore, in

such cases there may be delay in supplies and so

keeping in view of this, request is made to amend the

Penalty from 20% to 10%

No Change

4 - - - -

To accept short expiry products against undertaking

letter. No Change

5 - - - -

2. Order schedule 1 to 15 every month for better

supply and timely arrange good’s. No Change

6 - - - -

3. Non-supply & LD penalty @ 20% to 10% All

major state govt. central govt and PSU’s charge the

same. No Change




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7 - - - -

4. Penalty deducted before confirmation of District

Hospital and Medical College in some case district

hospital deducted non-supply penalty in our bills and

same is cooperation so total penalty is @40% in same

order.

No change in tender

terms, specific case

will be resolved

based on bidders

request basis.

8 - - - -

5. Unaccounted payment detail for old supplies from

district hospital.

No change in tender

terms, specific case

will be resolved

based on bidders

request basis.

9 - - - -

General-:

1. As decentralized purchase required to allow goods

for lesser self-life with under-taking. No Change

10 - - - -

Since, logistic expenses are increasing day by day as

such we request to ensure your minimum purchase

order value should be mimimum Rs. 10,000. No Change

11 - - - -

We will put barcode on products for single purchase

quantityequivanlent to our batch size otherwise if

quantity is small we will put barcode stickers. No Change

12 - - - -

1) Clause 10.2 Page No. 12 - Other Conditions

Sir, the quantity mentioned in Annexure 5 in tender

document should have a maximum selling of (+/-)

25% and if the quantity exceeds more than 25% than

the delivery period may also be increased accordingly.

Sir, the production capacity has been marked based on

the quantity mentioned in the tender and is being

utilized for other Government & Trade requirements.

Therefore, accommodation of increase in quantity will

disturb manufacturing capacity and require extra

delivery period.

No Change

13 - - - -

2) Clause 12.6 & 12.8 - Security Deposit &

Agreement

additional Security Deposit should always be

considered based on total security furnished for the

entire product allotted to the supplier. Therefore this

clause

should be amended as under —

Supply of excess quantity of particular product subject

to prior confirmation of supplier & if the Performance

Bank Guarantee cumulatively submitted against the

contract is within the limit of total contract value than

no additional Performance Bank Guarantee is

applicable because in few products the procurement

quantity may be less than actual quantity in tender.

No Change

14 - - - -

3) Clause 17.3 - Payment Provisioni) Sir, it has been

observed that the payment are not made timely and

are pending since 2 years inspite of regular follow up.

Therefore we request you to kindly amend Clause

No Change




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17.3 stating that if the payment is not made within 60

days from the date of receipt of Invoice, satisfactory

quality assurance report and all other relevant

documents than corporation will pay Interest @ 18%

on the delayed payment because in case of late

supplies corporation is deducting an LD of 0.5% per

day for 15 days and imposing non execution fine of

20% after making supplies in 75 days.ii) Sir, after

imposition of GST no deduction is permitted on

account of tax as per government norms. Therefore no

amount on account of GST should be deducted from

supplier’s bill.Sir, we sincerely request you to kindly

amend clause 17.3 suitably allowing payment of

Interest by corporation in cases where payment is

delayed for more than 60 days.

15 - - - -

4) Clause 18.2 - LD

Sir, the penalty for unexecuted order after 76th day

should only be 10% and not 20%. Such a heavy

penalty because of delay of more than 15 days may

discourage the supplier not to execute the order & will

affect the availability of medicine at hospital stores.

We therefore sincerely request you to kindly reduce

unexecuted imposition of penalty as 10% only.

No Change

16 - - - -

5) Clause 6, Page No 65 - Procedure of Blacklisting

Sir, the last line “If the sample has been tested by the

Govt. Lab at any stage, its report will be conclusive

and final”, should be deleted. Instead of this,

following lines should be inserted “If the sample fails

by Govt. Lab (Maybe because of faulty or unfit

container) than in such case second sample should be

drawn in presence of supplier’s representative of

useful bottles and should be sent for testing to

State/Central Laboratory and this second report

should be conclusive & till than no NSQ action should

be taken”.

Sir, in case of Ives drugs (India) Pvt Ltd a defective

bottle of sample which was unfit for use as per I.P

Monograph and instruction mentioned on label was

sent for testing and test report issued by CDL,

Calcutta has mentioned clearly that the product

contains particulate matter in the description itself,

whereas product has complied all other tests. Based

on this single report corporation has declared product

NSQ and has taken action which is unjustified.

Therefore to avoid such unjustified action even if the

product failed by Govt. Lab a second set of sample

should be drawn of same batch and should be sent for

testing and the second report may be considered as

conclusive and final report.

We would therefore request you to kindly amend

clause 6, page 65 suitably.

No Change




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17 - - - -

6) Clause 11 (a), Page No 66

Sir, supplier should be given a chance for personal

hearing with expert committee to explain the case

suitably and no NSQ should be declared without

personal hearing with the supplier.

No Change

18 - - - -

7) Annexure 10 - Serial No. 4

Sir, kindly add 60 days for injectables towards LD

deduction from the date of order. No Change

19 - - - -

Acceptance of short expiry products along with

undertaking letter. No Change

20 - - - - Anti Cancer products Quantity revision required as

per purchase data of last year. No Change

21 - - - -

In your current tender you have imposed penalty/LD

20% of invoice value while this percentage value does

not prevailed in any government insititutions across

India and this affects the cost of products as such you

may get higher rates than other states medical

corporations.

No Change

22 - - - -

Shelf life of product particularly Anti Cancer Drug

must be 60% since stability test and COA/NABL

report takes minimum 45 days to issue QC certificate. No Change

23 - - - -



order value should be minimum Rs. 10,000. No Change

24 - - - -

Whatever we supply against your purchase order is

without barcode system as none of your direct

demanding authorities has facility at present. No Change

25 - - - -

With reference to tender no -184

/MPPHSCL/Pharma/RC/2018, Dt. 15-05-18, wherein

tender document point no 13. 5 is mentioned as

below,13.5 The Bidder must submit a Test Analysis

report (Certificate of Analysis) from

GoMP's/MPPHSCL empanelled lab/ Gol's lab/ third

party NABL accredited laboratory (which is not

owned by manufacturer or having similar partner(s))

for every batch of drug along with invoice. In case of

failure on part of the supplier to furnish such report,

the batch of drugs will be returned back to the

suppliers and the bidder is bound to replenish the

same with Government approved lab test report.We

would like to bring to your kind notice that there are

two labs in India who has NABL accreditation for

testing Plasma Proteins & r-DNA products. One is

National Institute of Biologicals (NIB) and second is

Central Lab, Reliance Life Sciences. It takes

No Change




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approximately 90 to 120 days to get the test results

from NIB. Waiting for NIB test result will end up in

product having shorter shelf life. As per MPPHCL

tender clause the product should have a minimum of

80% shelf life at the time of supplies.In case of

MPPHCL, purchase orders are issued from different

locations and in small quantities. Furthermore

purchase orders are issued between long intervals

during RC period. In such scenario holding single

batch material to cater the supplies and abiding shelf

life clause of the tender is difficult and testing

multiple batch at third Party NABL lab is practically

not possible.As mentioned earlier, RLS central lab is

independently audited and accredited by NABL. We

hereby request you to kindly accept out in-house

NABL test report along with every supplies.Kindly

consider our request and issue an amendment

accordingly.

26 - - - -

In your current tender you have imposed penalty/LD

20% of invoice value while this percentage value does

not prevailed in any government institutions across

India and this affects the cost of products as such you

may get higher rates than other states medical

corporations.

No Change

27 - - - -

Shelf life of product particularly vaccine and

immunology products must be 60% since stability test

and COA/Kasuli/NABL report takes minimum 45

days to issue QC certificate.

No Change

28 - - - -



order value should be minimum Rs. 10,000. No Change

29 - - - -

Whatever we supply against your purchase order is

without barcode system as none of your direct

demanding authorities has facility at present. No Change

30 - - - -

In NIT-184 you have only ask for Inj. Insulin Glargin

vial, however we had Insulin Glargin 3ml catridge and

Disposable pen in rate contract which was valid up to

26-04-2018 and the requirement of product was

substantial from last 3 years that is 2016, 2017 and

2018 & both the products are very much friendly. We

request you to kindly include both the items in tender.

No Change




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31 120852

Etanercept

Injection

50mg/ml

1ml 78

For competition in the tender and competitive rate for

item specification allow to quote-:ETANERCEPT

25MG/vial

Both strengths

allowed to quote and

If bidder has quoted

25mg/vial then

bidder has to quote

rate for 2 vial that is

50mg Injection and

as per above if found

L1 and if rate

approved then rate

shall be halved to

arrive for 25mg

strength price and

NOA shall be issued

accordingly. Quantity

amended as 250.

32 120849

Micronized

progesterone Tab

200mg

10x10 7500

Item specification allow to quote-: PROGESTERONE

200MG (NATURAL MICRONIZED) SR Tablet Acceptable

33 120833 Afatinib Tablet

40mg 10x10 3000

1. Please correct the SKU / Packing as (4X7 Tablets).

2. Also confirm if we need to quote as per

SKU/packing provided in Tender i.e. 10X10 or as per

our packing i.e 4X7, once above mentioned

amendment no 1 is completed from your end . or we

have to quote per Tablet Rate

Refer Clause no.

10.15

34 120826 Lenalidomide

25mg Cap

30 per

bottle 105

Item SKU allow to quote-: 10X10 10x10 strip or any

other pack size is also

acceptable however

bidder has to quote

rate for 30Capsules

only and accordingly

NOA will be issued

as per quoted pack

size after conversion

of rate. Refer Clause

no. 10.15

35 120784 Tiotropium

9mcg Rotacaps

30cap.p

ack with

rothelar

465

1. Item Specification need to changed-:

TIOTROPIUM 18 mcg Rotacaps & SKU-: 15cap.x

12 pack with 1 rotahaler.

2. In pack size you have mention Rotahaler, which is

the device name of one company only. Instead of

rotahaler, It should be with device, so that other

companies can also participate and you will get more

competition for the product.

Strength is amended

as 18mcg, while pack

amended as 30capx6

pack with dispensing

device

36 120783

LEVOSALBUT

AMOL 100 mcg

+

IPRATROPIUM

BROMIDE 40

mcg Rotacaps

30cap.x

6 pack

with 1

rotahale

r

200

In pack size you have mention Rotahaler, which is the

device name of one company only. Instead of




Pack amended as

30cap.x6pack with

dispensing device




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37 120782

Levosalbutamol

100mcg

Rotacaps

30cap.x

6 pack

with 1

rotahale

r

100






Pack amended as

30cap.x6pack with

dispensing device

38 120777

FORMOTEROL

FUMARATE

12Mcg +

FLUTICASONE

PROPIONATE

500 mcg

Rotacaps

30cap.x

6 pack

with 1

rotahale

r

200






Pack amended as

30cap.x6pack with

dispensing device

39 120771 Tenecteplase

50mg Injection

Injectio

n 98

Change of Specification from Tenecteplase 50mg

injection to Tenecteplase 40mg Injection.

1- Tenecteplase 50mg Inj is not available in India.

2- All other States are procuring Tenecteplase 40mg

Injection only.

3- Previous MPPHSCL tender got Non quoted

becasue of non availability of Tenecteplase 50 mg Inj.

in Indian Market.

Strength is amended

as 40mg

40 120768 Ivabradel 5mg

Tablet 10x10 195

Ivabradine Hydrochloride 5mg Tablet -Mis-spelt in

tender enquiry

Product Name

amended as

Ivabradine 5mg

Tablet

41 120711 Basal Insulin

Glargin 40IU/ml

10 ml

vial

20000 Incorrect product description and no organization

manufacture product with such descripition, No Change

42 120672 Tianeptin Tablet

12.5 mg 10 x 10 100

Tianeptine Sodium B.P 12.5mg -Mis-spelt in tender

enquiry

Product name

amended as

Tianeptine Tablet

12.5mg

43 120599 Surgical Spirit IP 500mL

Bottle 230107

1. As per previous tender this items were in the

surgical and consumable tender and it has exemption

of WHO GMP certificate in above items. Please

consider as per last tender.

2. Request you to please relax WHO_GMP in view of

External and Spiritous item. Please insist for GMP as

per Schedule M. Kindly find attached Letter

No Change

44 120533

Mometasone

0.10% Ointment/

Cream

15gm 80700

Item Specification need to changed-:

MOMETASONE FUROATE 0.1% w/v- Cream Mometasone Furoate

also acceptable

45 120528

Metoprolol +

Amlodipin 25

mg + 2.5 mg

Tablet

10 x 10 330

Item Specification need to changed-: METOPROLOL

25 mg + AMLODIPINE 5 mg No Change

46 120524

Metformin +

Glimepiride 500

mg + 2 mg

Tablet

10 x 10 1278

Usually metformin in combination with Glimepiride

or any other drug is always in sustained release form

i.e. SR form. And Further we have Metformin 500 mg

as sustained release form and Glimepiride 2 mg.

Please amend the NIT suitably.

SR form also

acceptable




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47 120497 Gluteraldehyde

Solution 2%

5 litre

Can,sol

ution

1704

Request you to please relax WHO_GMP in view of

External and Dis-infectant. Please insist for GMP as

per Schedule M. Kindly find attached

Letter

No Change

48 120398 Cefpodoxime

100 mg Tablet 10x10 5385

Item specification allow to quote-: CEFPODOXIME

100 mg DT Tablet DT tablet also

acceptable

49 120361

Levocetirizine +

Monteleukast 2.5

mg + 4 mg) / 5

ml, 30 ml

Bottle),Suspensi

on

30ml

Bottle 611625

Item SKU allow to quote-: 60ml

Pack amended as

60ml Bottle

50 120340

Daunorubicin

Injection 50 mg /

vial

vial 3074

Item standard specification & Unit(SKU)-:

Daunorubicin HCL 20mg /Vial

No Change since

Daunorubicin

Injection 20 mg / vial

already available in

Live RC

51 120099

Dacarbazine Inj.

(DTIC)(500 mg

Vial),Injection

Vial 1095

Item specification allow to quote-: DACARBAZINE

USP 500 mg With USP status also

accepted

52 120006

Acyclovir Tab

400 mg(400

mg),Tablet

10x10 3327

Item specification allow to quote-: ACICLOVIR 400

mg DT Tab. DT tablet also

acceptable

53 110432

Tincture Benzoin

CompoundSoluti

on

10 ml

bottle 76690


External and Tincture Item. Please insist for GMP as

per Schedule M. Kindly find attached

Letter

No Change

54 110425

Lysol IP Cresol

with Soap

Solution)

5Ltr jar 3686


External and Dis-infectanat item. Please insist for

GMP as per Schedule M. Kindly find attached

Letter

Item Deleted. Will be

published in

consumables tender.

55 110384

Surfactant

bovine 135 mg

phopholipid per

5 ml)

5ml vial 1946

1- Please change strength of this product as per last

approved tender (Tender Ref.no.67/MPPHSCL/

Pharma/RC/2016, Dt. 05.03.2016) of this product:-

Surfactant (natural bovine lung surfactant) Intratraheal

100mg of phospholipids per kg of birth weight/vial

2- Your require unit for this product is Unit (SKU)- 5

ml vial in this tender. We request you that please

change uit for this product is unit (SKU)-Vial as per

last approved tender (Tender Ref. No. 67/MPPHSCL

/Pharma/RC/2016, Dt. 05.03.2016) of this product.

3- Your require quantity for supply -1946 vials for

this tender, this is very high quantity. As per our

knowledge, this product never purchased in this

quantity by you. So we request you that please reduce

this quantity for supply -780 vials as per last approved

tender (Tender Ref. No. 67/MPPHSCL/

Pharma/RC/2016 Dt. 05.03.16) of this product.

Amended as -

Product name

Surfactant (bovine

lung surfactant)

Intratracheal

minimum 100 mg

phospholipids /vial

SKU / Pack; Vial

Quantity- No Change

Price should be

quoted per vial.




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56 110315

Rabies

Immunoglobulin

Inj-300 IU / 2ml

2ml

vial/PF

S

7710

We are very happy to inform you that, our company

has introduced 'Rabishield', which is a better

alternative to Rabies Immunoglobulin

Injections.Rabishield will not only save huge

government revenue, because price of Rabishield

being much lesser than price of HRIG, but also reduce

the risk of adverse events. Moreover being a

recombinant product, the supplies of Rabishield will

be uninterrupted.The recent WHO guidelines,

published in April 2018 ( copy attached ), clearly

highlight the advantages of R-Mab (Rabishield) over

ERIG and HRIG and further state that the use of R-

Mab should be encouraged instead of any

RIG.Attached herewith please find relevant pages of

WHO guidelines for your readyreference.We have

requested MPPHSCL authorities to include Rabishield

in their procurement list, the copy of which is attached

herewith.Therefore, we sincerely request you to

support a new and novel way of Rabiesprophylaxis by

prescribing 'Rabishield'.

No Change

57 110290 Ondansetron Tab

4 mg 10x10 134136

We have Ondansetron Orally Disintegrating Tablets

IP 4 mg and MMC is there for 2 years only. Can we

stiil quote orally Disintegrating tablets (ODT) have

advantage of ease of Administration and rapid onset

of action.

DT tablet also

acceptable

58 110259 Glycerine IP

Solution

100ml

Bottle 92680

As per previous tender this items were in the surgical

and consumable tender and it has exemption of WHO

GMP certificate in above items. Please consider as per

last tender.

No Change

59 110256

Gamma Benzene

Hexachloride

solution 1%

100 ml

Bottle 504768




last tender.

No Change

60 110255 Benzyl Benzoate

lotion 25%

100ml

bottle

141691

0




last tender.

No Change

61 110247

Cetrimide 15%

w/v +

Chlorhexidine

1.5% w/v

1 liter

bottle 38602




last tender.

No Change

62 110193

Enoxaparin(60m

g equivalant to-

6000 IU

vial/PFS),Injecti

on

Vial/PF

S 246320

The quantity mentioed in the tender document for the

said product is 246320 PFS. Generally, we do not find

such huge quantity in any tender all over india. We

request you to kindly Re-check the quantity.

SKU Qty amended as

70000

63 110046 Levocetirizine

Tab 5mg 10x10 296810

We have levocetriziae Tab 5 mg as Mouth Dissolving

Tablets. Can we quote for the same. Levocetirizine

5mg Mouth Dissolving Tablet is a medicinal teblet

gets instantly dissolved in the mouth, thus speeding

the reaction. tablets are the most comman solid dosage

form, administered orally, but many patients specially

Mouth dissolving

tablet also acceptable




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children, mentally ill patients and geriatrics have

problem in swallowing thetablets. Mouth Dissolving

Tablets have advantage of ease of administration and

repid onset of action. Further there is aavantage of

repid disintegration without use of water in oral

cavity. When NDT is kept in oral cavity then saliva

quickly penetrates into tablet pores and causes rapid

disintegration.

64 110032

Altracurium

(10mg/ml,2.5ml

vial),Injection

Vial 39852

Most of the companies are manufacturing in Amp

form. In the event, tendered in Amp/Vial forms, it will

increase the competition and your Institution will get

best of the rates.

Product Name

ammended as

Atracurium

(10mg/ml,2.5ml

amp/vial),Injection

65

110003 Ketamine

hydrochloride

Inj. 10mg/ml

10ml vial 49540 Quantity is very high, pls reduce the Quantity No Change

66

110004 Propofol

Sodium Inj

1%w/v

10mg/ml

(10mg/ml),Vial

20ml

Vial

30450 Quantity is very high, pls reduce the Quantity No Change

67

110013 Glycopyrrolate

inj. - 0.2 mg/ml

Injection

1ml Amp 114890 Quantity is very high, pls reduce the Quantity No Change

68

110014 Midazolam Inj.

- 1mg/ml 5ml

Amp

5ml Amp 175802 Quantity is very high, pls reduce the Quantity No Change

69

110192 Enoxaparin(40

mg equivalent

to- 4000 IU

Vial/PFS),Inject

ion

Vial/PFS 79600 Quantity is very high, pls reduce the Quantity No Change

70 110222 Labetalol 20 mg

/ 4 ml Inj

4 ml

Amp


71

110340 Fluconazole Ear

drop 0.3%

5ml vial 200000 Recommendate specification Fluconazole Eye/Ear

drop 0.3% - same formulation used for eye drops and

ear drops.

Item amended as

Fluconazole Ear/Eye

drop 0.3% 5 ml vial

72

120119 Enoxaparin

20mg/0.2ml)

Injection

0.2 ml

Prefilled

Syringe ,


73

120149 Haemocoagulas

e Injection 1 IU

/ ml

1 ml amp 38818 Quantity is very high, pls reduce the Quantity No Change




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74

120157 Human

Chorionic

Gonadotropin

5000 IU / ml

Injection

vial 9000 Item already in NIT165 hence remove from product

list of NIT185

No Change

75

120177 Ketamine

hydrochloride

inj 50mg/mL

10 ml

vial


76

120194 Mephentermine

Inj 30mg/ml

10 ml

Vial,Inje

ction


77

120262 Propofol

Sodium 1% w/v

10mg/ml, 10ml

Vial),Injection

10ml vial 27060 Quantity is very high, pls reduce the Quantity No Change

78

- - - - Supply period should be 60 days for

Tablet/Capsule/Syrups/Ointment, for injectable it

should be 75 days.

No Change

79 - - - - There is no need of COPP for every product as plant

is WHO-GMP.

No Change

80

- - - - Payment should be in 60 days only, if we got the

payment after 60 days 18% of interest should be paid

by corporation.

No Change

81

- - - - In point no. 18.2 of tender terms and condition

mentioned supply period is of 60 days, in which our

request it provide 30 days more i.e 90 days without

LD as most of our products are manufactured under

sterile condition, to maintain the quality and standard

of product.

No Change

82

- - - - As per tender the supply should be completed within

45 days from the date of purchase order. However, for

injectable drugs supply can be completed within60

days from the date of supply order. Ophtalmic

preparations are also sterile product & delivery period

should be similar to injectables i.e. instead of 45 days

it should be 60 days.

No Change

Other Product Specific Amendments

1 120690

HPMC

(hydroxy

propylmethyl

cellulose)

Injection 5%

5ml 20000 Pack and quantity amendment

Pack amended as 5ml

PFS and Qty

amended as 30000




of 12

S.

N.

Produc

t

Code

Product Name SKU

(Pack)

Approx

.

SKU

Qty.


Resolution

2 120855

Hydroxy Propyl

Methyl

Cellulose

Injection 10%

5ml

Prefilled

Syringe

15000 Product name and quantity amendment.

Product Name

amended as Hydroxy

Propyl Methyl

Cellulose Injection

2%, Qty amended as

30000

3 120727 Ifosphamide +

Mesna 1gm inj Vial 1630

Repeated entry, item need to delete Item Deleted

4 120281 Tamoxifen(10

mg),Tablet 10X10 1587

Item Already approved in NIT165 Item Deleted

-SD-

CGM(Technical)

MPPHSCL

madhya pradesh public health services corporation limited ... · report (certificate of analysis)...

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